Surgical Techniques

Choosing appropriate surgical interventions is the focus of the second of our 2-part panel on stress urinary incontinence (SUI). The panelists discuss:

• how to weigh the factors that influence choice of technique, including Burch retropubic urethropexy and the various sling operations;
• the challenges of treating “mixed” stress and urge incontinence; and
• when to use bulking agents for intrinsic sphincteric deficiency.

The panelists also share tips on:

• how to help patients accurately describe their symptoms, and
• what issues to review with patients as they consider their options.

Part 1 covered medical therapies such as pelvic floor muscle rehabilitation, occlusive devices, and drugs. (Stress urinary incontinence: A closer look at nonsurgical therapies. OBG Management. 2003;15(9):40-51.)

Review surgical options with the patient

SAND: How do you counsel patients about surgical treatments for stress urinary incontinence?

MYERS: After the initial evaluation and diagnosis, I review the conservative options, and I also offer surgery. At this time, I discuss whether an operation is appropriate.

I work with the patient, going over her diagnosis as well as the different types of operations that are performed. Some patients are fairly well educated about their options, having looked up information on the Internet.

Next I explore whether other types of procedures need to be done concomitantly. For instance, does the patient need abdominal hysterectomy for some other reason? That would prompt me to offer an abdominal approach to the SUI. Do other types of vaginal surgery need to be done? Then I would probably opt for a vaginal approach.

I also look at the patient’s health status. Is she healthy and physically active? Or is she sedentary with comorbidities? In a woman who is a poor surgical candidate, I would consider less invasive procedures or procedures with less operative risk, such as urethral injections or the newer tape slings.

LUBER: When it comes to surgery for urinary incontinence, I like to reinforce the reconstructive nature of the repair, since patients tend to view surgical procedures as definitive. For example, when the uterus and ovaries are removed, they never bother that patient again. Incontinence procedures are different. Their effect is potentially time-limited, so it’s important to reinforce the patient’s understanding of their reconstructive and fallible nature.

At the first surgical consultation, I basically go through an informed consent. I do so again preoperatively, but I think it is a very important initial step for a patient who is considering surgery.

SAND: What if a patient isn’t sure she wants surgery?

LUBER: When a patient asks, “What should I do, Dr. Luber? Should I have an operation?” I like to use the example of standing in front of the refrigerator and asking, “Gee, am I hungry?” If you have to ask, you probably aren’t.

Potential surgical patients should feel extremely comfortable that they have exhausted all the nonsurgical options. Even if they have decided against nonsurgical therapy, they should feel very comfortable with that choice. Then I am confident we can work through any potential problems of surgery.

As for the operation itself, history has demonstrated the irresistible impulse to innovate during surgery for female stress incontinence. Literally hundreds of operations have been described, and dozens are currently in use; this reinforces the supposition that our techniques are imperfect, and the importance of basing what we do upon the available data. The 1997 American Urological Association guidelines are an excellent example. Looking forward, the National Institutes of Health are sponsoring studies comparing, for example, the goldstandard Burch to the goldstandard sling operation. In the next few years, we should have better evidence-based guidance.

Consider patient characteristics when choosing treatment

SAND: How do you select a surgical procedure for a particular patient?

MYERS: Because of all the different variables, I use various treatment arms. Since my institution does a large number of sling procedures, I am very comfortable performing those operations. I still do retropubic urethropexy. I also do the newer vaginal-tape procedures, and I use bulking agents for patients who have a demonstrated sphincter deficiency with no obvious support problems. Basically, I try to tailor my procedure to the patient.

For example, in a woman who requires a total abdominal hysterectomy for fibroids as well as an anti-incontinence procedure, I would do a Burch operation. For a woman who needed a vaginal hysterectomy, I probably would perform a sling procedure.

DAVILA: Ob/Gyns may be a bit unsure how to proceed at this point. For example, we formerly considered the Burch procedure the gold standard against which other procedures should be judged. Although I continue to view it as the standard, the Burch procedure increasingly is overlooked in favor of tension-free slings—due to increased marketing of the latter—for any form of stress incontinence. I think that has led us down a path that is not entirely beneficial for many of our patients.

In contrast to that approach, I use a basic evaluation of the patient to construct a treatment algorithm. In simple terms, 2 factors are taken into account: urethral sphincter function and bladder neck or urethral support. Using those 2 factors, I create a 2×2 table to select patients who do or don’t have urethral hypermobility and who do or don’t have sphincteric deficiency (TABLE).

For example, a patient with hypermobility and normal sphincter function has what we might consider “garden-variety” stress incontinence. Such patients do well with any form of treatment, whether it’s conservative therapy, a vaginal device, or a Burch procedure or tension-free sling.

I am more concerned when the patient has hypermobility with a significant degree of sphincteric deficiency. In recent years, the tendency has been to treat such patients with a tension-free sling. Although the literature is not absolutely clear, the success rate of tension-free slings in a patient with intrinsic sphincteric deficiency (ISD) is not as high as in a woman without ISD.¹ So in these patients, I do a traditional sling.

Atrophy can cause significant urgency and nocturia symptoms.—Dr. Davila

The other 2 groups of patients have no hypermobility. I think most of us would agree that a woman with ISD and no hypermobility would best be treated with a bulking agent such as Contigen (C.R. Bard, Murray Hill, NJ) or Durasphere (Advanced Uroscience, St. Paul, Minn).

I have had good success rates with bulking agents. I do not think current data would support a tension-free sling in these patients.

Finally, there is the patient without hypermobility who has normal sphincter function. These patients do fairly well with conservative therapy, including pelvic floor exercises. They usually have mild forms of stress incontinence to begin with.

TABLE 1

Stress urinary incontinence treatment choices based on urethral support and urethral sphincteric function

Simple method to assess sphincter function

DAVILA: This is the algorithm I tend to follow. It does entail evaluation of the urethral sphincter mechanism, but there are simpler ways to do that than with multi-channel urodynamics. For example, if the patient leaks with a Valsalva maneuver, after voiding, in a supine position, that suggests she has ISD and therefore is likely to have a low-pressure urethra or a low leak-point pressure. Multiple centers have reported on this.^2,3

Role of urethral function in choice of treatment

LUBER: There seems to be 2 schools. The first dichotomizes urethral function to reasonable (“good” urethral function) versus unreasonable (“poor” urethral function or ISD) and selects the operation based on that. Thus, a Burch or supportive operation would be used for good urethral function with hypermobility, and a sling operation would be selected for poor urethral function or ISD.

More recently, some experts have preached an inclusive approach, whereby all patients undergo sling operations. That strategy evolved out of frustration over the difficulty of identifying which patients have poor urethral function. Unfortunately, we lack good long-term data on the potential downside of performing sling procedures on all patients with incontinence. Hopefully, over the next 3 years, the National Institutes of Health data will help clarify whether we need to dichotomize patients in terms of urethral function.

Meanwhile, at our center, we continue to consider urethral function the deciding factor as to whether patients will undergo a gold-standard Burch procedure or a sling. We steer toward a sling procedure when the patient clearly has poor urethral function or ISD. Of course in cases of the fixed immobile and poorly functioning urethra, we also make bulking agents available.

Additional factors in the choice of treatment

SAND: We throw 2 other things into the algorithm at our center: One is detrusor overactivity, which is very important when considering surgical treatment of stress urinary incontinence. The second is voiding function.

Activity level of the patient is an additional measure, as Dr. Myers commented on earlier. I’m not as concerned about age as I am about the patient’s physical activity and expectations for the operation over time. For example, for a woman who is relatively homebound and not physically active and has poor voiding function (underactive detrusor) and prolapse with normal intrinsic urethral function, a Kelly Kennedy procedure at the time of an anterior colporrhaphy may be more appropriate than a Burch procedure.

Detrusor overactivity is important because, in the trial that we performed, the Burch retropubic urethropexy had a 55% objective cure rate of concurrent detrusor overactivity and a 70% subjective cure rate of the symptom of urge urinary incontinence. In contrast, over the last 12 years, the sling procedure has had a resolution rate of between 20% and 28% for recurrent detrusor overactivity. Recent subjective data at 1 year for midurethral slings fall into the same range: 20% to 30% resolution of recurrent urge incontinence.

Another factor is de novo detrusor overactivity. The rate of de novo detrusor overactivity and urge incontinence in our sling patients seems consistently higher, compared with our retropubic urethropexy patients. We all know that the patient with urge incontinence is far more upset about her condition than the patient who has predictable stress incontinence, because urge incontinence can be far more destructive to quality of life. I try to encourage gynecologists to consider this factor.

Voiding function is less clear-cut. Basically, because intrinsic urethral function declines with age, it is not uncommon to see a woman in her 70s or 80s with ISD who also has absent detrusor contractions during voiding studies. The physician can assess this function by ultrasound or urodynamic testing, or by measuring the postvoid residual volume, which usually falls in the range of 100 to 200 mL, especially if no prolapse is present. Thus, even in cases in which I normally would want to do a sling for ISD, I opt against it if the patient has poor voiding function. That’s because the risk of permanent retention may rise as high as 15% to 20% in some of these patients.

Evaluation and treatment of mixed incontinence

DAVILA: I think we all agree that incontinence is easier to address than “hypercontinence” resulting from postoperative urethral obstruction, urinary retention, and irritative voiding symptoms. But what about patients with mixed incontinence? How do you evaluate them? Is there a role for surgical procedures in patients with primary urge incontinence?

I believe in offering all patients both nonsurgical and surgical options.—Dr. Sand

SAND: Many centers offer nonsurgical treatment of mixed incontinence, especially if urge incontinence predominates. But I believe in offering all patients both nonsurgical and surgical options. I end up triaging based on what patients select first, regardless of whether they have pure SUI or mixed symptoms, as long as they have been counseled appropriately about the expected outcomes of the various options.

MYERS: In my practice, I treat the urge symptoms first with anticholinergics or other medications. Then, if the stress incontinence continues, I offer a procedure.

This may be difficult in some cases, such as a patient with severe ISD. It is hard to treat detrusor overactivity when the urethral sphincter is weak, as the woman cannot hold increasing volumes of urine in the bladder.

Thus, I approach these cases by treating the stress incontinence first and then the urgency symptoms if intervention is still necessary—which is a 180-degree shift from my previous statement. In these cases, I treat the ISD first. Then, after the stress incontinence resolves, I offer medications for the urgency.

LUBER: I want to throw a little cold water on surgical treatment of overactive bladder. Clearly, this is an enormous issue. Probably 40% of women who come to my office complaining of urinary incontinence have mixed symptoms or mixed disease as determined by urodynamics. For the doctors out there caring for these patients daily, I think it is important to remember, as Dr. Sand mentioned, that in some cases, anti-incontinence operations can provoke detrusor overactivity in patients who were relatively asymptomatic previously. Dr. Myers’ suggestion that surgery may simply unmask the detrusor overactivity is also possible, of course.

Probably 40% of women who come to my office complaining of urinary incontinence have mixed symptoms.—Dr. Luber

Thus, I think it is reasonable to ask patients reporting mixed symptoms to characterize their urine loss. I usually have them pick a percentage (which isn’t always easy). I ask, “Is your urge incontinence 10%, 50% or 90% of your problem?” If urgency is 90% of the problem and stress incontinence is minimal, then naturally that patient’s care should be focused on the urge incontinence, and vice versa.

It becomes more problematic in the middle, with that 50/50 group. But I’m old-fashioned in that I like to treat the urge incontinence first and get that under control. Of course, in women with poor sphincter function, this distinction becomes more difficult because of the inevitable overlap of symptoms. But this is a small subset of the whole population.

DAVILA: Even if you operate on these patients to correct sphincter function, you must follow them closely. You shouldn’t be saying, “We’ll see you in 6 months.”

In addition, the cofactor of urogenital atrophy should be addressed. Atrophy can cause significant urinary urgency and nocturia symptoms, although most women may not report vaginal atrophy symptoms.⁴ Local estrogen cream at a low dosage can be used pre- and postoperatively without concern about systemic absorption.⁵

Which patients benefit from bulking agents?

SAND: We touched on the use of periurethral injections of bulking agents. How do you determine when bulking agents are appropriate?

MYERS: I use periurethral injections for demonstrated sphincter deficiency. The ideal patient has a supported bladder neck and true sphincter deficiency—for example, patients whose sphincter deficiency is caused by pelvic radiation or significant surgical scarring.

In recent years, I have loosened the guidelines slightly, in that a number of my patients are elderly women with urethral hypermobility who are not healthy enough to undergo a major operation. In these patients, I use a pessary to support the bladder neck before performing an injection, and I make sure the patient understands that she will need to use the pessary even after the injection. I have better results when there is no hypermobility.

LUBER: The concept of ISD as the sole cause of urinary incontinence is less mysterious than it at first appears. In the typical patient with a fixed poorly functioning urethra, a Qtip test will be 0 degrees at rest, and will still be 0 degrees with straining. The patient will leak readily with any kind of provocative maneuver, be it coughing or slight straining. With or without urodynamics, we know that patient’s urethra is not functioning properly. Such a patient, for me, is the ideal candidate for bulking agents.

Unfortunately, bulking agents tend to have short half-lives of around 2 years. Still, you can improve the quality of life of these patients tremendously in that time by periurethrally injecting bulking agents during a very simple office or outpatient visit.

I have had less satisfaction and success using bulking agents in patients with urethral hypermobility, although I do like Dr. Myers’ idea of correcting the hypermobility with an intravaginal support device and then using collagen to improve their urethral coaptation. That’s a nice concept.

Improvements being studied

SAND: Currently, we have 2 injectables approved by the US Food and Drug Administration: collagen and carbon-coated microspheres. Are new agents coming out? Do you expect improvements in the current agents?

DAVILA: The number of bulking agents being studied right now is huge. I think the future will bring one that can be implanted without the need for cystoscopy. A couple of trials under way use a conical urethral template for needle placement, and the injection is performed without cystoscopy. Although we’re a number of years away from having enough data to support the widespread implementation of this approach, the momentum is certainly in that direction.

The half-lives of bulking agents also are increasing. Collagen was an excellent start, but we are moving toward permanence. In addition, most of the agents being studied are simpler to inject than collagen. Biotechnology is coming to the forefront with polymers that are either temperature-sensitive or able to reconfigure themselves over time. Thus, they should serve as a nidus for collagen deposition or remain in place longer, enhancing urethral sphincteric function.

It isn’t clear which agent will take a leading role in the next few years, but a number of them have great promise. This is an exciting time in the management of stress incontinence as we move from invasive procedures such as retropubic urethropexy to minimally invasive surgery—as well as from the operating room to the office.

Radiofrequency technologies

SAND: What do you think about the new radiofrequency technologies being used to create support in periurethral tissues to correct hypermobility? Is there a role for this evolving technology?

LUBER: The concept of developing scar tissue adjacent to the urethra to provide better support underlies much of what we already do surgically. So there is some logic in the use of radiofrequency technologies to accomplish the same thing.

Still, there is the theoretical risk of further denervating the urethra, which is probably already denervated. Having looked at outcome studies for radiofrequency therapy, I think it’s a modality that can be embraced, but that should be done under the auspices of clinical research. Again, I’m old fashioned and am not comfortable integrating untested approaches into routine clinical care until we have adequate evidence of their effectiveness. In caring for incontinence, it is important that this effectiveness be looked at over a reasonable period of time, for example, 48 months.

It is hard to treat detrusor overactivity when the urethral sphincter is weak.—Dr. Myers

DAVILA: I have had some experience with radiofrequency therapy, and the tissue changes it stimulates are fairly impressive. I share your concern about the issue of denervation. In fact, my colleagues and I are hoping to initiate a trial in which we plan to look at pudendal latencies to the urethral sphincter in these patients. As of now, with limited experience, it appears that there is no worsening of urethral sphincter function with the therapy.

Tension-free vaginal tape

SAND: What about other new treatments on the horizon?

DAVILA: Like bulking agents, new minimally invasive surgical techniques are also increasing in number. The advent of the tension-free vaginal tape (TVT), a technique that moved from Sweden to the United States a couple of years ago, truly has revolutionized what we do in anti-incontinence surgery. I think we all can agree that it has changed our practice patterns quite significantly, and the modifications or theoretical improvements by different companies are likely to have a further impact.

Polypropylene mesh appears to be very well received by the body. It doesn’t get rejected or infected at a significant rate, so most physicians are comfortable with it. But I think it has become the surgeon’s preference as to which product works better.

For the Ob/Gyn, the primary issue remains the small yet well-recognized risks of retropubic needle placement, beginning with bladder perforation and including vascular or bowel injury. As a result, many Ob/Gyns have probably been hesitant to perform these procedures.

What the future holds is very exciting: the transobturator approach to surgery for stress incontinence. Instead of bringing the needle superiorly behind the pubic bone, the surgeon maneuvers it laterally beneath the pubic ramus and through the obturator membrane. This is an anti-incontinence procedure a gynecologist can embrace. It may not be necessary to perform cystoscopy afterward because the surgery is nowhere near the bladder.

The French have taken the lead in developing this technique and recently presented approximately 2 years of data.^6,7 A US trial also is being initiated.

LUBER: TVT is billed as a midurethral procedure. However, when you consider where those tapes actually end up after a few months, it probably functions much like a traditional sling. Recent studies are in conflict: Some demonstrate the sling remains at the midurethra while others show that it readily migrates to the bladder neck. So the quest for a less obstructive procedure has not been fulfilled with the TVT.

In fact, in our recent TVT series that Drs. Lukacz and Nager are meticulously following, the voiding time increases and the maximum flow decreases postoperatively in roughly 30% of patients. So it definitely has some obstructive characteristics.

Quest for the Holy Grail continues

LUBER: I think we need to continue to explore these newer, less invasive procedures that offer wonderful potential. At this point, I might employ them in patients who are not able to tolerate the more invasive procedures or who flatly state that they want a less invasive operation. But I am not ready to embrace them as first-line therapy for all of my patients with stress incontinence.

Over the years, we have all seen various waves of surgical innovation, from the noincision urethropexies of the mid-1990s to the laparoscopic techniques prominent later in the decade. Now, more minimally invasive techniques are coming to the fore. At some point, we may even find the Holy Grail. But for the most part, we continue to evolve, examining new approaches until we are forced to reconcile with their limitations.

SAND: It is clear that this is a very exciting time to be treating SUI, with continuing innovation and an increased awareness of the problem by the public. While we all treat these women differently, there is a surprising consensus. We all seem to concur that the operation should be tailored to the individual, considering the relative balance of any concurrent urinary urge incontinence, urethral hypermobility, voiding dysfunction, and the woman’s health and activity level. We all use midurethral slings and periurethral bulking agents in selected women, but still also rely on Burch procedures and bladder-neck slings.

The authors report no financial relationship with any companies whose products are mentioned in this article.

Choosing appropriate surgical interventions is the focus of the second of our 2-part panel on stress urinary incontinence (SUI). The panelists discuss:

• how to weigh the factors that influence choice of technique, including Burch retropubic urethropexy and the various sling operations;
• the challenges of treating “mixed” stress and urge incontinence; and
• when to use bulking agents for intrinsic sphincteric deficiency.

The panelists also share tips on:

• how to help patients accurately describe their symptoms, and
• what issues to review with patients as they consider their options.

Part 1 covered medical therapies such as pelvic floor muscle rehabilitation, occlusive devices, and drugs. (Stress urinary incontinence: A closer look at nonsurgical therapies. OBG Management. 2003;15(9):40-51.)

Review surgical options with the patient

SAND: How do you counsel patients about surgical treatments for stress urinary incontinence?

MYERS: After the initial evaluation and diagnosis, I review the conservative options, and I also offer surgery. At this time, I discuss whether an operation is appropriate.

I work with the patient, going over her diagnosis as well as the different types of operations that are performed. Some patients are fairly well educated about their options, having looked up information on the Internet.

Next I explore whether other types of procedures need to be done concomitantly. For instance, does the patient need abdominal hysterectomy for some other reason? That would prompt me to offer an abdominal approach to the SUI. Do other types of vaginal surgery need to be done? Then I would probably opt for a vaginal approach.

I also look at the patient’s health status. Is she healthy and physically active? Or is she sedentary with comorbidities? In a woman who is a poor surgical candidate, I would consider less invasive procedures or procedures with less operative risk, such as urethral injections or the newer tape slings.

LUBER: When it comes to surgery for urinary incontinence, I like to reinforce the reconstructive nature of the repair, since patients tend to view surgical procedures as definitive. For example, when the uterus and ovaries are removed, they never bother that patient again. Incontinence procedures are different. Their effect is potentially time-limited, so it’s important to reinforce the patient’s understanding of their reconstructive and fallible nature.

At the first surgical consultation, I basically go through an informed consent. I do so again preoperatively, but I think it is a very important initial step for a patient who is considering surgery.

SAND: What if a patient isn’t sure she wants surgery?

LUBER: When a patient asks, “What should I do, Dr. Luber? Should I have an operation?” I like to use the example of standing in front of the refrigerator and asking, “Gee, am I hungry?” If you have to ask, you probably aren’t.

Potential surgical patients should feel extremely comfortable that they have exhausted all the nonsurgical options. Even if they have decided against nonsurgical therapy, they should feel very comfortable with that choice. Then I am confident we can work through any potential problems of surgery.

As for the operation itself, history has demonstrated the irresistible impulse to innovate during surgery for female stress incontinence. Literally hundreds of operations have been described, and dozens are currently in use; this reinforces the supposition that our techniques are imperfect, and the importance of basing what we do upon the available data. The 1997 American Urological Association guidelines are an excellent example. Looking forward, the National Institutes of Health are sponsoring studies comparing, for example, the goldstandard Burch to the goldstandard sling operation. In the next few years, we should have better evidence-based guidance.

Consider patient characteristics when choosing treatment

SAND: How do you select a surgical procedure for a particular patient?

MYERS: Because of all the different variables, I use various treatment arms. Since my institution does a large number of sling procedures, I am very comfortable performing those operations. I still do retropubic urethropexy. I also do the newer vaginal-tape procedures, and I use bulking agents for patients who have a demonstrated sphincter deficiency with no obvious support problems. Basically, I try to tailor my procedure to the patient.

For example, in a woman who requires a total abdominal hysterectomy for fibroids as well as an anti-incontinence procedure, I would do a Burch operation. For a woman who needed a vaginal hysterectomy, I probably would perform a sling procedure.

DAVILA: Ob/Gyns may be a bit unsure how to proceed at this point. For example, we formerly considered the Burch procedure the gold standard against which other procedures should be judged. Although I continue to view it as the standard, the Burch procedure increasingly is overlooked in favor of tension-free slings—due to increased marketing of the latter—for any form of stress incontinence. I think that has led us down a path that is not entirely beneficial for many of our patients.

In contrast to that approach, I use a basic evaluation of the patient to construct a treatment algorithm. In simple terms, 2 factors are taken into account: urethral sphincter function and bladder neck or urethral support. Using those 2 factors, I create a 2×2 table to select patients who do or don’t have urethral hypermobility and who do or don’t have sphincteric deficiency (TABLE).

For example, a patient with hypermobility and normal sphincter function has what we might consider “garden-variety” stress incontinence. Such patients do well with any form of treatment, whether it’s conservative therapy, a vaginal device, or a Burch procedure or tension-free sling.

I am more concerned when the patient has hypermobility with a significant degree of sphincteric deficiency. In recent years, the tendency has been to treat such patients with a tension-free sling. Although the literature is not absolutely clear, the success rate of tension-free slings in a patient with intrinsic sphincteric deficiency (ISD) is not as high as in a woman without ISD.¹ So in these patients, I do a traditional sling.

Atrophy can cause significant urgency and nocturia symptoms.—Dr. Davila

The other 2 groups of patients have no hypermobility. I think most of us would agree that a woman with ISD and no hypermobility would best be treated with a bulking agent such as Contigen (C.R. Bard, Murray Hill, NJ) or Durasphere (Advanced Uroscience, St. Paul, Minn).

I have had good success rates with bulking agents. I do not think current data would support a tension-free sling in these patients.

Finally, there is the patient without hypermobility who has normal sphincter function. These patients do fairly well with conservative therapy, including pelvic floor exercises. They usually have mild forms of stress incontinence to begin with.

TABLE 1

Stress urinary incontinence treatment choices based on urethral support and urethral sphincteric function

Simple method to assess sphincter function

DAVILA: This is the algorithm I tend to follow. It does entail evaluation of the urethral sphincter mechanism, but there are simpler ways to do that than with multi-channel urodynamics. For example, if the patient leaks with a Valsalva maneuver, after voiding, in a supine position, that suggests she has ISD and therefore is likely to have a low-pressure urethra or a low leak-point pressure. Multiple centers have reported on this.^2,3

Role of urethral function in choice of treatment

LUBER: There seems to be 2 schools. The first dichotomizes urethral function to reasonable (“good” urethral function) versus unreasonable (“poor” urethral function or ISD) and selects the operation based on that. Thus, a Burch or supportive operation would be used for good urethral function with hypermobility, and a sling operation would be selected for poor urethral function or ISD.

More recently, some experts have preached an inclusive approach, whereby all patients undergo sling operations. That strategy evolved out of frustration over the difficulty of identifying which patients have poor urethral function. Unfortunately, we lack good long-term data on the potential downside of performing sling procedures on all patients with incontinence. Hopefully, over the next 3 years, the National Institutes of Health data will help clarify whether we need to dichotomize patients in terms of urethral function.

Meanwhile, at our center, we continue to consider urethral function the deciding factor as to whether patients will undergo a gold-standard Burch procedure or a sling. We steer toward a sling procedure when the patient clearly has poor urethral function or ISD. Of course in cases of the fixed immobile and poorly functioning urethra, we also make bulking agents available.

Additional factors in the choice of treatment

SAND: We throw 2 other things into the algorithm at our center: One is detrusor overactivity, which is very important when considering surgical treatment of stress urinary incontinence. The second is voiding function.

Activity level of the patient is an additional measure, as Dr. Myers commented on earlier. I’m not as concerned about age as I am about the patient’s physical activity and expectations for the operation over time. For example, for a woman who is relatively homebound and not physically active and has poor voiding function (underactive detrusor) and prolapse with normal intrinsic urethral function, a Kelly Kennedy procedure at the time of an anterior colporrhaphy may be more appropriate than a Burch procedure.

Detrusor overactivity is important because, in the trial that we performed, the Burch retropubic urethropexy had a 55% objective cure rate of concurrent detrusor overactivity and a 70% subjective cure rate of the symptom of urge urinary incontinence. In contrast, over the last 12 years, the sling procedure has had a resolution rate of between 20% and 28% for recurrent detrusor overactivity. Recent subjective data at 1 year for midurethral slings fall into the same range: 20% to 30% resolution of recurrent urge incontinence.

Another factor is de novo detrusor overactivity. The rate of de novo detrusor overactivity and urge incontinence in our sling patients seems consistently higher, compared with our retropubic urethropexy patients. We all know that the patient with urge incontinence is far more upset about her condition than the patient who has predictable stress incontinence, because urge incontinence can be far more destructive to quality of life. I try to encourage gynecologists to consider this factor.

Voiding function is less clear-cut. Basically, because intrinsic urethral function declines with age, it is not uncommon to see a woman in her 70s or 80s with ISD who also has absent detrusor contractions during voiding studies. The physician can assess this function by ultrasound or urodynamic testing, or by measuring the postvoid residual volume, which usually falls in the range of 100 to 200 mL, especially if no prolapse is present. Thus, even in cases in which I normally would want to do a sling for ISD, I opt against it if the patient has poor voiding function. That’s because the risk of permanent retention may rise as high as 15% to 20% in some of these patients.

Evaluation and treatment of mixed incontinence

DAVILA: I think we all agree that incontinence is easier to address than “hypercontinence” resulting from postoperative urethral obstruction, urinary retention, and irritative voiding symptoms. But what about patients with mixed incontinence? How do you evaluate them? Is there a role for surgical procedures in patients with primary urge incontinence?

I believe in offering all patients both nonsurgical and surgical options.—Dr. Sand

SAND: Many centers offer nonsurgical treatment of mixed incontinence, especially if urge incontinence predominates. But I believe in offering all patients both nonsurgical and surgical options. I end up triaging based on what patients select first, regardless of whether they have pure SUI or mixed symptoms, as long as they have been counseled appropriately about the expected outcomes of the various options.

MYERS: In my practice, I treat the urge symptoms first with anticholinergics or other medications. Then, if the stress incontinence continues, I offer a procedure.

This may be difficult in some cases, such as a patient with severe ISD. It is hard to treat detrusor overactivity when the urethral sphincter is weak, as the woman cannot hold increasing volumes of urine in the bladder.

Thus, I approach these cases by treating the stress incontinence first and then the urgency symptoms if intervention is still necessary—which is a 180-degree shift from my previous statement. In these cases, I treat the ISD first. Then, after the stress incontinence resolves, I offer medications for the urgency.

LUBER: I want to throw a little cold water on surgical treatment of overactive bladder. Clearly, this is an enormous issue. Probably 40% of women who come to my office complaining of urinary incontinence have mixed symptoms or mixed disease as determined by urodynamics. For the doctors out there caring for these patients daily, I think it is important to remember, as Dr. Sand mentioned, that in some cases, anti-incontinence operations can provoke detrusor overactivity in patients who were relatively asymptomatic previously. Dr. Myers’ suggestion that surgery may simply unmask the detrusor overactivity is also possible, of course.

Probably 40% of women who come to my office complaining of urinary incontinence have mixed symptoms.—Dr. Luber

Thus, I think it is reasonable to ask patients reporting mixed symptoms to characterize their urine loss. I usually have them pick a percentage (which isn’t always easy). I ask, “Is your urge incontinence 10%, 50% or 90% of your problem?” If urgency is 90% of the problem and stress incontinence is minimal, then naturally that patient’s care should be focused on the urge incontinence, and vice versa.

It becomes more problematic in the middle, with that 50/50 group. But I’m old-fashioned in that I like to treat the urge incontinence first and get that under control. Of course, in women with poor sphincter function, this distinction becomes more difficult because of the inevitable overlap of symptoms. But this is a small subset of the whole population.

DAVILA: Even if you operate on these patients to correct sphincter function, you must follow them closely. You shouldn’t be saying, “We’ll see you in 6 months.”

In addition, the cofactor of urogenital atrophy should be addressed. Atrophy can cause significant urinary urgency and nocturia symptoms, although most women may not report vaginal atrophy symptoms.⁴ Local estrogen cream at a low dosage can be used pre- and postoperatively without concern about systemic absorption.⁵

Which patients benefit from bulking agents?

SAND: We touched on the use of periurethral injections of bulking agents. How do you determine when bulking agents are appropriate?

MYERS: I use periurethral injections for demonstrated sphincter deficiency. The ideal patient has a supported bladder neck and true sphincter deficiency—for example, patients whose sphincter deficiency is caused by pelvic radiation or significant surgical scarring.

In recent years, I have loosened the guidelines slightly, in that a number of my patients are elderly women with urethral hypermobility who are not healthy enough to undergo a major operation. In these patients, I use a pessary to support the bladder neck before performing an injection, and I make sure the patient understands that she will need to use the pessary even after the injection. I have better results when there is no hypermobility.

LUBER: The concept of ISD as the sole cause of urinary incontinence is less mysterious than it at first appears. In the typical patient with a fixed poorly functioning urethra, a Qtip test will be 0 degrees at rest, and will still be 0 degrees with straining. The patient will leak readily with any kind of provocative maneuver, be it coughing or slight straining. With or without urodynamics, we know that patient’s urethra is not functioning properly. Such a patient, for me, is the ideal candidate for bulking agents.

Unfortunately, bulking agents tend to have short half-lives of around 2 years. Still, you can improve the quality of life of these patients tremendously in that time by periurethrally injecting bulking agents during a very simple office or outpatient visit.

I have had less satisfaction and success using bulking agents in patients with urethral hypermobility, although I do like Dr. Myers’ idea of correcting the hypermobility with an intravaginal support device and then using collagen to improve their urethral coaptation. That’s a nice concept.

Improvements being studied

SAND: Currently, we have 2 injectables approved by the US Food and Drug Administration: collagen and carbon-coated microspheres. Are new agents coming out? Do you expect improvements in the current agents?

DAVILA: The number of bulking agents being studied right now is huge. I think the future will bring one that can be implanted without the need for cystoscopy. A couple of trials under way use a conical urethral template for needle placement, and the injection is performed without cystoscopy. Although we’re a number of years away from having enough data to support the widespread implementation of this approach, the momentum is certainly in that direction.

The half-lives of bulking agents also are increasing. Collagen was an excellent start, but we are moving toward permanence. In addition, most of the agents being studied are simpler to inject than collagen. Biotechnology is coming to the forefront with polymers that are either temperature-sensitive or able to reconfigure themselves over time. Thus, they should serve as a nidus for collagen deposition or remain in place longer, enhancing urethral sphincteric function.

It isn’t clear which agent will take a leading role in the next few years, but a number of them have great promise. This is an exciting time in the management of stress incontinence as we move from invasive procedures such as retropubic urethropexy to minimally invasive surgery—as well as from the operating room to the office.

Radiofrequency technologies

SAND: What do you think about the new radiofrequency technologies being used to create support in periurethral tissues to correct hypermobility? Is there a role for this evolving technology?

LUBER: The concept of developing scar tissue adjacent to the urethra to provide better support underlies much of what we already do surgically. So there is some logic in the use of radiofrequency technologies to accomplish the same thing.

Still, there is the theoretical risk of further denervating the urethra, which is probably already denervated. Having looked at outcome studies for radiofrequency therapy, I think it’s a modality that can be embraced, but that should be done under the auspices of clinical research. Again, I’m old fashioned and am not comfortable integrating untested approaches into routine clinical care until we have adequate evidence of their effectiveness. In caring for incontinence, it is important that this effectiveness be looked at over a reasonable period of time, for example, 48 months.

It is hard to treat detrusor overactivity when the urethral sphincter is weak.—Dr. Myers

DAVILA: I have had some experience with radiofrequency therapy, and the tissue changes it stimulates are fairly impressive. I share your concern about the issue of denervation. In fact, my colleagues and I are hoping to initiate a trial in which we plan to look at pudendal latencies to the urethral sphincter in these patients. As of now, with limited experience, it appears that there is no worsening of urethral sphincter function with the therapy.

Tension-free vaginal tape

SAND: What about other new treatments on the horizon?

DAVILA: Like bulking agents, new minimally invasive surgical techniques are also increasing in number. The advent of the tension-free vaginal tape (TVT), a technique that moved from Sweden to the United States a couple of years ago, truly has revolutionized what we do in anti-incontinence surgery. I think we all can agree that it has changed our practice patterns quite significantly, and the modifications or theoretical improvements by different companies are likely to have a further impact.

Polypropylene mesh appears to be very well received by the body. It doesn’t get rejected or infected at a significant rate, so most physicians are comfortable with it. But I think it has become the surgeon’s preference as to which product works better.

For the Ob/Gyn, the primary issue remains the small yet well-recognized risks of retropubic needle placement, beginning with bladder perforation and including vascular or bowel injury. As a result, many Ob/Gyns have probably been hesitant to perform these procedures.

What the future holds is very exciting: the transobturator approach to surgery for stress incontinence. Instead of bringing the needle superiorly behind the pubic bone, the surgeon maneuvers it laterally beneath the pubic ramus and through the obturator membrane. This is an anti-incontinence procedure a gynecologist can embrace. It may not be necessary to perform cystoscopy afterward because the surgery is nowhere near the bladder.

The French have taken the lead in developing this technique and recently presented approximately 2 years of data.^6,7 A US trial also is being initiated.

LUBER: TVT is billed as a midurethral procedure. However, when you consider where those tapes actually end up after a few months, it probably functions much like a traditional sling. Recent studies are in conflict: Some demonstrate the sling remains at the midurethra while others show that it readily migrates to the bladder neck. So the quest for a less obstructive procedure has not been fulfilled with the TVT.

In fact, in our recent TVT series that Drs. Lukacz and Nager are meticulously following, the voiding time increases and the maximum flow decreases postoperatively in roughly 30% of patients. So it definitely has some obstructive characteristics.

Quest for the Holy Grail continues

LUBER: I think we need to continue to explore these newer, less invasive procedures that offer wonderful potential. At this point, I might employ them in patients who are not able to tolerate the more invasive procedures or who flatly state that they want a less invasive operation. But I am not ready to embrace them as first-line therapy for all of my patients with stress incontinence.

Over the years, we have all seen various waves of surgical innovation, from the noincision urethropexies of the mid-1990s to the laparoscopic techniques prominent later in the decade. Now, more minimally invasive techniques are coming to the fore. At some point, we may even find the Holy Grail. But for the most part, we continue to evolve, examining new approaches until we are forced to reconcile with their limitations.

SAND: It is clear that this is a very exciting time to be treating SUI, with continuing innovation and an increased awareness of the problem by the public. While we all treat these women differently, there is a surprising consensus. We all seem to concur that the operation should be tailored to the individual, considering the relative balance of any concurrent urinary urge incontinence, urethral hypermobility, voiding dysfunction, and the woman’s health and activity level. We all use midurethral slings and periurethral bulking agents in selected women, but still also rely on Burch procedures and bladder-neck slings.

The authors report no financial relationship with any companies whose products are mentioned in this article.

Choosing appropriate surgical interventions is the focus of the second of our 2-part panel on stress urinary incontinence (SUI). The panelists discuss:

• how to weigh the factors that influence choice of technique, including Burch retropubic urethropexy and the various sling operations;
• the challenges of treating “mixed” stress and urge incontinence; and
• when to use bulking agents for intrinsic sphincteric deficiency.

The panelists also share tips on:

• how to help patients accurately describe their symptoms, and
• what issues to review with patients as they consider their options.

Part 1 covered medical therapies such as pelvic floor muscle rehabilitation, occlusive devices, and drugs. (Stress urinary incontinence: A closer look at nonsurgical therapies. OBG Management. 2003;15(9):40-51.)

Review surgical options with the patient

SAND: How do you counsel patients about surgical treatments for stress urinary incontinence?

MYERS: After the initial evaluation and diagnosis, I review the conservative options, and I also offer surgery. At this time, I discuss whether an operation is appropriate.

I work with the patient, going over her diagnosis as well as the different types of operations that are performed. Some patients are fairly well educated about their options, having looked up information on the Internet.

Next I explore whether other types of procedures need to be done concomitantly. For instance, does the patient need abdominal hysterectomy for some other reason? That would prompt me to offer an abdominal approach to the SUI. Do other types of vaginal surgery need to be done? Then I would probably opt for a vaginal approach.

I also look at the patient’s health status. Is she healthy and physically active? Or is she sedentary with comorbidities? In a woman who is a poor surgical candidate, I would consider less invasive procedures or procedures with less operative risk, such as urethral injections or the newer tape slings.

LUBER: When it comes to surgery for urinary incontinence, I like to reinforce the reconstructive nature of the repair, since patients tend to view surgical procedures as definitive. For example, when the uterus and ovaries are removed, they never bother that patient again. Incontinence procedures are different. Their effect is potentially time-limited, so it’s important to reinforce the patient’s understanding of their reconstructive and fallible nature.

At the first surgical consultation, I basically go through an informed consent. I do so again preoperatively, but I think it is a very important initial step for a patient who is considering surgery.

SAND: What if a patient isn’t sure she wants surgery?

LUBER: When a patient asks, “What should I do, Dr. Luber? Should I have an operation?” I like to use the example of standing in front of the refrigerator and asking, “Gee, am I hungry?” If you have to ask, you probably aren’t.

Potential surgical patients should feel extremely comfortable that they have exhausted all the nonsurgical options. Even if they have decided against nonsurgical therapy, they should feel very comfortable with that choice. Then I am confident we can work through any potential problems of surgery.

As for the operation itself, history has demonstrated the irresistible impulse to innovate during surgery for female stress incontinence. Literally hundreds of operations have been described, and dozens are currently in use; this reinforces the supposition that our techniques are imperfect, and the importance of basing what we do upon the available data. The 1997 American Urological Association guidelines are an excellent example. Looking forward, the National Institutes of Health are sponsoring studies comparing, for example, the goldstandard Burch to the goldstandard sling operation. In the next few years, we should have better evidence-based guidance.

Consider patient characteristics when choosing treatment

SAND: How do you select a surgical procedure for a particular patient?

MYERS: Because of all the different variables, I use various treatment arms. Since my institution does a large number of sling procedures, I am very comfortable performing those operations. I still do retropubic urethropexy. I also do the newer vaginal-tape procedures, and I use bulking agents for patients who have a demonstrated sphincter deficiency with no obvious support problems. Basically, I try to tailor my procedure to the patient.

For example, in a woman who requires a total abdominal hysterectomy for fibroids as well as an anti-incontinence procedure, I would do a Burch operation. For a woman who needed a vaginal hysterectomy, I probably would perform a sling procedure.

DAVILA: Ob/Gyns may be a bit unsure how to proceed at this point. For example, we formerly considered the Burch procedure the gold standard against which other procedures should be judged. Although I continue to view it as the standard, the Burch procedure increasingly is overlooked in favor of tension-free slings—due to increased marketing of the latter—for any form of stress incontinence. I think that has led us down a path that is not entirely beneficial for many of our patients.

In contrast to that approach, I use a basic evaluation of the patient to construct a treatment algorithm. In simple terms, 2 factors are taken into account: urethral sphincter function and bladder neck or urethral support. Using those 2 factors, I create a 2×2 table to select patients who do or don’t have urethral hypermobility and who do or don’t have sphincteric deficiency (TABLE).

For example, a patient with hypermobility and normal sphincter function has what we might consider “garden-variety” stress incontinence. Such patients do well with any form of treatment, whether it’s conservative therapy, a vaginal device, or a Burch procedure or tension-free sling.

I am more concerned when the patient has hypermobility with a significant degree of sphincteric deficiency. In recent years, the tendency has been to treat such patients with a tension-free sling. Although the literature is not absolutely clear, the success rate of tension-free slings in a patient with intrinsic sphincteric deficiency (ISD) is not as high as in a woman without ISD.¹ So in these patients, I do a traditional sling.

Atrophy can cause significant urgency and nocturia symptoms.—Dr. Davila

The other 2 groups of patients have no hypermobility. I think most of us would agree that a woman with ISD and no hypermobility would best be treated with a bulking agent such as Contigen (C.R. Bard, Murray Hill, NJ) or Durasphere (Advanced Uroscience, St. Paul, Minn).

I have had good success rates with bulking agents. I do not think current data would support a tension-free sling in these patients.

Finally, there is the patient without hypermobility who has normal sphincter function. These patients do fairly well with conservative therapy, including pelvic floor exercises. They usually have mild forms of stress incontinence to begin with.

TABLE 1

Stress urinary incontinence treatment choices based on urethral support and urethral sphincteric function

Simple method to assess sphincter function

DAVILA: This is the algorithm I tend to follow. It does entail evaluation of the urethral sphincter mechanism, but there are simpler ways to do that than with multi-channel urodynamics. For example, if the patient leaks with a Valsalva maneuver, after voiding, in a supine position, that suggests she has ISD and therefore is likely to have a low-pressure urethra or a low leak-point pressure. Multiple centers have reported on this.^2,3

Role of urethral function in choice of treatment

LUBER: There seems to be 2 schools. The first dichotomizes urethral function to reasonable (“good” urethral function) versus unreasonable (“poor” urethral function or ISD) and selects the operation based on that. Thus, a Burch or supportive operation would be used for good urethral function with hypermobility, and a sling operation would be selected for poor urethral function or ISD.

More recently, some experts have preached an inclusive approach, whereby all patients undergo sling operations. That strategy evolved out of frustration over the difficulty of identifying which patients have poor urethral function. Unfortunately, we lack good long-term data on the potential downside of performing sling procedures on all patients with incontinence. Hopefully, over the next 3 years, the National Institutes of Health data will help clarify whether we need to dichotomize patients in terms of urethral function.

Meanwhile, at our center, we continue to consider urethral function the deciding factor as to whether patients will undergo a gold-standard Burch procedure or a sling. We steer toward a sling procedure when the patient clearly has poor urethral function or ISD. Of course in cases of the fixed immobile and poorly functioning urethra, we also make bulking agents available.

Additional factors in the choice of treatment

SAND: We throw 2 other things into the algorithm at our center: One is detrusor overactivity, which is very important when considering surgical treatment of stress urinary incontinence. The second is voiding function.

Activity level of the patient is an additional measure, as Dr. Myers commented on earlier. I’m not as concerned about age as I am about the patient’s physical activity and expectations for the operation over time. For example, for a woman who is relatively homebound and not physically active and has poor voiding function (underactive detrusor) and prolapse with normal intrinsic urethral function, a Kelly Kennedy procedure at the time of an anterior colporrhaphy may be more appropriate than a Burch procedure.

Detrusor overactivity is important because, in the trial that we performed, the Burch retropubic urethropexy had a 55% objective cure rate of concurrent detrusor overactivity and a 70% subjective cure rate of the symptom of urge urinary incontinence. In contrast, over the last 12 years, the sling procedure has had a resolution rate of between 20% and 28% for recurrent detrusor overactivity. Recent subjective data at 1 year for midurethral slings fall into the same range: 20% to 30% resolution of recurrent urge incontinence.

Another factor is de novo detrusor overactivity. The rate of de novo detrusor overactivity and urge incontinence in our sling patients seems consistently higher, compared with our retropubic urethropexy patients. We all know that the patient with urge incontinence is far more upset about her condition than the patient who has predictable stress incontinence, because urge incontinence can be far more destructive to quality of life. I try to encourage gynecologists to consider this factor.

Voiding function is less clear-cut. Basically, because intrinsic urethral function declines with age, it is not uncommon to see a woman in her 70s or 80s with ISD who also has absent detrusor contractions during voiding studies. The physician can assess this function by ultrasound or urodynamic testing, or by measuring the postvoid residual volume, which usually falls in the range of 100 to 200 mL, especially if no prolapse is present. Thus, even in cases in which I normally would want to do a sling for ISD, I opt against it if the patient has poor voiding function. That’s because the risk of permanent retention may rise as high as 15% to 20% in some of these patients.

Evaluation and treatment of mixed incontinence

DAVILA: I think we all agree that incontinence is easier to address than “hypercontinence” resulting from postoperative urethral obstruction, urinary retention, and irritative voiding symptoms. But what about patients with mixed incontinence? How do you evaluate them? Is there a role for surgical procedures in patients with primary urge incontinence?

I believe in offering all patients both nonsurgical and surgical options.—Dr. Sand

SAND: Many centers offer nonsurgical treatment of mixed incontinence, especially if urge incontinence predominates. But I believe in offering all patients both nonsurgical and surgical options. I end up triaging based on what patients select first, regardless of whether they have pure SUI or mixed symptoms, as long as they have been counseled appropriately about the expected outcomes of the various options.

MYERS: In my practice, I treat the urge symptoms first with anticholinergics or other medications. Then, if the stress incontinence continues, I offer a procedure.

This may be difficult in some cases, such as a patient with severe ISD. It is hard to treat detrusor overactivity when the urethral sphincter is weak, as the woman cannot hold increasing volumes of urine in the bladder.

Thus, I approach these cases by treating the stress incontinence first and then the urgency symptoms if intervention is still necessary—which is a 180-degree shift from my previous statement. In these cases, I treat the ISD first. Then, after the stress incontinence resolves, I offer medications for the urgency.

LUBER: I want to throw a little cold water on surgical treatment of overactive bladder. Clearly, this is an enormous issue. Probably 40% of women who come to my office complaining of urinary incontinence have mixed symptoms or mixed disease as determined by urodynamics. For the doctors out there caring for these patients daily, I think it is important to remember, as Dr. Sand mentioned, that in some cases, anti-incontinence operations can provoke detrusor overactivity in patients who were relatively asymptomatic previously. Dr. Myers’ suggestion that surgery may simply unmask the detrusor overactivity is also possible, of course.

Probably 40% of women who come to my office complaining of urinary incontinence have mixed symptoms.—Dr. Luber

Thus, I think it is reasonable to ask patients reporting mixed symptoms to characterize their urine loss. I usually have them pick a percentage (which isn’t always easy). I ask, “Is your urge incontinence 10%, 50% or 90% of your problem?” If urgency is 90% of the problem and stress incontinence is minimal, then naturally that patient’s care should be focused on the urge incontinence, and vice versa.

It becomes more problematic in the middle, with that 50/50 group. But I’m old-fashioned in that I like to treat the urge incontinence first and get that under control. Of course, in women with poor sphincter function, this distinction becomes more difficult because of the inevitable overlap of symptoms. But this is a small subset of the whole population.

DAVILA: Even if you operate on these patients to correct sphincter function, you must follow them closely. You shouldn’t be saying, “We’ll see you in 6 months.”

In addition, the cofactor of urogenital atrophy should be addressed. Atrophy can cause significant urinary urgency and nocturia symptoms, although most women may not report vaginal atrophy symptoms.⁴ Local estrogen cream at a low dosage can be used pre- and postoperatively without concern about systemic absorption.⁵

Which patients benefit from bulking agents?

SAND: We touched on the use of periurethral injections of bulking agents. How do you determine when bulking agents are appropriate?

MYERS: I use periurethral injections for demonstrated sphincter deficiency. The ideal patient has a supported bladder neck and true sphincter deficiency—for example, patients whose sphincter deficiency is caused by pelvic radiation or significant surgical scarring.

In recent years, I have loosened the guidelines slightly, in that a number of my patients are elderly women with urethral hypermobility who are not healthy enough to undergo a major operation. In these patients, I use a pessary to support the bladder neck before performing an injection, and I make sure the patient understands that she will need to use the pessary even after the injection. I have better results when there is no hypermobility.

LUBER: The concept of ISD as the sole cause of urinary incontinence is less mysterious than it at first appears. In the typical patient with a fixed poorly functioning urethra, a Qtip test will be 0 degrees at rest, and will still be 0 degrees with straining. The patient will leak readily with any kind of provocative maneuver, be it coughing or slight straining. With or without urodynamics, we know that patient’s urethra is not functioning properly. Such a patient, for me, is the ideal candidate for bulking agents.

Unfortunately, bulking agents tend to have short half-lives of around 2 years. Still, you can improve the quality of life of these patients tremendously in that time by periurethrally injecting bulking agents during a very simple office or outpatient visit.

I have had less satisfaction and success using bulking agents in patients with urethral hypermobility, although I do like Dr. Myers’ idea of correcting the hypermobility with an intravaginal support device and then using collagen to improve their urethral coaptation. That’s a nice concept.

Improvements being studied

SAND: Currently, we have 2 injectables approved by the US Food and Drug Administration: collagen and carbon-coated microspheres. Are new agents coming out? Do you expect improvements in the current agents?

DAVILA: The number of bulking agents being studied right now is huge. I think the future will bring one that can be implanted without the need for cystoscopy. A couple of trials under way use a conical urethral template for needle placement, and the injection is performed without cystoscopy. Although we’re a number of years away from having enough data to support the widespread implementation of this approach, the momentum is certainly in that direction.

The half-lives of bulking agents also are increasing. Collagen was an excellent start, but we are moving toward permanence. In addition, most of the agents being studied are simpler to inject than collagen. Biotechnology is coming to the forefront with polymers that are either temperature-sensitive or able to reconfigure themselves over time. Thus, they should serve as a nidus for collagen deposition or remain in place longer, enhancing urethral sphincteric function.

It isn’t clear which agent will take a leading role in the next few years, but a number of them have great promise. This is an exciting time in the management of stress incontinence as we move from invasive procedures such as retropubic urethropexy to minimally invasive surgery—as well as from the operating room to the office.

Radiofrequency technologies

SAND: What do you think about the new radiofrequency technologies being used to create support in periurethral tissues to correct hypermobility? Is there a role for this evolving technology?

LUBER: The concept of developing scar tissue adjacent to the urethra to provide better support underlies much of what we already do surgically. So there is some logic in the use of radiofrequency technologies to accomplish the same thing.

Still, there is the theoretical risk of further denervating the urethra, which is probably already denervated. Having looked at outcome studies for radiofrequency therapy, I think it’s a modality that can be embraced, but that should be done under the auspices of clinical research. Again, I’m old fashioned and am not comfortable integrating untested approaches into routine clinical care until we have adequate evidence of their effectiveness. In caring for incontinence, it is important that this effectiveness be looked at over a reasonable period of time, for example, 48 months.

It is hard to treat detrusor overactivity when the urethral sphincter is weak.—Dr. Myers

DAVILA: I have had some experience with radiofrequency therapy, and the tissue changes it stimulates are fairly impressive. I share your concern about the issue of denervation. In fact, my colleagues and I are hoping to initiate a trial in which we plan to look at pudendal latencies to the urethral sphincter in these patients. As of now, with limited experience, it appears that there is no worsening of urethral sphincter function with the therapy.

Tension-free vaginal tape

SAND: What about other new treatments on the horizon?

DAVILA: Like bulking agents, new minimally invasive surgical techniques are also increasing in number. The advent of the tension-free vaginal tape (TVT), a technique that moved from Sweden to the United States a couple of years ago, truly has revolutionized what we do in anti-incontinence surgery. I think we all can agree that it has changed our practice patterns quite significantly, and the modifications or theoretical improvements by different companies are likely to have a further impact.

Polypropylene mesh appears to be very well received by the body. It doesn’t get rejected or infected at a significant rate, so most physicians are comfortable with it. But I think it has become the surgeon’s preference as to which product works better.

For the Ob/Gyn, the primary issue remains the small yet well-recognized risks of retropubic needle placement, beginning with bladder perforation and including vascular or bowel injury. As a result, many Ob/Gyns have probably been hesitant to perform these procedures.

What the future holds is very exciting: the transobturator approach to surgery for stress incontinence. Instead of bringing the needle superiorly behind the pubic bone, the surgeon maneuvers it laterally beneath the pubic ramus and through the obturator membrane. This is an anti-incontinence procedure a gynecologist can embrace. It may not be necessary to perform cystoscopy afterward because the surgery is nowhere near the bladder.

The French have taken the lead in developing this technique and recently presented approximately 2 years of data.^6,7 A US trial also is being initiated.

LUBER: TVT is billed as a midurethral procedure. However, when you consider where those tapes actually end up after a few months, it probably functions much like a traditional sling. Recent studies are in conflict: Some demonstrate the sling remains at the midurethra while others show that it readily migrates to the bladder neck. So the quest for a less obstructive procedure has not been fulfilled with the TVT.

In fact, in our recent TVT series that Drs. Lukacz and Nager are meticulously following, the voiding time increases and the maximum flow decreases postoperatively in roughly 30% of patients. So it definitely has some obstructive characteristics.

Quest for the Holy Grail continues

LUBER: I think we need to continue to explore these newer, less invasive procedures that offer wonderful potential. At this point, I might employ them in patients who are not able to tolerate the more invasive procedures or who flatly state that they want a less invasive operation. But I am not ready to embrace them as first-line therapy for all of my patients with stress incontinence.

Over the years, we have all seen various waves of surgical innovation, from the noincision urethropexies of the mid-1990s to the laparoscopic techniques prominent later in the decade. Now, more minimally invasive techniques are coming to the fore. At some point, we may even find the Holy Grail. But for the most part, we continue to evolve, examining new approaches until we are forced to reconcile with their limitations.

SAND: It is clear that this is a very exciting time to be treating SUI, with continuing innovation and an increased awareness of the problem by the public. While we all treat these women differently, there is a surprising consensus. We all seem to concur that the operation should be tailored to the individual, considering the relative balance of any concurrent urinary urge incontinence, urethral hypermobility, voiding dysfunction, and the woman’s health and activity level. We all use midurethral slings and periurethral bulking agents in selected women, but still also rely on Burch procedures and bladder-neck slings.

The authors report no financial relationship with any companies whose products are mentioned in this article.

Recent advances have improved the success of vesicovaginal fistula (VVF) repair—a challenge that can test even the most experienced gynecologic surgeon. For example, it now is apparent that some small uncomplicated fistulae respond to conservative treatment. Further, in selected cases, laparoscopic repair can eliminate the need for complicated laparotomy.

In addition, timing of fistula repair no longer requires long periods of observation, and good surgical technique for identifying and repairing bladder injuries at the time of the index surgery can often prevent the development or reduce the severity of VVF.

Vesicovaginal fistula is the most common type of urogenital fistula. Presentation and prognosis vary, depending on location and size of the defect, as well as coexisting factors such as tissue devascularization and previous radiation. However, surgical repair is associated with a high cure rate if it is performed by an experienced surgeon.

Most US cases follow gynecologic surgery

Vesicovaginal fistula was first documented in the mummified remains of Egyptian Queen Henhenit (11th Dynasty, 2050 BC), which were examined in 1923 by Derry.¹ Although the exact incidence of VVF in the United States is unknown, the primary cause is gynecologic surgery, especially hysterectomy. The defect is estimated to occur in 0.01% to 0.04% of gynecologic procedures.

A study of 303 women with genitourinary fistula found that the defect was related to gynecologic surgery in 82% of cases, obstetric events in 8%, radiation therapy in 6%, and trauma or fulguration in 4%.² Rare causes of VVF include lymphogranuloma venereum, tuberculosis, syphilis, bladder stones, and a retained foreign body in the vagina. In rare instances, spontaneous vesicouterine fistulae were reported following uncomplicated vaginal birth after cesarean section.³

Gynecologic surgery may lead to VVF due to extensive dissection between the bladder and the uterus, unrecognized bladder laceration, inappropriate stitch placement, and/or devascularization injury to the tissue planes. Concurrent ureteric involvement has been reported in as many as 10% to 15% of vesicovaginal fistula cases.

In developing countries, vesicovaginal fistulae are far more common and generally related to obstetric factors such as obstructed labor (due to unattended deliveries), small pelvic dimensions, malpresentation, poor uterine contractions, and introital stenosis.

Risk factors. Conditions that may predispose patients to VVF include prior pelvic surgery, a history of pelvic inflammatory disease, pelvic malignancy, endometriosis, infection, diabetes, and anatomic distortion. If these risk factors are present, the patient should be counseled accordingly prior to gynecologic surgery.

Correct classification crucial to surgical success

Proper classification of VVF can help the gynecologic surgeon plan operative intervention. Obstetric vesicovaginal fistulae usually are categorized according to their cause, complexity, and site of obstruction. In contrast, gynecologic fistulae are generally classified as simple or complicated (TABLE).

These levels may have important implications for the surgical approach and prognosis.⁴ For example, simple vesicovaginal fistulae are usually uncomplicated surgical cases with good prognosis. Complicated vesicovaginal fistulae, on the other hand, can challenge even highly practiced and skilled gynecologic surgeons and are associated with a high rate of recurrence.

Women typically present within specific intervals after the various antecedent events (pelvic surgery, childbirth, radiation therapy) with a primary complaint of constant, painless urinary incontinence. If the fistula is related to traumatic childbirth, most patients experience urine leakage within the first 24 to 48 hours. Following pelvic surgery, symptoms usually occur within the first 30 days. In contrast, radiation-induced fistulae develop over a much longer interval secondary to progressive devascularization necrosis, and may present 30 days to 30 years after the antecedent event.

Some patients report exacerbation during physical activities, which can sometimes lead to erroneous diagnosis of uncomplicated stress incontinence. If the fistula is small, intermittent leakage with increased bladder distention or physical activity may be noted.

Other patients may complain of vaginal discharge or hematuria.

If there is concurrent ureteric involvement, the patient may experience constitutional symptoms (such as fever, chills, and flank pain) or even gastrointestinal symptoms.

Physical findings. Any pooling of fluid in the vagina that is noted should be sent for analysis if the diagnosis is unclear. Next, perform a careful speculum exam that allows visualization of the entire anterior vaginal wall to identify the fistula tract (FIGURE 1). In many cases, the fistula is grossly visible.

Determine the location of the fistula in relation to the vaginal apex and bladder trigone and assess the quality of surrounding tissue (eg, presence of inflammation, edema, or infection). Fistulas near the vaginal apex may require a more complicated abdominal approach, and those close to the trigone may be associated with increased risk of ureteral injury during repair.

If the fistula is particularly small, no tract may be apparent. In such cases, bimanual exam with careful palpation of the anterior wall may help isolate the fistula (eg, when there is a surrounding zone of induration).

Office tests. If no fistula is noted despite highly suspicious signs and symptoms and careful examination, a simple office test can be performed. Using a catheter, fill the bladder with a dyed solution such as normal saline with indigo carmine and repeat the pelvic exam with a half-speculum to visualize the anterior wall. Ask the patient to cough and bear down, and identify the fistula by visualizing urine leakage.

If this test fails to locate the fistula, insert a tampon and ask the patient to perform 10 to 15 minutes of exertional maneuvers, including stair climbing and jumping in place. Then remove the tampon. Visualization of dye beyond the most distal edge of the tampon confirms the presence of a fistula.

A variation of this technique is the double-dye test: Give the patient oral phenazopyridine (Pyridium), fill the bladder with the blue-tinted solution, and insert a tampon. The presence of blue staining suggests vesicovaginal or urethrovaginal fistula, while red staining (Pyridium) suggests ureterovaginal fistula.

Other testing. Further assessment is recommended to rule out concurrent pathology and formulate an appropriate treatment plan. Routine testing should include a urinalysis and culture to exclude coexisting urinary tract infection, an electrolyte panel to evaluate renal function, and a complete blood cell count to rule out systemic infection.

Cystoscopy should be performed to visualize the fistulous tract, assess its location in relation to the ureters and trigone, assure bilateral ureteral patency, and exclude the presence of a foreign body or suture in the bladder.

In patients with a history of urogenital malignancy, biopsy of the fistula tract and urine cytology is warranted.

Comparable success rates have been reported for early and late repair of surgery-induced fistulae.

Radiologic studies are recommended prior to surgical repair of a vesicovaginal fistula to fully assess the defect and exclude the presence of multiple fistulae. An intravenous pyelogram is helpful to exclude concurrent ureterovaginal fistulae or ureteral obstruction. A targeted fistulogram may be indicated if conservative therapy is planned, including expectant management, continuous bladder drainage, fulguration, or fibrin occlusion.

FIGURE 1 Vesicovaginal fistula

Pelvic cross section depicting high vesicovaginal fistula.TABLE

Classification of vesicovaginal fistulae¹⁷

Indications for conservative management

Because spontaneous closure is uncommon, symptomatic VVF merits treatment. Appropriate therapy depends on various factors, including fistula size and location, timing from the antecedent event, severity of symptoms, quality of surrounding tissue, and clinician experience and surgical skills.

Occasionally, a fistula heals following prolonged bladder drainage through a transurethral or suprapubic catheter—provided it is diagnosed within a few days of surgery. Zimmern⁵ recommends a conservative approach to small fistulae if the patient’s complaints of urinary incontinence are resolved with insertion of a Foley catheter. In this case, bladder drainage should be continued for 3 weeks, followed by reevaluation of the fistula. If the fistula has diminished in size, an additional 3 weeks of catheter drainage is associated with a high rate of spontaneous closure; if there is no change, the fistula is unlikely to resolve spontaneously.⁵

Varying success rates have been reported for conservative management, ranging from 2% to 80%.^4,6 The chances of success are apparently greater if the fistula is:

• diagnosed within 7 days of the index surgery,
• less than 1 cm in size,
• simple, without associated carcinoma or radiation, and
• subject to at least 4 weeks of constant bladder drainage.

Persistent, large, or complex fistulae are best treated surgically.

Indications for surgical management

The basic principles of fistula closure apply. They are:

• adequate exposure,
• good hemostasis,
• wide mobilization of the bladder and vagina,
• resection of devascularized tissue,
• removal of any foreign bodies,
• tension-free closure,
• nonopposition of suture lines,
• confirmation of a water-tight seal on bladder closure, and
• bladder drainage for 10 to 14 days following the repair.

Timing of the repair has been the subject of controversy and can pose a dilemma to physician and patient alike. Traditionally, an interval of 3 months was recommended between the index surgery and fistula repair, with a delay of up to 1 year when the fistula was radiation-induced. However, little data support these recommendations.

Today most experts recommend an individualized approach, delaying the surgery until inflammation and infection of the surrounding tissue have resolved. The use of estrogen, antibiotics, or steroids to facilitate healing during this period also has been recommended.⁷ Comparable success rates have been reported for early and late repair of surgery-induced fistulae based on these principles.^8-10

Vaginal approach. Most vesicovaginal fistulae can be surgically corrected using a vaginal approach. Traditionally, a Latzko partial colpocleisis or fistulectomy with flap-splitting closure has been advocated.

Debate continues about whether resection of the fistulous tract is necessary. Some experts believe that wide resection increases the size of the fistula and, therefore, the risk of recurrence. They also maintain that the fibrous tissue surrounding the fistula helps to reinforce the surgical repair. Proponents of fistulectomy counter that resection of the fistula and exposure of healthy tissue optimizes wound healing and improves surgical success rates. Comparable success has been reported for both techniques.^11,12

We prefer an individualized approach, with minimal resection of the fistulous tract to simplify the procedure and minimize associated complications, including recurrence.

• Latzko partial colpocleisis. This technique, first reported in 1942, remains a common procedure, with success rates of 90% to 100%.¹³ Advantages include a short operative time, low intraoperative and postoperative morbidity, and low risk of ureteral injury.
• Fistulectomy technique. Alternatively, to perform fistulectomy with a flap-splitting closure, begin by resecting the fistulous tract to expose healthy tissue at the wound margins. Then close the defect in a multilayer fashion, beginning with the bladder mucosa, bladder serosa, pubocervical fascia, and vaginal mucosa. Be careful to avoid tension on suture lines. In addition, create a fascial flap to prevent opposition of the incision planes and reduce the risk of recurrence.
• Grafts. In cases with a high risk of recurrence, such as complex or large fistulae, a Martius fat-pad graft should be interposed between the closure layers to promote vascularization and reduce the risk of recurrence.¹⁴ Placement of a cadaveric biomaterial graft also has been reported, reducing the need for complicated flap procedures.¹⁵

Abdominal approach. Although most vesicovaginal fistulae can be surgically corrected via the vaginal approach, the abdominal route may be preferred when the fistula is high and inaccessible, large and complex, multiple in number, or when there is concurrent uterine or bowel involvement or a need for ureteral reimplantation. The abdominal approach may be facilitated by cystoscopically guided placement of a catheter through the fistulous tract to assist in subsequent identification and dissection.

To begin, make a vertical skin incision to optimize visualization and allow mobilization of an omental flap, if necessary. Expose the bladder and perform a high extraperitoneal cystotomy to visualize the fistulous tract. Place ureteral stents if the fistula is in close proximity to the ureteral orifice.

Extend the bladder incision to the fistulous tract and completely excise it following mobilization of the vagina. Then close the vagina and bladder with interrupted, delayed absorbable suture in a double layer.

Transpose an omental flap between the vaginal and bladder incisions to promote vascularization, minimize opposition of suture lines, and reduce the risk of recurrence (FIGURE 2).

Laparoscopic approach. A similar laparoscopic repair has been reported with comparable results, but requires advanced skills with endoscopic suturing and knot tying (FIGURE 3).¹⁶

FIGURE 2 Abdominal repair

Abdominal repair of vesicovaginal fistula, with closure of bladder defect and posterior cystotomy and separate closure of vaginal defect. Note the omental flap pictured in the insert.

FIGURE 3 Laparoscopic repair

Laparoscopic repair of vesicovaginal fistula.The authors report no financial relationship with any companies whose products are mentioned in this article.

Recent advances have improved the success of vesicovaginal fistula (VVF) repair—a challenge that can test even the most experienced gynecologic surgeon. For example, it now is apparent that some small uncomplicated fistulae respond to conservative treatment. Further, in selected cases, laparoscopic repair can eliminate the need for complicated laparotomy.

In addition, timing of fistula repair no longer requires long periods of observation, and good surgical technique for identifying and repairing bladder injuries at the time of the index surgery can often prevent the development or reduce the severity of VVF.

Vesicovaginal fistula is the most common type of urogenital fistula. Presentation and prognosis vary, depending on location and size of the defect, as well as coexisting factors such as tissue devascularization and previous radiation. However, surgical repair is associated with a high cure rate if it is performed by an experienced surgeon.

Most US cases follow gynecologic surgery

Vesicovaginal fistula was first documented in the mummified remains of Egyptian Queen Henhenit (11th Dynasty, 2050 BC), which were examined in 1923 by Derry.¹ Although the exact incidence of VVF in the United States is unknown, the primary cause is gynecologic surgery, especially hysterectomy. The defect is estimated to occur in 0.01% to 0.04% of gynecologic procedures.

A study of 303 women with genitourinary fistula found that the defect was related to gynecologic surgery in 82% of cases, obstetric events in 8%, radiation therapy in 6%, and trauma or fulguration in 4%.² Rare causes of VVF include lymphogranuloma venereum, tuberculosis, syphilis, bladder stones, and a retained foreign body in the vagina. In rare instances, spontaneous vesicouterine fistulae were reported following uncomplicated vaginal birth after cesarean section.³

Gynecologic surgery may lead to VVF due to extensive dissection between the bladder and the uterus, unrecognized bladder laceration, inappropriate stitch placement, and/or devascularization injury to the tissue planes. Concurrent ureteric involvement has been reported in as many as 10% to 15% of vesicovaginal fistula cases.

In developing countries, vesicovaginal fistulae are far more common and generally related to obstetric factors such as obstructed labor (due to unattended deliveries), small pelvic dimensions, malpresentation, poor uterine contractions, and introital stenosis.

Risk factors. Conditions that may predispose patients to VVF include prior pelvic surgery, a history of pelvic inflammatory disease, pelvic malignancy, endometriosis, infection, diabetes, and anatomic distortion. If these risk factors are present, the patient should be counseled accordingly prior to gynecologic surgery.

Correct classification crucial to surgical success

Proper classification of VVF can help the gynecologic surgeon plan operative intervention. Obstetric vesicovaginal fistulae usually are categorized according to their cause, complexity, and site of obstruction. In contrast, gynecologic fistulae are generally classified as simple or complicated (TABLE).

These levels may have important implications for the surgical approach and prognosis.⁴ For example, simple vesicovaginal fistulae are usually uncomplicated surgical cases with good prognosis. Complicated vesicovaginal fistulae, on the other hand, can challenge even highly practiced and skilled gynecologic surgeons and are associated with a high rate of recurrence.

Women typically present within specific intervals after the various antecedent events (pelvic surgery, childbirth, radiation therapy) with a primary complaint of constant, painless urinary incontinence. If the fistula is related to traumatic childbirth, most patients experience urine leakage within the first 24 to 48 hours. Following pelvic surgery, symptoms usually occur within the first 30 days. In contrast, radiation-induced fistulae develop over a much longer interval secondary to progressive devascularization necrosis, and may present 30 days to 30 years after the antecedent event.

Some patients report exacerbation during physical activities, which can sometimes lead to erroneous diagnosis of uncomplicated stress incontinence. If the fistula is small, intermittent leakage with increased bladder distention or physical activity may be noted.

Other patients may complain of vaginal discharge or hematuria.

If there is concurrent ureteric involvement, the patient may experience constitutional symptoms (such as fever, chills, and flank pain) or even gastrointestinal symptoms.

Physical findings. Any pooling of fluid in the vagina that is noted should be sent for analysis if the diagnosis is unclear. Next, perform a careful speculum exam that allows visualization of the entire anterior vaginal wall to identify the fistula tract (FIGURE 1). In many cases, the fistula is grossly visible.

Determine the location of the fistula in relation to the vaginal apex and bladder trigone and assess the quality of surrounding tissue (eg, presence of inflammation, edema, or infection). Fistulas near the vaginal apex may require a more complicated abdominal approach, and those close to the trigone may be associated with increased risk of ureteral injury during repair.

If the fistula is particularly small, no tract may be apparent. In such cases, bimanual exam with careful palpation of the anterior wall may help isolate the fistula (eg, when there is a surrounding zone of induration).

Office tests. If no fistula is noted despite highly suspicious signs and symptoms and careful examination, a simple office test can be performed. Using a catheter, fill the bladder with a dyed solution such as normal saline with indigo carmine and repeat the pelvic exam with a half-speculum to visualize the anterior wall. Ask the patient to cough and bear down, and identify the fistula by visualizing urine leakage.

If this test fails to locate the fistula, insert a tampon and ask the patient to perform 10 to 15 minutes of exertional maneuvers, including stair climbing and jumping in place. Then remove the tampon. Visualization of dye beyond the most distal edge of the tampon confirms the presence of a fistula.

A variation of this technique is the double-dye test: Give the patient oral phenazopyridine (Pyridium), fill the bladder with the blue-tinted solution, and insert a tampon. The presence of blue staining suggests vesicovaginal or urethrovaginal fistula, while red staining (Pyridium) suggests ureterovaginal fistula.

Other testing. Further assessment is recommended to rule out concurrent pathology and formulate an appropriate treatment plan. Routine testing should include a urinalysis and culture to exclude coexisting urinary tract infection, an electrolyte panel to evaluate renal function, and a complete blood cell count to rule out systemic infection.

Cystoscopy should be performed to visualize the fistulous tract, assess its location in relation to the ureters and trigone, assure bilateral ureteral patency, and exclude the presence of a foreign body or suture in the bladder.

In patients with a history of urogenital malignancy, biopsy of the fistula tract and urine cytology is warranted.

Comparable success rates have been reported for early and late repair of surgery-induced fistulae.

Radiologic studies are recommended prior to surgical repair of a vesicovaginal fistula to fully assess the defect and exclude the presence of multiple fistulae. An intravenous pyelogram is helpful to exclude concurrent ureterovaginal fistulae or ureteral obstruction. A targeted fistulogram may be indicated if conservative therapy is planned, including expectant management, continuous bladder drainage, fulguration, or fibrin occlusion.

FIGURE 1 Vesicovaginal fistula

Pelvic cross section depicting high vesicovaginal fistula.TABLE

Classification of vesicovaginal fistulae¹⁷

Indications for conservative management

Because spontaneous closure is uncommon, symptomatic VVF merits treatment. Appropriate therapy depends on various factors, including fistula size and location, timing from the antecedent event, severity of symptoms, quality of surrounding tissue, and clinician experience and surgical skills.

Occasionally, a fistula heals following prolonged bladder drainage through a transurethral or suprapubic catheter—provided it is diagnosed within a few days of surgery. Zimmern⁵ recommends a conservative approach to small fistulae if the patient’s complaints of urinary incontinence are resolved with insertion of a Foley catheter. In this case, bladder drainage should be continued for 3 weeks, followed by reevaluation of the fistula. If the fistula has diminished in size, an additional 3 weeks of catheter drainage is associated with a high rate of spontaneous closure; if there is no change, the fistula is unlikely to resolve spontaneously.⁵

Varying success rates have been reported for conservative management, ranging from 2% to 80%.^4,6 The chances of success are apparently greater if the fistula is:

• diagnosed within 7 days of the index surgery,
• less than 1 cm in size,
• simple, without associated carcinoma or radiation, and
• subject to at least 4 weeks of constant bladder drainage.

Persistent, large, or complex fistulae are best treated surgically.

Indications for surgical management

The basic principles of fistula closure apply. They are:

• adequate exposure,
• good hemostasis,
• wide mobilization of the bladder and vagina,
• resection of devascularized tissue,
• removal of any foreign bodies,
• tension-free closure,
• nonopposition of suture lines,
• confirmation of a water-tight seal on bladder closure, and
• bladder drainage for 10 to 14 days following the repair.

Timing of the repair has been the subject of controversy and can pose a dilemma to physician and patient alike. Traditionally, an interval of 3 months was recommended between the index surgery and fistula repair, with a delay of up to 1 year when the fistula was radiation-induced. However, little data support these recommendations.

Today most experts recommend an individualized approach, delaying the surgery until inflammation and infection of the surrounding tissue have resolved. The use of estrogen, antibiotics, or steroids to facilitate healing during this period also has been recommended.⁷ Comparable success rates have been reported for early and late repair of surgery-induced fistulae based on these principles.^8-10

Vaginal approach. Most vesicovaginal fistulae can be surgically corrected using a vaginal approach. Traditionally, a Latzko partial colpocleisis or fistulectomy with flap-splitting closure has been advocated.

Debate continues about whether resection of the fistulous tract is necessary. Some experts believe that wide resection increases the size of the fistula and, therefore, the risk of recurrence. They also maintain that the fibrous tissue surrounding the fistula helps to reinforce the surgical repair. Proponents of fistulectomy counter that resection of the fistula and exposure of healthy tissue optimizes wound healing and improves surgical success rates. Comparable success has been reported for both techniques.^11,12

We prefer an individualized approach, with minimal resection of the fistulous tract to simplify the procedure and minimize associated complications, including recurrence.

• Latzko partial colpocleisis. This technique, first reported in 1942, remains a common procedure, with success rates of 90% to 100%.¹³ Advantages include a short operative time, low intraoperative and postoperative morbidity, and low risk of ureteral injury.
• Fistulectomy technique. Alternatively, to perform fistulectomy with a flap-splitting closure, begin by resecting the fistulous tract to expose healthy tissue at the wound margins. Then close the defect in a multilayer fashion, beginning with the bladder mucosa, bladder serosa, pubocervical fascia, and vaginal mucosa. Be careful to avoid tension on suture lines. In addition, create a fascial flap to prevent opposition of the incision planes and reduce the risk of recurrence.
• Grafts. In cases with a high risk of recurrence, such as complex or large fistulae, a Martius fat-pad graft should be interposed between the closure layers to promote vascularization and reduce the risk of recurrence.¹⁴ Placement of a cadaveric biomaterial graft also has been reported, reducing the need for complicated flap procedures.¹⁵

Abdominal approach. Although most vesicovaginal fistulae can be surgically corrected via the vaginal approach, the abdominal route may be preferred when the fistula is high and inaccessible, large and complex, multiple in number, or when there is concurrent uterine or bowel involvement or a need for ureteral reimplantation. The abdominal approach may be facilitated by cystoscopically guided placement of a catheter through the fistulous tract to assist in subsequent identification and dissection.

To begin, make a vertical skin incision to optimize visualization and allow mobilization of an omental flap, if necessary. Expose the bladder and perform a high extraperitoneal cystotomy to visualize the fistulous tract. Place ureteral stents if the fistula is in close proximity to the ureteral orifice.

Extend the bladder incision to the fistulous tract and completely excise it following mobilization of the vagina. Then close the vagina and bladder with interrupted, delayed absorbable suture in a double layer.

Transpose an omental flap between the vaginal and bladder incisions to promote vascularization, minimize opposition of suture lines, and reduce the risk of recurrence (FIGURE 2).

Laparoscopic approach. A similar laparoscopic repair has been reported with comparable results, but requires advanced skills with endoscopic suturing and knot tying (FIGURE 3).¹⁶

FIGURE 2 Abdominal repair

Abdominal repair of vesicovaginal fistula, with closure of bladder defect and posterior cystotomy and separate closure of vaginal defect. Note the omental flap pictured in the insert.

FIGURE 3 Laparoscopic repair

Laparoscopic repair of vesicovaginal fistula.The authors report no financial relationship with any companies whose products are mentioned in this article.

Recent advances have improved the success of vesicovaginal fistula (VVF) repair—a challenge that can test even the most experienced gynecologic surgeon. For example, it now is apparent that some small uncomplicated fistulae respond to conservative treatment. Further, in selected cases, laparoscopic repair can eliminate the need for complicated laparotomy.

In addition, timing of fistula repair no longer requires long periods of observation, and good surgical technique for identifying and repairing bladder injuries at the time of the index surgery can often prevent the development or reduce the severity of VVF.

Vesicovaginal fistula is the most common type of urogenital fistula. Presentation and prognosis vary, depending on location and size of the defect, as well as coexisting factors such as tissue devascularization and previous radiation. However, surgical repair is associated with a high cure rate if it is performed by an experienced surgeon.

Most US cases follow gynecologic surgery

Vesicovaginal fistula was first documented in the mummified remains of Egyptian Queen Henhenit (11th Dynasty, 2050 BC), which were examined in 1923 by Derry.¹ Although the exact incidence of VVF in the United States is unknown, the primary cause is gynecologic surgery, especially hysterectomy. The defect is estimated to occur in 0.01% to 0.04% of gynecologic procedures.

A study of 303 women with genitourinary fistula found that the defect was related to gynecologic surgery in 82% of cases, obstetric events in 8%, radiation therapy in 6%, and trauma or fulguration in 4%.² Rare causes of VVF include lymphogranuloma venereum, tuberculosis, syphilis, bladder stones, and a retained foreign body in the vagina. In rare instances, spontaneous vesicouterine fistulae were reported following uncomplicated vaginal birth after cesarean section.³

Gynecologic surgery may lead to VVF due to extensive dissection between the bladder and the uterus, unrecognized bladder laceration, inappropriate stitch placement, and/or devascularization injury to the tissue planes. Concurrent ureteric involvement has been reported in as many as 10% to 15% of vesicovaginal fistula cases.

In developing countries, vesicovaginal fistulae are far more common and generally related to obstetric factors such as obstructed labor (due to unattended deliveries), small pelvic dimensions, malpresentation, poor uterine contractions, and introital stenosis.

Risk factors. Conditions that may predispose patients to VVF include prior pelvic surgery, a history of pelvic inflammatory disease, pelvic malignancy, endometriosis, infection, diabetes, and anatomic distortion. If these risk factors are present, the patient should be counseled accordingly prior to gynecologic surgery.

Correct classification crucial to surgical success

Proper classification of VVF can help the gynecologic surgeon plan operative intervention. Obstetric vesicovaginal fistulae usually are categorized according to their cause, complexity, and site of obstruction. In contrast, gynecologic fistulae are generally classified as simple or complicated (TABLE).

These levels may have important implications for the surgical approach and prognosis.⁴ For example, simple vesicovaginal fistulae are usually uncomplicated surgical cases with good prognosis. Complicated vesicovaginal fistulae, on the other hand, can challenge even highly practiced and skilled gynecologic surgeons and are associated with a high rate of recurrence.

Women typically present within specific intervals after the various antecedent events (pelvic surgery, childbirth, radiation therapy) with a primary complaint of constant, painless urinary incontinence. If the fistula is related to traumatic childbirth, most patients experience urine leakage within the first 24 to 48 hours. Following pelvic surgery, symptoms usually occur within the first 30 days. In contrast, radiation-induced fistulae develop over a much longer interval secondary to progressive devascularization necrosis, and may present 30 days to 30 years after the antecedent event.

Some patients report exacerbation during physical activities, which can sometimes lead to erroneous diagnosis of uncomplicated stress incontinence. If the fistula is small, intermittent leakage with increased bladder distention or physical activity may be noted.

Other patients may complain of vaginal discharge or hematuria.

If there is concurrent ureteric involvement, the patient may experience constitutional symptoms (such as fever, chills, and flank pain) or even gastrointestinal symptoms.

Physical findings. Any pooling of fluid in the vagina that is noted should be sent for analysis if the diagnosis is unclear. Next, perform a careful speculum exam that allows visualization of the entire anterior vaginal wall to identify the fistula tract (FIGURE 1). In many cases, the fistula is grossly visible.

Determine the location of the fistula in relation to the vaginal apex and bladder trigone and assess the quality of surrounding tissue (eg, presence of inflammation, edema, or infection). Fistulas near the vaginal apex may require a more complicated abdominal approach, and those close to the trigone may be associated with increased risk of ureteral injury during repair.

If the fistula is particularly small, no tract may be apparent. In such cases, bimanual exam with careful palpation of the anterior wall may help isolate the fistula (eg, when there is a surrounding zone of induration).

Office tests. If no fistula is noted despite highly suspicious signs and symptoms and careful examination, a simple office test can be performed. Using a catheter, fill the bladder with a dyed solution such as normal saline with indigo carmine and repeat the pelvic exam with a half-speculum to visualize the anterior wall. Ask the patient to cough and bear down, and identify the fistula by visualizing urine leakage.

If this test fails to locate the fistula, insert a tampon and ask the patient to perform 10 to 15 minutes of exertional maneuvers, including stair climbing and jumping in place. Then remove the tampon. Visualization of dye beyond the most distal edge of the tampon confirms the presence of a fistula.

A variation of this technique is the double-dye test: Give the patient oral phenazopyridine (Pyridium), fill the bladder with the blue-tinted solution, and insert a tampon. The presence of blue staining suggests vesicovaginal or urethrovaginal fistula, while red staining (Pyridium) suggests ureterovaginal fistula.

Other testing. Further assessment is recommended to rule out concurrent pathology and formulate an appropriate treatment plan. Routine testing should include a urinalysis and culture to exclude coexisting urinary tract infection, an electrolyte panel to evaluate renal function, and a complete blood cell count to rule out systemic infection.

Cystoscopy should be performed to visualize the fistulous tract, assess its location in relation to the ureters and trigone, assure bilateral ureteral patency, and exclude the presence of a foreign body or suture in the bladder.

In patients with a history of urogenital malignancy, biopsy of the fistula tract and urine cytology is warranted.

Comparable success rates have been reported for early and late repair of surgery-induced fistulae.

Radiologic studies are recommended prior to surgical repair of a vesicovaginal fistula to fully assess the defect and exclude the presence of multiple fistulae. An intravenous pyelogram is helpful to exclude concurrent ureterovaginal fistulae or ureteral obstruction. A targeted fistulogram may be indicated if conservative therapy is planned, including expectant management, continuous bladder drainage, fulguration, or fibrin occlusion.

FIGURE 1 Vesicovaginal fistula

Pelvic cross section depicting high vesicovaginal fistula.TABLE

Classification of vesicovaginal fistulae¹⁷

Indications for conservative management

Because spontaneous closure is uncommon, symptomatic VVF merits treatment. Appropriate therapy depends on various factors, including fistula size and location, timing from the antecedent event, severity of symptoms, quality of surrounding tissue, and clinician experience and surgical skills.

Occasionally, a fistula heals following prolonged bladder drainage through a transurethral or suprapubic catheter—provided it is diagnosed within a few days of surgery. Zimmern⁵ recommends a conservative approach to small fistulae if the patient’s complaints of urinary incontinence are resolved with insertion of a Foley catheter. In this case, bladder drainage should be continued for 3 weeks, followed by reevaluation of the fistula. If the fistula has diminished in size, an additional 3 weeks of catheter drainage is associated with a high rate of spontaneous closure; if there is no change, the fistula is unlikely to resolve spontaneously.⁵

Varying success rates have been reported for conservative management, ranging from 2% to 80%.^4,6 The chances of success are apparently greater if the fistula is:

• diagnosed within 7 days of the index surgery,
• less than 1 cm in size,
• simple, without associated carcinoma or radiation, and
• subject to at least 4 weeks of constant bladder drainage.

Persistent, large, or complex fistulae are best treated surgically.

Indications for surgical management

The basic principles of fistula closure apply. They are:

• adequate exposure,
• good hemostasis,
• wide mobilization of the bladder and vagina,
• resection of devascularized tissue,
• removal of any foreign bodies,
• tension-free closure,
• nonopposition of suture lines,
• confirmation of a water-tight seal on bladder closure, and
• bladder drainage for 10 to 14 days following the repair.

Timing of the repair has been the subject of controversy and can pose a dilemma to physician and patient alike. Traditionally, an interval of 3 months was recommended between the index surgery and fistula repair, with a delay of up to 1 year when the fistula was radiation-induced. However, little data support these recommendations.

Today most experts recommend an individualized approach, delaying the surgery until inflammation and infection of the surrounding tissue have resolved. The use of estrogen, antibiotics, or steroids to facilitate healing during this period also has been recommended.⁷ Comparable success rates have been reported for early and late repair of surgery-induced fistulae based on these principles.^8-10

Vaginal approach. Most vesicovaginal fistulae can be surgically corrected using a vaginal approach. Traditionally, a Latzko partial colpocleisis or fistulectomy with flap-splitting closure has been advocated.

Debate continues about whether resection of the fistulous tract is necessary. Some experts believe that wide resection increases the size of the fistula and, therefore, the risk of recurrence. They also maintain that the fibrous tissue surrounding the fistula helps to reinforce the surgical repair. Proponents of fistulectomy counter that resection of the fistula and exposure of healthy tissue optimizes wound healing and improves surgical success rates. Comparable success has been reported for both techniques.^11,12

We prefer an individualized approach, with minimal resection of the fistulous tract to simplify the procedure and minimize associated complications, including recurrence.

• Latzko partial colpocleisis. This technique, first reported in 1942, remains a common procedure, with success rates of 90% to 100%.¹³ Advantages include a short operative time, low intraoperative and postoperative morbidity, and low risk of ureteral injury.
• Fistulectomy technique. Alternatively, to perform fistulectomy with a flap-splitting closure, begin by resecting the fistulous tract to expose healthy tissue at the wound margins. Then close the defect in a multilayer fashion, beginning with the bladder mucosa, bladder serosa, pubocervical fascia, and vaginal mucosa. Be careful to avoid tension on suture lines. In addition, create a fascial flap to prevent opposition of the incision planes and reduce the risk of recurrence.
• Grafts. In cases with a high risk of recurrence, such as complex or large fistulae, a Martius fat-pad graft should be interposed between the closure layers to promote vascularization and reduce the risk of recurrence.¹⁴ Placement of a cadaveric biomaterial graft also has been reported, reducing the need for complicated flap procedures.¹⁵

Abdominal approach. Although most vesicovaginal fistulae can be surgically corrected via the vaginal approach, the abdominal route may be preferred when the fistula is high and inaccessible, large and complex, multiple in number, or when there is concurrent uterine or bowel involvement or a need for ureteral reimplantation. The abdominal approach may be facilitated by cystoscopically guided placement of a catheter through the fistulous tract to assist in subsequent identification and dissection.

To begin, make a vertical skin incision to optimize visualization and allow mobilization of an omental flap, if necessary. Expose the bladder and perform a high extraperitoneal cystotomy to visualize the fistulous tract. Place ureteral stents if the fistula is in close proximity to the ureteral orifice.

Extend the bladder incision to the fistulous tract and completely excise it following mobilization of the vagina. Then close the vagina and bladder with interrupted, delayed absorbable suture in a double layer.

Transpose an omental flap between the vaginal and bladder incisions to promote vascularization, minimize opposition of suture lines, and reduce the risk of recurrence (FIGURE 2).

Laparoscopic approach. A similar laparoscopic repair has been reported with comparable results, but requires advanced skills with endoscopic suturing and knot tying (FIGURE 3).¹⁶

FIGURE 2 Abdominal repair

Abdominal repair of vesicovaginal fistula, with closure of bladder defect and posterior cystotomy and separate closure of vaginal defect. Note the omental flap pictured in the insert.

FIGURE 3 Laparoscopic repair

Laparoscopic repair of vesicovaginal fistula.The authors report no financial relationship with any companies whose products are mentioned in this article.

Potential complications associated with passing needle carriers through the retropubic space are eliminated, and cystoscopy is not routinely required with the use of a transobturator sling.

Although it is effective and easy to perform,^1-6 retropubic placement of suburethral tension-free vaginal tape (TVT) for the treatment of stress urinary incontinence has been associated with a number of bowel, vascular, nerve, and bladder injuries (TABLE).^7-13

Such complications appear to be related to the unique upward vaginal passage of the metallic sling trocars through the retropubic space. Newer slings eliminate the upward approach, but still require routine cystoscopy to confirm an intact bladder and urethra.

A new tension-free suburethral sling addresses these shortcomings using an innovative transobturator route.¹⁴ In the new procedure, the surgeon uses needle passers to run the sling from one obturator foramen to the other. The perineal approach reproduces the natural suspension of the urethral fascia while preserving an intact retropubic space (FIGURE 1).

TABLE

Advantages of the transobturator sling

FIGURE 1 Suburethral slings: Retropubic and transobturator pathways

Traditional suburethral tension-free slings require the needle passers and sling to be placed through the retropubic space.

The newer transobturator sling uses a perineal approach. The needle passer and sling are passed from one obturator foramen to the other, preserving an intact retropubic space.

What does ‘tension-free’ mean?

Tension-free slings are used to treat stress urinary incontinence caused by urethral hypermobility and intrinsic sphincter deficiency. In this approach, a synthetic transvaginal suburethral sling is placed through the retropubic space without using suspension sutures. The sling is held in place by the friction between the mesh and the tissue canals created by the metallic needle passers. Scar tissue later fixes the mesh, preventing migration.

Short-term efficacy of the Monarc transobturator sling is similar to that of the SPARC and tension-free vaginal slings.

Because the sling is not anchored to the pubic bone, ligaments, or rectus fascia, it is considered “free of tension.” The result is a midcomplex urethral support that limits urethral descent, improves the stabilization mechanism generated by pubourethral ligaments and levator ani muscles, and reinforces support of the backboard vaginal hammock.

A tension-free sling designed to reduce injury

Since its introduction in the mid 1990s, retropubic placement of suburethral tension-free tape has continued to gain in popularity.^15-22 The technique has several advantages: It is simple to perform under local, regional, or general anesthesia, and has proved to be a safe treatment for stress urinary incontinence, with minimal complications in experienced hands. Still, injuries have occurred^7-13 —likely due to the blind passing of metal trocars from the vagina upward through the retropubic space.^9,23

Downward placement introduced. In an effort to reduce these complications, tension-free sling systems that rely on suprapubic, downward needle-carrier placement through the retropubic space were developed, such as the SPARC Female Sling System (American Medical Systems, Minnetonka, Minn), introduced in 2001.²⁴ The manufacturer of the traditional TVT (Gynecare, a division of Ethicon, Somerville, NJ) also recently introduced suprapubic needle passers. However, because these slings still require passage through the retropubic space, their use may lead to vascular, bowel, and bladder injury. Routine cystoscopy is therefore required.

The transobturator sling. In the Netherlands in 1998, Nickel et al²⁵ reported a successful sling procedure using a polyester ribbon passed through the obturator foramen and around the urethra for treatment of refractory urethral sphincter incompetence in female dogs. In France in 2001, Delorme¹⁴ introduced the transobturator sling procedure in humans. Dargent et al²⁶ then performed the operation in 71 patients using a technique inspired by Delorme, and found the shortterm results similar to those of the TVT.

The Monarc transobturator sling (American Medical Systems), introduced in Europe in January 2003, has been used successfully in more than 1,000 procedures ( FIGURE 2). This new system offers significant technical improvements over the original transobturator sling devices.

The Monarc transobturator sling, introduced in Europe in January 2003, has been used successfully in more than 1,000 procedures.

Specifically, the Monarc system simplifies rotation of the needle passer during insertion and extraction around the inferior aspect of the ischiopubic ramus. The 3-mm–diameter passers are specifically designed for right-side or left-side use. They are attached to fixed handles to create a natural wrist rotation. The sling connectors, meanwhile, facilitate rapid, effortless, and secure mesh placement and fixation.

FIGURE 2 Monarc transobturator sling system

The Monarc system consists of 2 stainless steel helical-shaped needle passers and a 1-cm by 35-cm polypropylene sling mesh with a protected sheath, attached connectors, and a reabsorbable tensioning suture.

Easy to learn and perform

Anesthesia may be local, regional, or general, and prophylactic antibiotics are routinely given. FIGURES 3 through 6 offer a detailed description of how to surgically place the Monarc transobturator sling for treatment of stress urinary incontinence. What follows is a brief overview:

After making a small vertical incision along the anterior vaginal mucosa, use a finger to locate the upper-inner corner of the obturator foramen—the safe zone for needle insertion. You will incise the skin at this point and introduce the needle tip perpendicularly. Rotate the needle, with the tip following the posterior surface of the pubic ramus, until the tip exits the vaginal incision. Repeat this process on the other side.

Attach the sling and its plastic sheath, then draw both out through the skin incisions by pulling back on the needle passers. Cut the mesh, adjust the tension, and close the incisions.

A Foley catheter and vaginal packing with metronidazole gel may be used at the surgeon’s discretion.

Route minimizes anatomical hazards. The pathway described ensures that there tropubic space is not entered and that muscle or fascia are the only anatomic structures crossed by the needle passer and mesh. No major vessels or nerves come in contact with the sling (FIGURES 7 and 8).

Our fluoroscopic observations of the transobturator sling in cadavers show that insertion of the needle passer through the obturator foramen with exit through the vaginal incision under the mid-urethra is precise and simple (FIGURE 9).

Our comparative studies in cadavers revealed that, despite the different shape and placement, lengths for the SPARC and Monarc transobturator slings in the same cadaver are almost equivalent—ranging from 12 to 14 cm, depending on the patient’s height and weight (FIGURE 10).

The transobturator sling involves fewer potential anatomical hazards than retropubic placement.

These considerations strongly suggest that the transobturator sling offers a simpler approach with fewer potential anatomic hazards than retropubic tension-free slings.

FIGURE 3 Vaginal incision

Inject a diluted vasoconstrictive solution into the anterior vaginal wall, and make a small vertical incision along the anterior vaginal mucosa 0.5 cm below the urethral meatus. Separate the vaginal epithelium from the underlying periurethral fascia using sharp and digital dissection, advancing bilaterally to the inferior pubic ramus. Insert a finger into the vaginal dissection and palpate the internal edge of the ischiopubic ramus and the upper-inner corner of the obturator foramen.

FIGURE 4 Needle entry: Transobturator sling procedure

The safe zone for needle insertion is the upper-inner corner of the obturator foramen (red line). The red dot indicates the recommended insertion site (upper inner corner).

The insertion area corresponds to the point where a horizontal line at the level of the clitoris crosses a vertical line at the level of the genitofemoral fold. Make a small skin incision at this point.

FIGURE 5 Needle passage: Transobturator sling procedure

Insert your left index finger into the vaginal incision on the patient’s left side. Holding the right-side Monarc needle, introduce the needle tip perpendicularly through the skin incision.

Place the thumb of your left hand onto the outside curve of the needle and gently push until its tip penetrates the obturator membrane and muscle. Use the needle’s tip to locate the pubic ramus, and rotate the needle so that the tip follows the posterior surface of this structure.

Continue this rotation, using your left index finger to guide the needle tip to exit the vaginal incision.

Repeat steps A and B on the contralateral side.

With the needle-passer tips extending out of the vaginal incision, attach the sling and its plastic sheath using the connectors. Make sure the mesh lies flat and is not twisted before attaching the connector to the second needle.

FIGURE 7 Route of transobturator sling minimizes anatomical hazards

The needle travels around the ischiopubic ramus. Transobturator needle passage begins with penetration of the skin and subcutaneous tissue. After traversing the superficial perineal fascia, the needle crosses the adductor muscles of the thigh near their pubic bone origin and below the insertion point of the adductor longus tendon (arrow). It then penetrates the obturator membrane, obturator internus muscle, and periurethral endopelvic fascia. After passing the level of the white line—either over or under the puborectalis section of the levator—the needle exits through the vaginal incision.

FIGURE 8 The obturator foramen

The tough obturator membrane covers the foramen. The obturator canal is 2 to 3 cm long and is located at the anterolateral upper margin of the membrane. The distance between the safe zone for needle insertion and the obturator canal is approximately 3.5 to 4 cm. At the safe entry zone (green area), the anterior branch of the obturator artery is reduced to a capillary diameter and no significant arteries, veins, or nerve pedicles are present.

FIGURE 10 Routes of transobturator and retropubic slings

Graphic depiction of both the transobturator sling and the retropubic tension-free sling in place.

Fluoroscopic image of both slings in a cadaver. The transobturator sling runs horizontally while the retropubic tension-free sling forms a tighter “U.”

Clinical experience yields positive results

Early European series and our initial experience suggest that the short-term efficacy of the Monarc transobturator sling is similar to that of the SPARC and TVT slings. Average operating time is 17 minutes. The technique involves a short learning curve (approximately 4 cases).

Cystoscopy is not routinely required; we perform it only in women with significant prolapse or suspected urethral injury, and have encountered no intraoperative or post-operative complications.

No major vessels or nerves come in contact with the transobturator tension-free sling.

No patients have complained of postoperative pain in the area of the adductor muscles of the thigh, and no sling erosions have occurred. We also have found this approach useful in obese patients and women with retropubic scarring, in whom retropubic needle passage can be a challenge.

In addition to its application in the treatment of female stress urinary incontinence, the transobturator foramen route was recently used to insert the anterior wings of a large mesh in the repair of severe cystocele.²⁷

Although long-term follow-up data are not available for the transobturator approach, short-term results are encouraging. Large comparative studies with other anti-incontinent procedures are needed.

Dr. Pelosi II reports that he is a consultant for American Medical Systems. Dr. Pelosi III reports no affiliations or financial arrangements with any companies whose products are mentioned in this article.

Potential complications associated with passing needle carriers through the retropubic space are eliminated, and cystoscopy is not routinely required with the use of a transobturator sling.

Although it is effective and easy to perform,^1-6 retropubic placement of suburethral tension-free vaginal tape (TVT) for the treatment of stress urinary incontinence has been associated with a number of bowel, vascular, nerve, and bladder injuries (TABLE).^7-13

Such complications appear to be related to the unique upward vaginal passage of the metallic sling trocars through the retropubic space. Newer slings eliminate the upward approach, but still require routine cystoscopy to confirm an intact bladder and urethra.

A new tension-free suburethral sling addresses these shortcomings using an innovative transobturator route.¹⁴ In the new procedure, the surgeon uses needle passers to run the sling from one obturator foramen to the other. The perineal approach reproduces the natural suspension of the urethral fascia while preserving an intact retropubic space (FIGURE 1).

TABLE

Advantages of the transobturator sling

FIGURE 1 Suburethral slings: Retropubic and transobturator pathways

Traditional suburethral tension-free slings require the needle passers and sling to be placed through the retropubic space.

The newer transobturator sling uses a perineal approach. The needle passer and sling are passed from one obturator foramen to the other, preserving an intact retropubic space.

What does ‘tension-free’ mean?

Tension-free slings are used to treat stress urinary incontinence caused by urethral hypermobility and intrinsic sphincter deficiency. In this approach, a synthetic transvaginal suburethral sling is placed through the retropubic space without using suspension sutures. The sling is held in place by the friction between the mesh and the tissue canals created by the metallic needle passers. Scar tissue later fixes the mesh, preventing migration.

Short-term efficacy of the Monarc transobturator sling is similar to that of the SPARC and tension-free vaginal slings.

Because the sling is not anchored to the pubic bone, ligaments, or rectus fascia, it is considered “free of tension.” The result is a midcomplex urethral support that limits urethral descent, improves the stabilization mechanism generated by pubourethral ligaments and levator ani muscles, and reinforces support of the backboard vaginal hammock.

A tension-free sling designed to reduce injury

Since its introduction in the mid 1990s, retropubic placement of suburethral tension-free tape has continued to gain in popularity.^15-22 The technique has several advantages: It is simple to perform under local, regional, or general anesthesia, and has proved to be a safe treatment for stress urinary incontinence, with minimal complications in experienced hands. Still, injuries have occurred^7-13 —likely due to the blind passing of metal trocars from the vagina upward through the retropubic space.^9,23

Downward placement introduced. In an effort to reduce these complications, tension-free sling systems that rely on suprapubic, downward needle-carrier placement through the retropubic space were developed, such as the SPARC Female Sling System (American Medical Systems, Minnetonka, Minn), introduced in 2001.²⁴ The manufacturer of the traditional TVT (Gynecare, a division of Ethicon, Somerville, NJ) also recently introduced suprapubic needle passers. However, because these slings still require passage through the retropubic space, their use may lead to vascular, bowel, and bladder injury. Routine cystoscopy is therefore required.

The transobturator sling. In the Netherlands in 1998, Nickel et al²⁵ reported a successful sling procedure using a polyester ribbon passed through the obturator foramen and around the urethra for treatment of refractory urethral sphincter incompetence in female dogs. In France in 2001, Delorme¹⁴ introduced the transobturator sling procedure in humans. Dargent et al²⁶ then performed the operation in 71 patients using a technique inspired by Delorme, and found the shortterm results similar to those of the TVT.

The Monarc transobturator sling (American Medical Systems), introduced in Europe in January 2003, has been used successfully in more than 1,000 procedures ( FIGURE 2). This new system offers significant technical improvements over the original transobturator sling devices.

The Monarc transobturator sling, introduced in Europe in January 2003, has been used successfully in more than 1,000 procedures.

Specifically, the Monarc system simplifies rotation of the needle passer during insertion and extraction around the inferior aspect of the ischiopubic ramus. The 3-mm–diameter passers are specifically designed for right-side or left-side use. They are attached to fixed handles to create a natural wrist rotation. The sling connectors, meanwhile, facilitate rapid, effortless, and secure mesh placement and fixation.

FIGURE 2 Monarc transobturator sling system

The Monarc system consists of 2 stainless steel helical-shaped needle passers and a 1-cm by 35-cm polypropylene sling mesh with a protected sheath, attached connectors, and a reabsorbable tensioning suture.

Easy to learn and perform

Anesthesia may be local, regional, or general, and prophylactic antibiotics are routinely given. FIGURES 3 through 6 offer a detailed description of how to surgically place the Monarc transobturator sling for treatment of stress urinary incontinence. What follows is a brief overview:

After making a small vertical incision along the anterior vaginal mucosa, use a finger to locate the upper-inner corner of the obturator foramen—the safe zone for needle insertion. You will incise the skin at this point and introduce the needle tip perpendicularly. Rotate the needle, with the tip following the posterior surface of the pubic ramus, until the tip exits the vaginal incision. Repeat this process on the other side.

Attach the sling and its plastic sheath, then draw both out through the skin incisions by pulling back on the needle passers. Cut the mesh, adjust the tension, and close the incisions.

A Foley catheter and vaginal packing with metronidazole gel may be used at the surgeon’s discretion.

Route minimizes anatomical hazards. The pathway described ensures that there tropubic space is not entered and that muscle or fascia are the only anatomic structures crossed by the needle passer and mesh. No major vessels or nerves come in contact with the sling (FIGURES 7 and 8).

Our fluoroscopic observations of the transobturator sling in cadavers show that insertion of the needle passer through the obturator foramen with exit through the vaginal incision under the mid-urethra is precise and simple (FIGURE 9).

Our comparative studies in cadavers revealed that, despite the different shape and placement, lengths for the SPARC and Monarc transobturator slings in the same cadaver are almost equivalent—ranging from 12 to 14 cm, depending on the patient’s height and weight (FIGURE 10).

The transobturator sling involves fewer potential anatomical hazards than retropubic placement.

These considerations strongly suggest that the transobturator sling offers a simpler approach with fewer potential anatomic hazards than retropubic tension-free slings.

FIGURE 3 Vaginal incision

Inject a diluted vasoconstrictive solution into the anterior vaginal wall, and make a small vertical incision along the anterior vaginal mucosa 0.5 cm below the urethral meatus. Separate the vaginal epithelium from the underlying periurethral fascia using sharp and digital dissection, advancing bilaterally to the inferior pubic ramus. Insert a finger into the vaginal dissection and palpate the internal edge of the ischiopubic ramus and the upper-inner corner of the obturator foramen.

FIGURE 4 Needle entry: Transobturator sling procedure

The safe zone for needle insertion is the upper-inner corner of the obturator foramen (red line). The red dot indicates the recommended insertion site (upper inner corner).

The insertion area corresponds to the point where a horizontal line at the level of the clitoris crosses a vertical line at the level of the genitofemoral fold. Make a small skin incision at this point.

FIGURE 5 Needle passage: Transobturator sling procedure

Insert your left index finger into the vaginal incision on the patient’s left side. Holding the right-side Monarc needle, introduce the needle tip perpendicularly through the skin incision.

Place the thumb of your left hand onto the outside curve of the needle and gently push until its tip penetrates the obturator membrane and muscle. Use the needle’s tip to locate the pubic ramus, and rotate the needle so that the tip follows the posterior surface of this structure.

Continue this rotation, using your left index finger to guide the needle tip to exit the vaginal incision.

Repeat steps A and B on the contralateral side.

With the needle-passer tips extending out of the vaginal incision, attach the sling and its plastic sheath using the connectors. Make sure the mesh lies flat and is not twisted before attaching the connector to the second needle.

FIGURE 7 Route of transobturator sling minimizes anatomical hazards

The needle travels around the ischiopubic ramus. Transobturator needle passage begins with penetration of the skin and subcutaneous tissue. After traversing the superficial perineal fascia, the needle crosses the adductor muscles of the thigh near their pubic bone origin and below the insertion point of the adductor longus tendon (arrow). It then penetrates the obturator membrane, obturator internus muscle, and periurethral endopelvic fascia. After passing the level of the white line—either over or under the puborectalis section of the levator—the needle exits through the vaginal incision.

FIGURE 8 The obturator foramen

The tough obturator membrane covers the foramen. The obturator canal is 2 to 3 cm long and is located at the anterolateral upper margin of the membrane. The distance between the safe zone for needle insertion and the obturator canal is approximately 3.5 to 4 cm. At the safe entry zone (green area), the anterior branch of the obturator artery is reduced to a capillary diameter and no significant arteries, veins, or nerve pedicles are present.

FIGURE 10 Routes of transobturator and retropubic slings

Graphic depiction of both the transobturator sling and the retropubic tension-free sling in place.

Fluoroscopic image of both slings in a cadaver. The transobturator sling runs horizontally while the retropubic tension-free sling forms a tighter “U.”

Clinical experience yields positive results

Early European series and our initial experience suggest that the short-term efficacy of the Monarc transobturator sling is similar to that of the SPARC and TVT slings. Average operating time is 17 minutes. The technique involves a short learning curve (approximately 4 cases).

Cystoscopy is not routinely required; we perform it only in women with significant prolapse or suspected urethral injury, and have encountered no intraoperative or post-operative complications.

No major vessels or nerves come in contact with the transobturator tension-free sling.

No patients have complained of postoperative pain in the area of the adductor muscles of the thigh, and no sling erosions have occurred. We also have found this approach useful in obese patients and women with retropubic scarring, in whom retropubic needle passage can be a challenge.

In addition to its application in the treatment of female stress urinary incontinence, the transobturator foramen route was recently used to insert the anterior wings of a large mesh in the repair of severe cystocele.²⁷

Although long-term follow-up data are not available for the transobturator approach, short-term results are encouraging. Large comparative studies with other anti-incontinent procedures are needed.

Dr. Pelosi II reports that he is a consultant for American Medical Systems. Dr. Pelosi III reports no affiliations or financial arrangements with any companies whose products are mentioned in this article.

Potential complications associated with passing needle carriers through the retropubic space are eliminated, and cystoscopy is not routinely required with the use of a transobturator sling.

Although it is effective and easy to perform,^1-6 retropubic placement of suburethral tension-free vaginal tape (TVT) for the treatment of stress urinary incontinence has been associated with a number of bowel, vascular, nerve, and bladder injuries (TABLE).^7-13

Such complications appear to be related to the unique upward vaginal passage of the metallic sling trocars through the retropubic space. Newer slings eliminate the upward approach, but still require routine cystoscopy to confirm an intact bladder and urethra.

A new tension-free suburethral sling addresses these shortcomings using an innovative transobturator route.¹⁴ In the new procedure, the surgeon uses needle passers to run the sling from one obturator foramen to the other. The perineal approach reproduces the natural suspension of the urethral fascia while preserving an intact retropubic space (FIGURE 1).

TABLE

Advantages of the transobturator sling

FIGURE 1 Suburethral slings: Retropubic and transobturator pathways

Traditional suburethral tension-free slings require the needle passers and sling to be placed through the retropubic space.

The newer transobturator sling uses a perineal approach. The needle passer and sling are passed from one obturator foramen to the other, preserving an intact retropubic space.

What does ‘tension-free’ mean?

Tension-free slings are used to treat stress urinary incontinence caused by urethral hypermobility and intrinsic sphincter deficiency. In this approach, a synthetic transvaginal suburethral sling is placed through the retropubic space without using suspension sutures. The sling is held in place by the friction between the mesh and the tissue canals created by the metallic needle passers. Scar tissue later fixes the mesh, preventing migration.

Short-term efficacy of the Monarc transobturator sling is similar to that of the SPARC and tension-free vaginal slings.

Because the sling is not anchored to the pubic bone, ligaments, or rectus fascia, it is considered “free of tension.” The result is a midcomplex urethral support that limits urethral descent, improves the stabilization mechanism generated by pubourethral ligaments and levator ani muscles, and reinforces support of the backboard vaginal hammock.

A tension-free sling designed to reduce injury

Since its introduction in the mid 1990s, retropubic placement of suburethral tension-free tape has continued to gain in popularity.^15-22 The technique has several advantages: It is simple to perform under local, regional, or general anesthesia, and has proved to be a safe treatment for stress urinary incontinence, with minimal complications in experienced hands. Still, injuries have occurred^7-13 —likely due to the blind passing of metal trocars from the vagina upward through the retropubic space.^9,23

Downward placement introduced. In an effort to reduce these complications, tension-free sling systems that rely on suprapubic, downward needle-carrier placement through the retropubic space were developed, such as the SPARC Female Sling System (American Medical Systems, Minnetonka, Minn), introduced in 2001.²⁴ The manufacturer of the traditional TVT (Gynecare, a division of Ethicon, Somerville, NJ) also recently introduced suprapubic needle passers. However, because these slings still require passage through the retropubic space, their use may lead to vascular, bowel, and bladder injury. Routine cystoscopy is therefore required.

The transobturator sling. In the Netherlands in 1998, Nickel et al²⁵ reported a successful sling procedure using a polyester ribbon passed through the obturator foramen and around the urethra for treatment of refractory urethral sphincter incompetence in female dogs. In France in 2001, Delorme¹⁴ introduced the transobturator sling procedure in humans. Dargent et al²⁶ then performed the operation in 71 patients using a technique inspired by Delorme, and found the shortterm results similar to those of the TVT.

The Monarc transobturator sling (American Medical Systems), introduced in Europe in January 2003, has been used successfully in more than 1,000 procedures ( FIGURE 2). This new system offers significant technical improvements over the original transobturator sling devices.

The Monarc transobturator sling, introduced in Europe in January 2003, has been used successfully in more than 1,000 procedures.

Specifically, the Monarc system simplifies rotation of the needle passer during insertion and extraction around the inferior aspect of the ischiopubic ramus. The 3-mm–diameter passers are specifically designed for right-side or left-side use. They are attached to fixed handles to create a natural wrist rotation. The sling connectors, meanwhile, facilitate rapid, effortless, and secure mesh placement and fixation.

FIGURE 2 Monarc transobturator sling system

The Monarc system consists of 2 stainless steel helical-shaped needle passers and a 1-cm by 35-cm polypropylene sling mesh with a protected sheath, attached connectors, and a reabsorbable tensioning suture.

Easy to learn and perform

Anesthesia may be local, regional, or general, and prophylactic antibiotics are routinely given. FIGURES 3 through 6 offer a detailed description of how to surgically place the Monarc transobturator sling for treatment of stress urinary incontinence. What follows is a brief overview:

After making a small vertical incision along the anterior vaginal mucosa, use a finger to locate the upper-inner corner of the obturator foramen—the safe zone for needle insertion. You will incise the skin at this point and introduce the needle tip perpendicularly. Rotate the needle, with the tip following the posterior surface of the pubic ramus, until the tip exits the vaginal incision. Repeat this process on the other side.

Attach the sling and its plastic sheath, then draw both out through the skin incisions by pulling back on the needle passers. Cut the mesh, adjust the tension, and close the incisions.

A Foley catheter and vaginal packing with metronidazole gel may be used at the surgeon’s discretion.

Route minimizes anatomical hazards. The pathway described ensures that there tropubic space is not entered and that muscle or fascia are the only anatomic structures crossed by the needle passer and mesh. No major vessels or nerves come in contact with the sling (FIGURES 7 and 8).

Our fluoroscopic observations of the transobturator sling in cadavers show that insertion of the needle passer through the obturator foramen with exit through the vaginal incision under the mid-urethra is precise and simple (FIGURE 9).

Our comparative studies in cadavers revealed that, despite the different shape and placement, lengths for the SPARC and Monarc transobturator slings in the same cadaver are almost equivalent—ranging from 12 to 14 cm, depending on the patient’s height and weight (FIGURE 10).

The transobturator sling involves fewer potential anatomical hazards than retropubic placement.

These considerations strongly suggest that the transobturator sling offers a simpler approach with fewer potential anatomic hazards than retropubic tension-free slings.

FIGURE 3 Vaginal incision

Inject a diluted vasoconstrictive solution into the anterior vaginal wall, and make a small vertical incision along the anterior vaginal mucosa 0.5 cm below the urethral meatus. Separate the vaginal epithelium from the underlying periurethral fascia using sharp and digital dissection, advancing bilaterally to the inferior pubic ramus. Insert a finger into the vaginal dissection and palpate the internal edge of the ischiopubic ramus and the upper-inner corner of the obturator foramen.

FIGURE 4 Needle entry: Transobturator sling procedure

The safe zone for needle insertion is the upper-inner corner of the obturator foramen (red line). The red dot indicates the recommended insertion site (upper inner corner).

The insertion area corresponds to the point where a horizontal line at the level of the clitoris crosses a vertical line at the level of the genitofemoral fold. Make a small skin incision at this point.

FIGURE 5 Needle passage: Transobturator sling procedure

Insert your left index finger into the vaginal incision on the patient’s left side. Holding the right-side Monarc needle, introduce the needle tip perpendicularly through the skin incision.

Place the thumb of your left hand onto the outside curve of the needle and gently push until its tip penetrates the obturator membrane and muscle. Use the needle’s tip to locate the pubic ramus, and rotate the needle so that the tip follows the posterior surface of this structure.

Continue this rotation, using your left index finger to guide the needle tip to exit the vaginal incision.

Repeat steps A and B on the contralateral side.

With the needle-passer tips extending out of the vaginal incision, attach the sling and its plastic sheath using the connectors. Make sure the mesh lies flat and is not twisted before attaching the connector to the second needle.

FIGURE 7 Route of transobturator sling minimizes anatomical hazards

The needle travels around the ischiopubic ramus. Transobturator needle passage begins with penetration of the skin and subcutaneous tissue. After traversing the superficial perineal fascia, the needle crosses the adductor muscles of the thigh near their pubic bone origin and below the insertion point of the adductor longus tendon (arrow). It then penetrates the obturator membrane, obturator internus muscle, and periurethral endopelvic fascia. After passing the level of the white line—either over or under the puborectalis section of the levator—the needle exits through the vaginal incision.

FIGURE 8 The obturator foramen

The tough obturator membrane covers the foramen. The obturator canal is 2 to 3 cm long and is located at the anterolateral upper margin of the membrane. The distance between the safe zone for needle insertion and the obturator canal is approximately 3.5 to 4 cm. At the safe entry zone (green area), the anterior branch of the obturator artery is reduced to a capillary diameter and no significant arteries, veins, or nerve pedicles are present.

FIGURE 10 Routes of transobturator and retropubic slings

Graphic depiction of both the transobturator sling and the retropubic tension-free sling in place.

Fluoroscopic image of both slings in a cadaver. The transobturator sling runs horizontally while the retropubic tension-free sling forms a tighter “U.”

Clinical experience yields positive results

Early European series and our initial experience suggest that the short-term efficacy of the Monarc transobturator sling is similar to that of the SPARC and TVT slings. Average operating time is 17 minutes. The technique involves a short learning curve (approximately 4 cases).

Cystoscopy is not routinely required; we perform it only in women with significant prolapse or suspected urethral injury, and have encountered no intraoperative or post-operative complications.

No major vessels or nerves come in contact with the transobturator tension-free sling.

No patients have complained of postoperative pain in the area of the adductor muscles of the thigh, and no sling erosions have occurred. We also have found this approach useful in obese patients and women with retropubic scarring, in whom retropubic needle passage can be a challenge.

In addition to its application in the treatment of female stress urinary incontinence, the transobturator foramen route was recently used to insert the anterior wings of a large mesh in the repair of severe cystocele.²⁷

Although long-term follow-up data are not available for the transobturator approach, short-term results are encouraging. Large comparative studies with other anti-incontinent procedures are needed.

Dr. Pelosi II reports that he is a consultant for American Medical Systems. Dr. Pelosi III reports no affiliations or financial arrangements with any companies whose products are mentioned in this article.

Abdominal myomectomy is the preferred treatment in women with large or numerous intramural myomas, especially in the setting of infertility, recurrent pregnancy loss, and preservation of future fertility.^1,2 However, postoperative adhesions are distressingly common following this procedure, resulting in significant potential morbidity. Fortunately, a number of products can reduce their occurrence. Proper surgical techniques and a thorough knowledge of these products are invaluable in helping reduce the incidence of adhesions.

The association between adhesions and diminished fertility is well-established,^3,4 particularly when peritubal involvement is present (FIGURES 1-3). Abdominopelvic adhesions also contribute to significant chronic pelvic pain, bowel obstruction, and technical difficulty in subsequent surgical or assisted-reproduction procedures.⁵ Unfortunately, most attempts at adhesiolysis meet with less than complete success, since adhesions recur in 55% to 100% of patients (FIGURE 4).⁶ Thus, preventing adhesions in the first place would seem to be key to successful outcomes in abdominal myomectomy.

This article reviews the evidence on various approaches and products. While the number of studies examining each adjuvant in the setting of abdominal myomectomy is limited, the overall evidence supports the safety and efficacy of both liquid and barrier adjuvants.

Adhesions present a significant clinical dilemma after abdominal myomectomy, occurring in 50% to 90% of patients.^5,7 In 1 prospective series of women undergoing second-look laparoscopy (SLL) after myomectomy, adnexal adhesions were noted in 94% of patients with posterior uterine incisions and in 56% of patients with only anterior or fundal incisions; adhesions between the uterus and omentum or bowel occurred in 88% of all patients.⁵

In another study of early SLL following abdominal myomectomy, 83% of patients had adhesions between the surgical site and the bowel or omentum, and 65% had adhesions involving the adnexae.² Removal of large, bulky fibroids (with uterine mass exceeding 13 weeks’ gestational size) resulted in higher adhesion scores than did small myomas. Again, the incidence and severity of adhesions also correlated with location of the uterine incision: Adnexal adhesions were more common after posterior uterine incisions (76%) than after anterior or fundal entries (45%).²

FIGURE 1 Peritubal adhesion

Adhesion at distal end of the fallopian tube. Peritubal involvement often leads to diminished fertility.

FIGURE 2 Adherent structures

Postoperative adhesion between fallopian tube and the uterus.

FIGURE 3 Cyst dissection

Adhesions can follow common surgeries such as paratubal cyst dissection.

FIGURE 4 Recurrent adhesions

Adhesions may recur following adhesiolysis.

Causes of pelvic adhesions

Adhesion prevention requires an understanding of risk factors and maneuvers that increase the likelihood of injury (see “Pathophysiology of adhesion formation”). A number of causes have been proposed, most of them centering on tissue and peritoneal trauma (TABLE 1).

Injury can arise from excessive or rough manipulation of tissue and peritoneal surfaces or from common effects such as cutting, abrasion, and denudation (FIGURE 5). Tissue desiccation or manual blotting may lead to peritoneal desquamation and fibrin deposition.

Exposure of surfaces to intraperitoneal blood in the setting of tissue hypoxia—virtually unavoidable during abdominal myomectomy—disrupts normal fibrinolytic activity, resulting in stimulation of angiogenesis.⁸

Introduction of reactive foreign bodies such as talc powder, residual suture material, and even lint from laparotomy pads can favor adhesion formation. These serve as substrates or niduses of fibrin deposition.

FIGURE 5 Conducive conditions

Raw surface area can become a potent substrate for adhesions.TABLE 1

Proposed causes of adhesion formation

Techniques that may help prevent adhesions

Based on findings from studies of second-look procedures, most physicians advocate avoiding posterior uterine incisions, as well as minimizing the number and extent of incisions, to help reduce the likelihood of adhesion formation. Further, many Ob/Gyns favor removing myomas through as few uterine incisions as possible.⁹ We select anterior hysterotomy sites that enable removal of multiple fibroids, avoiding posterior incisions and the uterotubal junction whenever possible.

Interestingly, reapproximation of peritoneal defects after reproductive surgery (and, probably, myomectomy) does not appear to help prevent adhesions. Tulandi and colleagues¹⁰ examined the clinical and SLL outcomes of peritoneal closure in patients undergoing Pfannenstiel incisions with or without peritoneal closure at the end of the procedure. There was no difference in postoperative complications or wound healing in the 2 groups. At the time of SLL, there was no significant difference in the incidence of adhesion formation at the anterior abdominal wall.

Principles of microsurgery have been adopted by reproductive surgeons to minimize the likelihood of adhesions after myomectomy and gynecologic surgery in general. The basic techniques reflect respect for tissue integrity:

• Gentle handling of tissue, with minimal manipulation of all peritoneal surfaces.
• Meticulous hemostasis. Examine all myomectomy sites to ensure adequate hemostasis prior to closure.
• Continuous irrigation to prevent tissue desiccation. We favor continuous saline irrigation throughout the procedure. We also use only moistened laparotomy sponges and pads, and avoid applying dry gauze to any tissue surface.
• Avoidance of foreign-body introduction. We use only talc-free gloves and remove all residual suture fragments and tissue debris before closure. We also perform copious saline suction-irrigation at the end of the procedure to remove as much residue as possible.
• Use of fine, nonreactive suture. We favor fine, resorbable sutures that incite as little tissue reactivity as possible. For closure of large myomectomy defects, we use braided multifilaments such as Vicryl (polyglactine 910) (Ethicon, Somerville, NJ) or Dexon (polyglycolic acid) (Davis and Geck, Danbury, Conn) for strength and ease of handling. These sutures are absorbed through simple hydrolysis and stimulate less tissue reactivity than do chromic or catgut sutures.

The idea is appealing, but a randomized, blinded comparison of “good” and “bad” microsurgical technique is unlikely, since no one would wish to perform “bad” technique.

With barrier adjuvants, optimal benefit is obtained when the physician can predict potential sites of adhesions.

Wide range of prevention tools has been studied

Many types of agents have been studied in an attempt to reduce postsurgical adhesions after gynecologic surgery. Although most offer little or no benefit (TABLE 2), a few have potential in myomectomy procedures.

Barriers that form mechanical separation (TABLE 3) theoretically physically separate damaged tissues during early peritoneal wound healing, when adhesions form.¹¹ The original adhesion barriers consisted of omental and peritoneal grafts that were placed over surgical sites. However, studies demonstrated that devitalized tissue positioned on damaged peritoneum serves as a potent substrate—not inhibitor—for adhesions.¹² More recent trials have examined the adhesion-prevention benefit of other types of absorbable and nonabsorbable barriers.

TABLE 2

Pharmacologic agents studied for adhesion prevention in reproductive surgery

TABLE 3

Fluid and barrier adjuvants studied for adhesion reduction after myomectomy

Absorbable barriers

These are largely derivatives of organic materials. Their application to myomectomy may be limited by the requirement for absolute hemostasis at the site of application.

Interceed (Gynecare, a division of Ethicon), which is derived from oxidized regenerated cellulose, is one of the first and most extensively evaluated barriers. A mesh synthetic designed to be placed over injured tissue, it is a derivative of the hemostatic agent Surgicell (Johnson & Johnson, New Brunswick, NJ), with modifications in weave and pore size.

Interceed offers ease of application: It can be cut to the size or shape necessary and requires no suturing. It forms a gelatinous protective layer within 8 hours of placement, and is degraded into monosaccharides and absorbed within 2 weeks.¹³

The use of Interceed has been shown to reduce adhesions following adhesiolysis and ovarian surgery. In a large, multicenter, prospective, randomized trial, it significantly decreased the incidence of adhesion reformation after adnexal adhesiolysis in infertility patients with bilateral tubal disease.¹⁴

In a retrospective series of 38 infertility patients, including 19 patients after myomectomy (13 with the barrier, 6 without), reproductive outcomes were significantly better in the Interceed group, and adhesion development was reduced.¹⁵ Pregnancy rates in the 2 years following surgery were 78% in the Interceed group, compared with 47% in controls. In addition, among 23 patients who had second-look procedures, postoperative adhesions were noted in 38% of the Interceed group, compared with 86% in controls.¹⁵

Seprafilm (hyaluronic acid-film) (Genzyme Corp, Cambridge, Mass) is a bioresorbable membrane derived from sodium hyaluronate and carboxymethylcellulose. It is absorbed from the peritoneal cavity within 1 week and is completely excreted within 1 month.

Its potential for adhesion prevention after abdominal myomectomy was examined by SLL in a multicenter, prospective, randomized, blinded study¹¹ in which 127 women undergoing abdominal myomectomy at 19 institutions were randomized to either Seprafilm or no barrier. In the Seprafilm group, the barrier was wrapped circumferentially around the uterus, covering all uterine defects, at the time of abdominal closure. Clinical outcomes—including vital signs, adverse events (pain, fever, nausea), and abdominal wound complications—were similar in the control and Seprafilm groups.

In this study, the incidence (mean number of sites), severity, and extent (mean area) of uterine adhesions were significantly lower in the Seprafilm-treated patients. The proportion of patients undergoing anterior hysterotomies who were found to have no anterior uterine adhesions was 39% in the Seprafilm group, compared with 6% in the control group. The percentage of patients with at least 1 adnexa totally free of adhesions to the posterior uterus also was higher in the Seprafilm group—48% versus 31%.¹¹

Nonabsorbable barriers

GoreTex Surgical Membrane (W.L. Gore and Associates, Newark, Del) is an inert expanded polytetrafluoroethylene (PTFE) derivative that must be sutured in place. It is of potential utility in myomectomy because its application does not require absolute hemostasis. However, its usefulness and application are limited by the need for later removal.

In a multicenter, randomized, controlled trial exploring its adhesion-preventive properties after myomectomy, the GoreTex membrane significantly outperformed the barrierfree group.¹⁶

In a separate multicenter, randomized clinical trial, the GoreTex membrane was more effective than Interceed in preventing adhesions after pelvic/tubal reconstructive surgery.¹⁷

Yet another multicenter, randomized trial—this one involving 27 women undergoing abdominal myomectomy—used SLL to determine the extent of adhesions and to remove the barrier. The percentage of adhesion-free surgical sites was significantly higher in the GoreTex group: 56% compared with 7% in no-barrier controls.¹⁶

The adhesion scores, determined by the extent (area of involvement), nature (filmy versus opaque), and tenacity (ease of lysis or dissection) of the adhesions, were significantly lower in the GoreTex group.¹⁶

Despite the few prospective, randomized trials, the evidence supports the efficacy of various fluid and barrier adjuvants.

Histologic examination of the removed barriers demonstrated no tissue attachment to the PTFE. Despite these positive findings, however, both fistula formation and graft infection have been reported after placement of a GoreTex barrier.¹⁸

The Shelhigh Pericardial No-React Patch (Herzog Surgical, Sacramento, Calif) is a new nonabsorbable adhesion barrier that was first described in gynecologic use by Pelosi and Pelosi in a case series of 20 patients.¹⁹ Consisting of a 12-cm-diameter patch of glutaraldehyde-treated bovine/porcine pericardium, this product has an excellent safety record as a permanent pericardial substitute in the cardiovascular literature and has been shown to resist calcification and adhesions.

In the Pelosi series, the patch was placed over the uterine fundus and secured by 4 monofilament sutures at the dome of the uterus and the parietal peritoneum.¹⁹ All patients underwent SLL at 6 weeks, and 3 patients also underwent third-look laparoscopy. None of the 20 women had adhesions between the abdominal wall and the bladder, bowel, uterus, or adnexae at SLL. However, minimal adhesions of the ovaries and tubes were found in 7 patients who had undergone posterior hysterotomy. Clinical trials are likely to follow this small pilot study.

Absorbable fluid adjuvants

With barrier adjuvants, optimal benefit is obtained when the physician can predict potential sites of adhesions. This is not a strict requirement with fluid barriers, which is their chief advantage. Among the agents described below, Sepracoat (Genzyme Corp) is available in the United States, while Intergel (Lifecore Biomedical, Chaska, Minn) was withdrawn from the market in March.

Intergel, a 0.5% ferric hyaluronade formulation, is a sterile nonpyrogenic gel of highly purified sodium hyaluronate, which is ionically cross-linked with ferric ion and adjusted to isotonicity with sodium chloride.¹¹ (Hyaluronic acid is a major component of body tissues and fluids such as peritoneal fluid, where it performs physically supportive and mechanically protective roles.)

Johns and colleagues²⁰ studied Intergel in a randomized, multicenter, third-party– blinded, placebo-controlled study. Of the 265 patients who completed the study, 131 were given 300 mL of Intergel and 134 were given lactated Ringer’s solution (the placebo) at the time of their surgery, through the laparoscopic port. When SLL was performed 6 to 12 weeks after surgery, the mean number and severity of adhesions—overall and at the surgical site—were significantly lower in the Intergel group. Adhesions reformed in 91% of those in the control group, compared with 63% in the Intergel group.

In myomectomy patients, the modified American Fertility Society Score, which uses 24 potential adhesion sites, was reduced by 42% in the Intergel group—a statistically significant improvement.²⁰

One major advantage of Intergel is that it reduces adhesion formation at sites distant from the area of application, secondary to its wide intra-abdominal circulation. However, as mentioned above, sales were voluntarily suspended due to post-market reports of tissue adherence, sterile foreign-body reaction, and late-onset pain that sometimes required surgical intervention. In some patients, persistent residual material was noted at the time of subsequent surgery.

Sepracoat (hyaluronic acid-coat) is a dilute solution of 0.4% hyaluronic acid in phosphate-buffered saline. It is bioresorbable, persists at the application site less than 24 hours, and is completely cleared in less than 5 days.

In a prospective, randomized, blinded, placebo-controlled, multicenter study in 1998, Diamond and colleagues compared Sepracoat with a pure phosphate-buffered saline solution in 227 women undergoing gynecologic procedures via laparotomy.²¹ The aim of the study was to assess the efficacy and safety of the fluid at sites without direct surgical trauma or adhesiolysis. Both solutions were warmed to room temperature and injected into the abdominal cavity before the procedure began (250 mL after skin incision). The solution was reapplied after irrigation or every 30 minutes (100 mL), and at the end of the procedure (250 mL) before closure. The maximum volume used was 1,000 mL. After application, the fluid was left 1 minute before suctioning. Patients underwent SLL 40 days later, and adhesions were identified at the initial procedure and at SLL.

In the Sepracoat group, there was a reduction in de novo adhesions at nonsurgical sites by a factor of 2.8. The proportion of sites with de novo adhesions also decreased, and 80% of Sepracoat patients had at least 1 ovary that was adhesion-free compared with 58% of placebo-treated patients. These findings occurred in areas of indirect trauma, demonstrating that Sepracoat limited trauma at tissue injury.²¹

Conclusion

Adhesion prevention is of utmost importance after abdominal myomectomy, especially in patients who desire future fertility. Despite the limited number of prospective, randomized studies, the literature does support the efficacy of various fluid and barrier adjuvants.

Our practice is to use an adjuvant in all abdominal myomectomies. We have long relied on Interceed, which enjoys both ease of application and an excellent safety record. However, as reviewed above, other potentially useful products are available or in development. As ever, the reproductive surgeon should adhere to principles of microsurgery, strive for meticulous hemostasis, and demonstrate respect for tissue integrity.

Dr. DeCherney reports small holdings with Lifecore Biomedical. Drs. Chang and Marin report no affiliations or financial arrangements with any of the manufacturers of products mentioned in this article.

Abdominal myomectomy is the preferred treatment in women with large or numerous intramural myomas, especially in the setting of infertility, recurrent pregnancy loss, and preservation of future fertility.^1,2 However, postoperative adhesions are distressingly common following this procedure, resulting in significant potential morbidity. Fortunately, a number of products can reduce their occurrence. Proper surgical techniques and a thorough knowledge of these products are invaluable in helping reduce the incidence of adhesions.

The association between adhesions and diminished fertility is well-established,^3,4 particularly when peritubal involvement is present (FIGURES 1-3). Abdominopelvic adhesions also contribute to significant chronic pelvic pain, bowel obstruction, and technical difficulty in subsequent surgical or assisted-reproduction procedures.⁵ Unfortunately, most attempts at adhesiolysis meet with less than complete success, since adhesions recur in 55% to 100% of patients (FIGURE 4).⁶ Thus, preventing adhesions in the first place would seem to be key to successful outcomes in abdominal myomectomy.

This article reviews the evidence on various approaches and products. While the number of studies examining each adjuvant in the setting of abdominal myomectomy is limited, the overall evidence supports the safety and efficacy of both liquid and barrier adjuvants.

Adhesions present a significant clinical dilemma after abdominal myomectomy, occurring in 50% to 90% of patients.^5,7 In 1 prospective series of women undergoing second-look laparoscopy (SLL) after myomectomy, adnexal adhesions were noted in 94% of patients with posterior uterine incisions and in 56% of patients with only anterior or fundal incisions; adhesions between the uterus and omentum or bowel occurred in 88% of all patients.⁵

In another study of early SLL following abdominal myomectomy, 83% of patients had adhesions between the surgical site and the bowel or omentum, and 65% had adhesions involving the adnexae.² Removal of large, bulky fibroids (with uterine mass exceeding 13 weeks’ gestational size) resulted in higher adhesion scores than did small myomas. Again, the incidence and severity of adhesions also correlated with location of the uterine incision: Adnexal adhesions were more common after posterior uterine incisions (76%) than after anterior or fundal entries (45%).²

FIGURE 1 Peritubal adhesion

Adhesion at distal end of the fallopian tube. Peritubal involvement often leads to diminished fertility.

FIGURE 2 Adherent structures

Postoperative adhesion between fallopian tube and the uterus.

FIGURE 3 Cyst dissection

Adhesions can follow common surgeries such as paratubal cyst dissection.

FIGURE 4 Recurrent adhesions

Adhesions may recur following adhesiolysis.

Causes of pelvic adhesions

Adhesion prevention requires an understanding of risk factors and maneuvers that increase the likelihood of injury (see “Pathophysiology of adhesion formation”). A number of causes have been proposed, most of them centering on tissue and peritoneal trauma (TABLE 1).

Injury can arise from excessive or rough manipulation of tissue and peritoneal surfaces or from common effects such as cutting, abrasion, and denudation (FIGURE 5). Tissue desiccation or manual blotting may lead to peritoneal desquamation and fibrin deposition.

Exposure of surfaces to intraperitoneal blood in the setting of tissue hypoxia—virtually unavoidable during abdominal myomectomy—disrupts normal fibrinolytic activity, resulting in stimulation of angiogenesis.⁸

Introduction of reactive foreign bodies such as talc powder, residual suture material, and even lint from laparotomy pads can favor adhesion formation. These serve as substrates or niduses of fibrin deposition.

FIGURE 5 Conducive conditions

Raw surface area can become a potent substrate for adhesions.TABLE 1

Proposed causes of adhesion formation

Techniques that may help prevent adhesions

Based on findings from studies of second-look procedures, most physicians advocate avoiding posterior uterine incisions, as well as minimizing the number and extent of incisions, to help reduce the likelihood of adhesion formation. Further, many Ob/Gyns favor removing myomas through as few uterine incisions as possible.⁹ We select anterior hysterotomy sites that enable removal of multiple fibroids, avoiding posterior incisions and the uterotubal junction whenever possible.

Interestingly, reapproximation of peritoneal defects after reproductive surgery (and, probably, myomectomy) does not appear to help prevent adhesions. Tulandi and colleagues¹⁰ examined the clinical and SLL outcomes of peritoneal closure in patients undergoing Pfannenstiel incisions with or without peritoneal closure at the end of the procedure. There was no difference in postoperative complications or wound healing in the 2 groups. At the time of SLL, there was no significant difference in the incidence of adhesion formation at the anterior abdominal wall.

Principles of microsurgery have been adopted by reproductive surgeons to minimize the likelihood of adhesions after myomectomy and gynecologic surgery in general. The basic techniques reflect respect for tissue integrity:

• Gentle handling of tissue, with minimal manipulation of all peritoneal surfaces.
• Meticulous hemostasis. Examine all myomectomy sites to ensure adequate hemostasis prior to closure.
• Continuous irrigation to prevent tissue desiccation. We favor continuous saline irrigation throughout the procedure. We also use only moistened laparotomy sponges and pads, and avoid applying dry gauze to any tissue surface.
• Avoidance of foreign-body introduction. We use only talc-free gloves and remove all residual suture fragments and tissue debris before closure. We also perform copious saline suction-irrigation at the end of the procedure to remove as much residue as possible.
• Use of fine, nonreactive suture. We favor fine, resorbable sutures that incite as little tissue reactivity as possible. For closure of large myomectomy defects, we use braided multifilaments such as Vicryl (polyglactine 910) (Ethicon, Somerville, NJ) or Dexon (polyglycolic acid) (Davis and Geck, Danbury, Conn) for strength and ease of handling. These sutures are absorbed through simple hydrolysis and stimulate less tissue reactivity than do chromic or catgut sutures.

The idea is appealing, but a randomized, blinded comparison of “good” and “bad” microsurgical technique is unlikely, since no one would wish to perform “bad” technique.

With barrier adjuvants, optimal benefit is obtained when the physician can predict potential sites of adhesions.

Wide range of prevention tools has been studied

Many types of agents have been studied in an attempt to reduce postsurgical adhesions after gynecologic surgery. Although most offer little or no benefit (TABLE 2), a few have potential in myomectomy procedures.

Barriers that form mechanical separation (TABLE 3) theoretically physically separate damaged tissues during early peritoneal wound healing, when adhesions form.¹¹ The original adhesion barriers consisted of omental and peritoneal grafts that were placed over surgical sites. However, studies demonstrated that devitalized tissue positioned on damaged peritoneum serves as a potent substrate—not inhibitor—for adhesions.¹² More recent trials have examined the adhesion-prevention benefit of other types of absorbable and nonabsorbable barriers.

TABLE 2

Pharmacologic agents studied for adhesion prevention in reproductive surgery

TABLE 3

Fluid and barrier adjuvants studied for adhesion reduction after myomectomy

Absorbable barriers

These are largely derivatives of organic materials. Their application to myomectomy may be limited by the requirement for absolute hemostasis at the site of application.

Interceed (Gynecare, a division of Ethicon), which is derived from oxidized regenerated cellulose, is one of the first and most extensively evaluated barriers. A mesh synthetic designed to be placed over injured tissue, it is a derivative of the hemostatic agent Surgicell (Johnson & Johnson, New Brunswick, NJ), with modifications in weave and pore size.

Interceed offers ease of application: It can be cut to the size or shape necessary and requires no suturing. It forms a gelatinous protective layer within 8 hours of placement, and is degraded into monosaccharides and absorbed within 2 weeks.¹³

The use of Interceed has been shown to reduce adhesions following adhesiolysis and ovarian surgery. In a large, multicenter, prospective, randomized trial, it significantly decreased the incidence of adhesion reformation after adnexal adhesiolysis in infertility patients with bilateral tubal disease.¹⁴

In a retrospective series of 38 infertility patients, including 19 patients after myomectomy (13 with the barrier, 6 without), reproductive outcomes were significantly better in the Interceed group, and adhesion development was reduced.¹⁵ Pregnancy rates in the 2 years following surgery were 78% in the Interceed group, compared with 47% in controls. In addition, among 23 patients who had second-look procedures, postoperative adhesions were noted in 38% of the Interceed group, compared with 86% in controls.¹⁵

Seprafilm (hyaluronic acid-film) (Genzyme Corp, Cambridge, Mass) is a bioresorbable membrane derived from sodium hyaluronate and carboxymethylcellulose. It is absorbed from the peritoneal cavity within 1 week and is completely excreted within 1 month.

Its potential for adhesion prevention after abdominal myomectomy was examined by SLL in a multicenter, prospective, randomized, blinded study¹¹ in which 127 women undergoing abdominal myomectomy at 19 institutions were randomized to either Seprafilm or no barrier. In the Seprafilm group, the barrier was wrapped circumferentially around the uterus, covering all uterine defects, at the time of abdominal closure. Clinical outcomes—including vital signs, adverse events (pain, fever, nausea), and abdominal wound complications—were similar in the control and Seprafilm groups.

In this study, the incidence (mean number of sites), severity, and extent (mean area) of uterine adhesions were significantly lower in the Seprafilm-treated patients. The proportion of patients undergoing anterior hysterotomies who were found to have no anterior uterine adhesions was 39% in the Seprafilm group, compared with 6% in the control group. The percentage of patients with at least 1 adnexa totally free of adhesions to the posterior uterus also was higher in the Seprafilm group—48% versus 31%.¹¹

Nonabsorbable barriers

GoreTex Surgical Membrane (W.L. Gore and Associates, Newark, Del) is an inert expanded polytetrafluoroethylene (PTFE) derivative that must be sutured in place. It is of potential utility in myomectomy because its application does not require absolute hemostasis. However, its usefulness and application are limited by the need for later removal.

In a multicenter, randomized, controlled trial exploring its adhesion-preventive properties after myomectomy, the GoreTex membrane significantly outperformed the barrierfree group.¹⁶

In a separate multicenter, randomized clinical trial, the GoreTex membrane was more effective than Interceed in preventing adhesions after pelvic/tubal reconstructive surgery.¹⁷

Yet another multicenter, randomized trial—this one involving 27 women undergoing abdominal myomectomy—used SLL to determine the extent of adhesions and to remove the barrier. The percentage of adhesion-free surgical sites was significantly higher in the GoreTex group: 56% compared with 7% in no-barrier controls.¹⁶

The adhesion scores, determined by the extent (area of involvement), nature (filmy versus opaque), and tenacity (ease of lysis or dissection) of the adhesions, were significantly lower in the GoreTex group.¹⁶

Despite the few prospective, randomized trials, the evidence supports the efficacy of various fluid and barrier adjuvants.

Histologic examination of the removed barriers demonstrated no tissue attachment to the PTFE. Despite these positive findings, however, both fistula formation and graft infection have been reported after placement of a GoreTex barrier.¹⁸

The Shelhigh Pericardial No-React Patch (Herzog Surgical, Sacramento, Calif) is a new nonabsorbable adhesion barrier that was first described in gynecologic use by Pelosi and Pelosi in a case series of 20 patients.¹⁹ Consisting of a 12-cm-diameter patch of glutaraldehyde-treated bovine/porcine pericardium, this product has an excellent safety record as a permanent pericardial substitute in the cardiovascular literature and has been shown to resist calcification and adhesions.

In the Pelosi series, the patch was placed over the uterine fundus and secured by 4 monofilament sutures at the dome of the uterus and the parietal peritoneum.¹⁹ All patients underwent SLL at 6 weeks, and 3 patients also underwent third-look laparoscopy. None of the 20 women had adhesions between the abdominal wall and the bladder, bowel, uterus, or adnexae at SLL. However, minimal adhesions of the ovaries and tubes were found in 7 patients who had undergone posterior hysterotomy. Clinical trials are likely to follow this small pilot study.

Absorbable fluid adjuvants

With barrier adjuvants, optimal benefit is obtained when the physician can predict potential sites of adhesions. This is not a strict requirement with fluid barriers, which is their chief advantage. Among the agents described below, Sepracoat (Genzyme Corp) is available in the United States, while Intergel (Lifecore Biomedical, Chaska, Minn) was withdrawn from the market in March.

Intergel, a 0.5% ferric hyaluronade formulation, is a sterile nonpyrogenic gel of highly purified sodium hyaluronate, which is ionically cross-linked with ferric ion and adjusted to isotonicity with sodium chloride.¹¹ (Hyaluronic acid is a major component of body tissues and fluids such as peritoneal fluid, where it performs physically supportive and mechanically protective roles.)

Johns and colleagues²⁰ studied Intergel in a randomized, multicenter, third-party– blinded, placebo-controlled study. Of the 265 patients who completed the study, 131 were given 300 mL of Intergel and 134 were given lactated Ringer’s solution (the placebo) at the time of their surgery, through the laparoscopic port. When SLL was performed 6 to 12 weeks after surgery, the mean number and severity of adhesions—overall and at the surgical site—were significantly lower in the Intergel group. Adhesions reformed in 91% of those in the control group, compared with 63% in the Intergel group.

In myomectomy patients, the modified American Fertility Society Score, which uses 24 potential adhesion sites, was reduced by 42% in the Intergel group—a statistically significant improvement.²⁰

One major advantage of Intergel is that it reduces adhesion formation at sites distant from the area of application, secondary to its wide intra-abdominal circulation. However, as mentioned above, sales were voluntarily suspended due to post-market reports of tissue adherence, sterile foreign-body reaction, and late-onset pain that sometimes required surgical intervention. In some patients, persistent residual material was noted at the time of subsequent surgery.

Sepracoat (hyaluronic acid-coat) is a dilute solution of 0.4% hyaluronic acid in phosphate-buffered saline. It is bioresorbable, persists at the application site less than 24 hours, and is completely cleared in less than 5 days.

In a prospective, randomized, blinded, placebo-controlled, multicenter study in 1998, Diamond and colleagues compared Sepracoat with a pure phosphate-buffered saline solution in 227 women undergoing gynecologic procedures via laparotomy.²¹ The aim of the study was to assess the efficacy and safety of the fluid at sites without direct surgical trauma or adhesiolysis. Both solutions were warmed to room temperature and injected into the abdominal cavity before the procedure began (250 mL after skin incision). The solution was reapplied after irrigation or every 30 minutes (100 mL), and at the end of the procedure (250 mL) before closure. The maximum volume used was 1,000 mL. After application, the fluid was left 1 minute before suctioning. Patients underwent SLL 40 days later, and adhesions were identified at the initial procedure and at SLL.

In the Sepracoat group, there was a reduction in de novo adhesions at nonsurgical sites by a factor of 2.8. The proportion of sites with de novo adhesions also decreased, and 80% of Sepracoat patients had at least 1 ovary that was adhesion-free compared with 58% of placebo-treated patients. These findings occurred in areas of indirect trauma, demonstrating that Sepracoat limited trauma at tissue injury.²¹

Conclusion

Adhesion prevention is of utmost importance after abdominal myomectomy, especially in patients who desire future fertility. Despite the limited number of prospective, randomized studies, the literature does support the efficacy of various fluid and barrier adjuvants.

Our practice is to use an adjuvant in all abdominal myomectomies. We have long relied on Interceed, which enjoys both ease of application and an excellent safety record. However, as reviewed above, other potentially useful products are available or in development. As ever, the reproductive surgeon should adhere to principles of microsurgery, strive for meticulous hemostasis, and demonstrate respect for tissue integrity.

Dr. DeCherney reports small holdings with Lifecore Biomedical. Drs. Chang and Marin report no affiliations or financial arrangements with any of the manufacturers of products mentioned in this article.

Abdominal myomectomy is the preferred treatment in women with large or numerous intramural myomas, especially in the setting of infertility, recurrent pregnancy loss, and preservation of future fertility.^1,2 However, postoperative adhesions are distressingly common following this procedure, resulting in significant potential morbidity. Fortunately, a number of products can reduce their occurrence. Proper surgical techniques and a thorough knowledge of these products are invaluable in helping reduce the incidence of adhesions.

The association between adhesions and diminished fertility is well-established,^3,4 particularly when peritubal involvement is present (FIGURES 1-3). Abdominopelvic adhesions also contribute to significant chronic pelvic pain, bowel obstruction, and technical difficulty in subsequent surgical or assisted-reproduction procedures.⁵ Unfortunately, most attempts at adhesiolysis meet with less than complete success, since adhesions recur in 55% to 100% of patients (FIGURE 4).⁶ Thus, preventing adhesions in the first place would seem to be key to successful outcomes in abdominal myomectomy.

This article reviews the evidence on various approaches and products. While the number of studies examining each adjuvant in the setting of abdominal myomectomy is limited, the overall evidence supports the safety and efficacy of both liquid and barrier adjuvants.

Adhesions present a significant clinical dilemma after abdominal myomectomy, occurring in 50% to 90% of patients.^5,7 In 1 prospective series of women undergoing second-look laparoscopy (SLL) after myomectomy, adnexal adhesions were noted in 94% of patients with posterior uterine incisions and in 56% of patients with only anterior or fundal incisions; adhesions between the uterus and omentum or bowel occurred in 88% of all patients.⁵

In another study of early SLL following abdominal myomectomy, 83% of patients had adhesions between the surgical site and the bowel or omentum, and 65% had adhesions involving the adnexae.² Removal of large, bulky fibroids (with uterine mass exceeding 13 weeks’ gestational size) resulted in higher adhesion scores than did small myomas. Again, the incidence and severity of adhesions also correlated with location of the uterine incision: Adnexal adhesions were more common after posterior uterine incisions (76%) than after anterior or fundal entries (45%).²

FIGURE 1 Peritubal adhesion

Adhesion at distal end of the fallopian tube. Peritubal involvement often leads to diminished fertility.

FIGURE 2 Adherent structures

Postoperative adhesion between fallopian tube and the uterus.

FIGURE 3 Cyst dissection

Adhesions can follow common surgeries such as paratubal cyst dissection.

FIGURE 4 Recurrent adhesions

Adhesions may recur following adhesiolysis.

Causes of pelvic adhesions

Adhesion prevention requires an understanding of risk factors and maneuvers that increase the likelihood of injury (see “Pathophysiology of adhesion formation”). A number of causes have been proposed, most of them centering on tissue and peritoneal trauma (TABLE 1).

Injury can arise from excessive or rough manipulation of tissue and peritoneal surfaces or from common effects such as cutting, abrasion, and denudation (FIGURE 5). Tissue desiccation or manual blotting may lead to peritoneal desquamation and fibrin deposition.

Exposure of surfaces to intraperitoneal blood in the setting of tissue hypoxia—virtually unavoidable during abdominal myomectomy—disrupts normal fibrinolytic activity, resulting in stimulation of angiogenesis.⁸

Introduction of reactive foreign bodies such as talc powder, residual suture material, and even lint from laparotomy pads can favor adhesion formation. These serve as substrates or niduses of fibrin deposition.

FIGURE 5 Conducive conditions

Raw surface area can become a potent substrate for adhesions.TABLE 1

Proposed causes of adhesion formation

Techniques that may help prevent adhesions

Based on findings from studies of second-look procedures, most physicians advocate avoiding posterior uterine incisions, as well as minimizing the number and extent of incisions, to help reduce the likelihood of adhesion formation. Further, many Ob/Gyns favor removing myomas through as few uterine incisions as possible.⁹ We select anterior hysterotomy sites that enable removal of multiple fibroids, avoiding posterior incisions and the uterotubal junction whenever possible.

Interestingly, reapproximation of peritoneal defects after reproductive surgery (and, probably, myomectomy) does not appear to help prevent adhesions. Tulandi and colleagues¹⁰ examined the clinical and SLL outcomes of peritoneal closure in patients undergoing Pfannenstiel incisions with or without peritoneal closure at the end of the procedure. There was no difference in postoperative complications or wound healing in the 2 groups. At the time of SLL, there was no significant difference in the incidence of adhesion formation at the anterior abdominal wall.

Principles of microsurgery have been adopted by reproductive surgeons to minimize the likelihood of adhesions after myomectomy and gynecologic surgery in general. The basic techniques reflect respect for tissue integrity:

• Gentle handling of tissue, with minimal manipulation of all peritoneal surfaces.
• Meticulous hemostasis. Examine all myomectomy sites to ensure adequate hemostasis prior to closure.
• Continuous irrigation to prevent tissue desiccation. We favor continuous saline irrigation throughout the procedure. We also use only moistened laparotomy sponges and pads, and avoid applying dry gauze to any tissue surface.
• Avoidance of foreign-body introduction. We use only talc-free gloves and remove all residual suture fragments and tissue debris before closure. We also perform copious saline suction-irrigation at the end of the procedure to remove as much residue as possible.
• Use of fine, nonreactive suture. We favor fine, resorbable sutures that incite as little tissue reactivity as possible. For closure of large myomectomy defects, we use braided multifilaments such as Vicryl (polyglactine 910) (Ethicon, Somerville, NJ) or Dexon (polyglycolic acid) (Davis and Geck, Danbury, Conn) for strength and ease of handling. These sutures are absorbed through simple hydrolysis and stimulate less tissue reactivity than do chromic or catgut sutures.

The idea is appealing, but a randomized, blinded comparison of “good” and “bad” microsurgical technique is unlikely, since no one would wish to perform “bad” technique.

With barrier adjuvants, optimal benefit is obtained when the physician can predict potential sites of adhesions.

Wide range of prevention tools has been studied

Many types of agents have been studied in an attempt to reduce postsurgical adhesions after gynecologic surgery. Although most offer little or no benefit (TABLE 2), a few have potential in myomectomy procedures.

Barriers that form mechanical separation (TABLE 3) theoretically physically separate damaged tissues during early peritoneal wound healing, when adhesions form.¹¹ The original adhesion barriers consisted of omental and peritoneal grafts that were placed over surgical sites. However, studies demonstrated that devitalized tissue positioned on damaged peritoneum serves as a potent substrate—not inhibitor—for adhesions.¹² More recent trials have examined the adhesion-prevention benefit of other types of absorbable and nonabsorbable barriers.

TABLE 2

Pharmacologic agents studied for adhesion prevention in reproductive surgery

TABLE 3

Fluid and barrier adjuvants studied for adhesion reduction after myomectomy

Absorbable barriers

These are largely derivatives of organic materials. Their application to myomectomy may be limited by the requirement for absolute hemostasis at the site of application.

Interceed (Gynecare, a division of Ethicon), which is derived from oxidized regenerated cellulose, is one of the first and most extensively evaluated barriers. A mesh synthetic designed to be placed over injured tissue, it is a derivative of the hemostatic agent Surgicell (Johnson & Johnson, New Brunswick, NJ), with modifications in weave and pore size.

Interceed offers ease of application: It can be cut to the size or shape necessary and requires no suturing. It forms a gelatinous protective layer within 8 hours of placement, and is degraded into monosaccharides and absorbed within 2 weeks.¹³

The use of Interceed has been shown to reduce adhesions following adhesiolysis and ovarian surgery. In a large, multicenter, prospective, randomized trial, it significantly decreased the incidence of adhesion reformation after adnexal adhesiolysis in infertility patients with bilateral tubal disease.¹⁴

In a retrospective series of 38 infertility patients, including 19 patients after myomectomy (13 with the barrier, 6 without), reproductive outcomes were significantly better in the Interceed group, and adhesion development was reduced.¹⁵ Pregnancy rates in the 2 years following surgery were 78% in the Interceed group, compared with 47% in controls. In addition, among 23 patients who had second-look procedures, postoperative adhesions were noted in 38% of the Interceed group, compared with 86% in controls.¹⁵

Seprafilm (hyaluronic acid-film) (Genzyme Corp, Cambridge, Mass) is a bioresorbable membrane derived from sodium hyaluronate and carboxymethylcellulose. It is absorbed from the peritoneal cavity within 1 week and is completely excreted within 1 month.

Its potential for adhesion prevention after abdominal myomectomy was examined by SLL in a multicenter, prospective, randomized, blinded study¹¹ in which 127 women undergoing abdominal myomectomy at 19 institutions were randomized to either Seprafilm or no barrier. In the Seprafilm group, the barrier was wrapped circumferentially around the uterus, covering all uterine defects, at the time of abdominal closure. Clinical outcomes—including vital signs, adverse events (pain, fever, nausea), and abdominal wound complications—were similar in the control and Seprafilm groups.

In this study, the incidence (mean number of sites), severity, and extent (mean area) of uterine adhesions were significantly lower in the Seprafilm-treated patients. The proportion of patients undergoing anterior hysterotomies who were found to have no anterior uterine adhesions was 39% in the Seprafilm group, compared with 6% in the control group. The percentage of patients with at least 1 adnexa totally free of adhesions to the posterior uterus also was higher in the Seprafilm group—48% versus 31%.¹¹

Nonabsorbable barriers

GoreTex Surgical Membrane (W.L. Gore and Associates, Newark, Del) is an inert expanded polytetrafluoroethylene (PTFE) derivative that must be sutured in place. It is of potential utility in myomectomy because its application does not require absolute hemostasis. However, its usefulness and application are limited by the need for later removal.

In a multicenter, randomized, controlled trial exploring its adhesion-preventive properties after myomectomy, the GoreTex membrane significantly outperformed the barrierfree group.¹⁶

In a separate multicenter, randomized clinical trial, the GoreTex membrane was more effective than Interceed in preventing adhesions after pelvic/tubal reconstructive surgery.¹⁷

Yet another multicenter, randomized trial—this one involving 27 women undergoing abdominal myomectomy—used SLL to determine the extent of adhesions and to remove the barrier. The percentage of adhesion-free surgical sites was significantly higher in the GoreTex group: 56% compared with 7% in no-barrier controls.¹⁶

The adhesion scores, determined by the extent (area of involvement), nature (filmy versus opaque), and tenacity (ease of lysis or dissection) of the adhesions, were significantly lower in the GoreTex group.¹⁶

Despite the few prospective, randomized trials, the evidence supports the efficacy of various fluid and barrier adjuvants.

Histologic examination of the removed barriers demonstrated no tissue attachment to the PTFE. Despite these positive findings, however, both fistula formation and graft infection have been reported after placement of a GoreTex barrier.¹⁸

The Shelhigh Pericardial No-React Patch (Herzog Surgical, Sacramento, Calif) is a new nonabsorbable adhesion barrier that was first described in gynecologic use by Pelosi and Pelosi in a case series of 20 patients.¹⁹ Consisting of a 12-cm-diameter patch of glutaraldehyde-treated bovine/porcine pericardium, this product has an excellent safety record as a permanent pericardial substitute in the cardiovascular literature and has been shown to resist calcification and adhesions.

In the Pelosi series, the patch was placed over the uterine fundus and secured by 4 monofilament sutures at the dome of the uterus and the parietal peritoneum.¹⁹ All patients underwent SLL at 6 weeks, and 3 patients also underwent third-look laparoscopy. None of the 20 women had adhesions between the abdominal wall and the bladder, bowel, uterus, or adnexae at SLL. However, minimal adhesions of the ovaries and tubes were found in 7 patients who had undergone posterior hysterotomy. Clinical trials are likely to follow this small pilot study.

Absorbable fluid adjuvants

With barrier adjuvants, optimal benefit is obtained when the physician can predict potential sites of adhesions. This is not a strict requirement with fluid barriers, which is their chief advantage. Among the agents described below, Sepracoat (Genzyme Corp) is available in the United States, while Intergel (Lifecore Biomedical, Chaska, Minn) was withdrawn from the market in March.

Intergel, a 0.5% ferric hyaluronade formulation, is a sterile nonpyrogenic gel of highly purified sodium hyaluronate, which is ionically cross-linked with ferric ion and adjusted to isotonicity with sodium chloride.¹¹ (Hyaluronic acid is a major component of body tissues and fluids such as peritoneal fluid, where it performs physically supportive and mechanically protective roles.)

Johns and colleagues²⁰ studied Intergel in a randomized, multicenter, third-party– blinded, placebo-controlled study. Of the 265 patients who completed the study, 131 were given 300 mL of Intergel and 134 were given lactated Ringer’s solution (the placebo) at the time of their surgery, through the laparoscopic port. When SLL was performed 6 to 12 weeks after surgery, the mean number and severity of adhesions—overall and at the surgical site—were significantly lower in the Intergel group. Adhesions reformed in 91% of those in the control group, compared with 63% in the Intergel group.

In myomectomy patients, the modified American Fertility Society Score, which uses 24 potential adhesion sites, was reduced by 42% in the Intergel group—a statistically significant improvement.²⁰

One major advantage of Intergel is that it reduces adhesion formation at sites distant from the area of application, secondary to its wide intra-abdominal circulation. However, as mentioned above, sales were voluntarily suspended due to post-market reports of tissue adherence, sterile foreign-body reaction, and late-onset pain that sometimes required surgical intervention. In some patients, persistent residual material was noted at the time of subsequent surgery.

Sepracoat (hyaluronic acid-coat) is a dilute solution of 0.4% hyaluronic acid in phosphate-buffered saline. It is bioresorbable, persists at the application site less than 24 hours, and is completely cleared in less than 5 days.

In a prospective, randomized, blinded, placebo-controlled, multicenter study in 1998, Diamond and colleagues compared Sepracoat with a pure phosphate-buffered saline solution in 227 women undergoing gynecologic procedures via laparotomy.²¹ The aim of the study was to assess the efficacy and safety of the fluid at sites without direct surgical trauma or adhesiolysis. Both solutions were warmed to room temperature and injected into the abdominal cavity before the procedure began (250 mL after skin incision). The solution was reapplied after irrigation or every 30 minutes (100 mL), and at the end of the procedure (250 mL) before closure. The maximum volume used was 1,000 mL. After application, the fluid was left 1 minute before suctioning. Patients underwent SLL 40 days later, and adhesions were identified at the initial procedure and at SLL.

In the Sepracoat group, there was a reduction in de novo adhesions at nonsurgical sites by a factor of 2.8. The proportion of sites with de novo adhesions also decreased, and 80% of Sepracoat patients had at least 1 ovary that was adhesion-free compared with 58% of placebo-treated patients. These findings occurred in areas of indirect trauma, demonstrating that Sepracoat limited trauma at tissue injury.²¹

Conclusion

Adhesion prevention is of utmost importance after abdominal myomectomy, especially in patients who desire future fertility. Despite the limited number of prospective, randomized studies, the literature does support the efficacy of various fluid and barrier adjuvants.

Our practice is to use an adjuvant in all abdominal myomectomies. We have long relied on Interceed, which enjoys both ease of application and an excellent safety record. However, as reviewed above, other potentially useful products are available or in development. As ever, the reproductive surgeon should adhere to principles of microsurgery, strive for meticulous hemostasis, and demonstrate respect for tissue integrity.

Dr. DeCherney reports small holdings with Lifecore Biomedical. Drs. Chang and Marin report no affiliations or financial arrangements with any of the manufacturers of products mentioned in this article.

Compared with laparotomy, laparoscopic surgery achieves better hemostasis with less blood loss. Not only does this approach avoid an abdominal incision and the trauma associated with traction, manual manipulation, mechanical dissection, and larger tissue pedicles, but its illumination and magnification afford superior anatomical clarity, allowing the surgeon to seal a vessel before it is incised.

Still, keen surgical judgment remains critical—despite the availability of innovative electrosurgical, ultrasonic, and mechanical laparoscopic devices. Incomplete hemostasis or incision of an active vascular core can occur even with ideal application.

This article outlines the key ingredients of hemostasis during laparoscopy, focusing on the following modalities:

• monopolar electrosurgery
• bipolar electrosurgery
• ultrasonic energy

An orderly protocol minimizes risk

The art of surgical hemostasis is preventing vascular trauma while leaving the least-possible collateral tissue damage. When bleeding is encountered, the surgeon’s ability to attain hemostasis using a particular modality depends largely on how well he or she understands its technical aspects. Of course, thorough knowledge of anatomy also is crucial to prevent inadvertent damage to vital structures.

Surgical hemostasis should not be driven by reflex alone. Instead, surgeons should always follow this orderly sequence of steps to minimize risk:

Identify source of bleeding. Before taking any action, make every effort to accurately determine the source of bleeding and its proximity to vital anatomy. Even in the face of active hemorrhage, you can usually identify the bleeders by combining mechanical tamponade (using the jaws of a grasper or the side of a simple metallic probe) with active hydrolavage (using an irrigator-aspirator to break up and remove blood and clots).

Protect vital structures. If the bowel, bladder, or ureter is in close proximity to the bleeder, mobilize that structure sufficiently before applying energy. You can usually protect these entities by using a combination of countertraction and incremental tissue dissection. Whenever the peritoneum is involved, a relaxing incision parallel to the structure of concern also may be useful.

This protocol mandates withholding thermal energy until an orderly sequence of anatomical triage is carried out. Whenever a vital structure cannot be adequately mobilized, make every effort to control hemorrhage by using mechanical tamponade alone for up to 5 minutes. If access to the bleeding site or vessel caliber render pressure-alone unrealistic, employ either a carefully applied thermal energy or a suture ligature. If the surgeon is uncomfortable using either of these, conversion to laparotomy may be warranted.

Inspect vascular sites. Finally, because pneumoperitoneal pressure alone can tamponade venous bleeders—as well as small arterial ones—inspect all vascular sites with and without insufflation before assuming hemostasis is complete.

Monopolar electrosurgery

With conventional electrosurgery, tissue is coagulated when an electric field is applied across it using high-frequency alternating current. Whether cutting or coagulation occurs depends on the rate and extent of thermodynamic effects (FIGURE 1).

Mechanism of coagulation. When tissue comes into contact with the surface of an activated monopolar electrode, a relatively low-current circuit is completed.

• As the tissue is slowly heated to and maintained at temperatures above 50°C, irreversible cellular damage occurs. This is caused by deconfiguration of regulatory proteins and denaturation of cellular proteins.
• If the tissue is heated to 100°C, cellular water completely evaporates (desiccation), localized hemostasis occurs due to contraction of blood vessels and the surrounding tissues (coagulation), and collagens convert to glucose, which creates an adhesive effect between the tissue and electrode.
• Temperatures above 200°C cause carbonization and charring.

Select the best output voltage. Since the output voltage of “coag” current is very high (FIGURE 2), contact coagulation is generally limited to superficial layers. That is because of the accelerated buildup of tissue resistance from rapid desiccation and carbonization. Conversely, electrode contact using the lower-voltage “cut” current heats tissue more gradually, leading to deeper and more reliable penetration. Thus, both contact and coaptive coagulation with monopolar electrosurgery are more effectively performed using “cut” current.

Since superficial-appearing endometriotic implants may extend deeply into the retroperitoneal tissues, I thermally ablate these lesions using a broad-surface electrode in contact with “cut” current. In contrast, I treat superficial implants on the ovarian cortex with “coag” current to minimize unwanted thermal injury to adjacent follicular tissue.

Interrupt the blood flow. Coaptive vessel sealing using any type of monopolar current may be ineffective if the blood flow remains uninterrupted. Unless a vessel is sufficiently squeezed before electricity is applied, current density is dramatically reduced by conduction in blood, and luminal temperatures undergo little change, as any heat is dissipated by convection. Deceived by the appearance of well-coagulated tissue, a surgeon may discover an alarmingly viable core at the time of incision. Regardless of the selected output current (that is, “cut,” “blend,” or “coag”), coaptive desiccation with monopolar electrosurgery is usually insufficient to reliably secure the uterine or ovarian vessels during hysterectomy and oophorectomy.

Achieve the appropriate cutting arc. Electrosurgical cutting (vaporization/ablation) is possible whenever voltage is sufficient to create an electrical spark between an electrode and underlying tissue; tissue cutting is more apt to occur if the arcing remains unabated. When it does, cellular water is superheated to temperatures greater than 600°C, causing explosive vaporization secondary to the production of highly disruptive pressure (since steam occupies 6 times the volume of liquid water).

Although all of the typical output currents (“cut,” “blend,” and “coag”) provide sufficient voltage to ionize the air gap and arc to tissue, the higher voltages of “blend” and “coag” create progressively wider zones of thermal damage at the margins of the incision (FIGURE 3) These effects are amplified by using broad-surface electrodes.

Wide versus narrow hemostasis. Using “blend” or “coag” current to cut in order to provide wider hemostasis can be helpful during myomectomy, as well as when operating down the broad ligament and along the vaginal fornices during hysterectomy, across vascular adhesions, and to clarify the space of Retzius in preparation for colposuspension and paravaginal repair. Higher-voltage currents also facilitate incision of tissues that have greater impedance, such as fatty or desiccated pedicles and adhesions.

On the other hand, it is more prudent to utilize the lower-voltage “cut” current via the edge of an electrode for electrosurgical incision whenever lateral thermal spread may pose extra liability to adjacent tissues, such as the ovarian cortex during cystectomy and the ureter or rectum during excision of endometriosis from the lateral pelvic sidewall or cul-de-sac.

Deceived by the appearance of well-coagulated tissue, surgeons may discover an alarmingly viable core at the time of incision.

• Fulguration is the use of high-voltage sparking produced by “coag” current to coagulate a broad surface with open bleeders. As opposed to the continuous arcing produced by “cut” current, the highly interrupted output of “coag” current causes the arcs to strike the tissue surface in a widely dispersed and random fashion. This leads to more rapid thermal change, creating a zone of superficial coagulation.

I typically employ fulguration to control small bleeders and vessels cut on end along the undersurface of the ovarian cortex during cystectomy, atop the myometrial bed during myomectomy, and alongside Cooper’s ligament during colposuspension.

Protect vital structures with short bursts of “coag” current. If bleeding near the bowel, bladder, or ureter cannot be controlled with pressure alone, carefully directed short bursts of noncontact “coag” current with a broad-surface electrode may help you attain effective hemostasis with the least-possible amount of electrosurgical penetration.

Despite the high-voltage output involved, fulguration is useless in a wet, conductive surgical field due to the random diffusion of current.

FIGURE 2 Range of output voltages

Relative changes in voltage and average current related to “cut,” “blend,” and “coag” currents.

FIGURE 3Zones of thermal damage related to voltage

Using a conventional electrosurgical generator for tissue cutting, the margin of thermal necrosis expands with increasing voltage.

Bipolar electrosurgery

Mechanism of action. Bipolar electrosurgery consolidates an active electrode and return electrode into an instrument with 2 small poles. These poles can be the tines of a forceps, blades of a scissors, or an electrode matched to a more proximal conductive collar separated by an insulator. The output typically used is the low-voltage “cut” current.

Advantages of bipolar energy. Localization of current between the poles offers distinct advantages. Thermal damage is generally limited to a discrete volume of tissue. A bipolar forceps can be used to coapt and thermally weld blood vessels. The concentrated current and small distance between the poles also make it possible to desiccate tissue that is immersed in fluid. This modality is less useful, however, when open blood vessels are retracted or tissue pedicles are very thick.

Because it tends to promote the flow of energy well beyond desiccation, an ammeter should not be used to determine the treatment endpoint for coagulation of blood vessels in the vicinity of vital tissue.

Know when to terminate current to prevent vital-tissue damage. Although the flow of current and primary thermal effects are restricted to the tissue between the poles, this does not eliminate the risk of thermal injury to tissue that is distant from the site of directed hemostasis. As current is applied between the poles, the intervening tissue gradually desiccates until it becomes thoroughly dehydrated. Desiccation is complete when the tissue whitens and visible steam emission stops. If the application of current continues, the heat spreads well beyond the electrical limits of the instrument.

This secondary thermal bloom is caused by the bubbling of steam into the tissue parenchyma as heat is rapidly generated (due to dry tissue’s high resistance to the flow of electrical current). This explains why structures such as the ureter or bowel may suffer irreversible thermal damage despite being at some distance from an operative or bleeding site.

Use of an in-line ammeter does not prevent this problem. Rather, it tends to promote the flow of energy well beyond desiccation. Consequently, an ammeter should not be used to determine the treatment endpoint for coagulation of blood vessels in the vicinity of vital tissue.

Whenever bipolar electrosurgery is used for hemostasis, unwanted thermal damage can be minimized by:

• terminating the flow of current at the end of the visible vapor phase,
• applying current in a pulsatile fashion to permit tissue cooling,
• avoiding the use of an in-line ammeter to determine the coagulation endpoint, and
• securing pedicles by a stepwise process that alternates between partial desiccation and incremental cutting (TABLE 1).

Since the rate of temperature generation is a direct function of the volume of tissue being desiccated, thermal spread can also be reduced by using the sides or tips of a slightly open forceps to press or lift, rather than coapt for hemostasis (FIGURE 4).

Free adherent tissue gently. As with contact monopolar coagulation, tissue between the electrodes of a bipolar instrument may become adherent during desiccation. Repeated attempts to shake the tissue free may lead to traumatic avulsion of a key vascular pedicle. A stuck vascular pedicle can usually be unglued by energizing the opened device while immersing it in a conductive irrigant, such as saline. Once the solution is boiled by the high current density between the electrodes, the mechanical action of bubbling is usually sufficient to atraumatically free the pedicle.

FIGURE 4 Minimizing bipolar thermal damage

Using contact rather than coaptation is one way to limit thermal injury during bipolar electrosurgery.TABLE 1

Minimizing bipolar thermal damage

Ultrasonic energy

Mechanism of action. Ultrasonic shears produce mechanical energy to cut and coagulate tissue. Housed in the hand piece of this laparoscopic device is a piezoelectric crystal that vibrates a titanium blade 55,500 times per second over a variable excursion of 50 microns to 100 microns. As energy is transmitted to tissue, hydrogen bonds of tissue proteins are ruptured, leading to a denatured protein coagulum without significant charring. The tissue cutting that occurs is secondary to mechanical vibration and cavitational fragmentation of tissue parenchyma.

Since ultrasonic energy does not generate the high temperatures created by electrosurgery, it is less dependable for deep-tissue coagulation. Rather, thermal change is gradual, requiring a modicum of patience.

Available instrument configurations include 5-mm curved or hook blades. In addition, 5-mm or 10-mm ligating and cutting shears coaptively desiccate and cut the tissue by securing it between a grooved plastic pad and the vibrating blade.

Tissue effects depend on interplay of factors. By using various combinations of blade shapes, blade excursions, and tissue tensions, surgeons can accomplish a variety of specific effects. Cutting velocity is directly proportional to blade excursion, tissue traction, and blade surface area (energy density), and is inversely related to tissue density and elasticity. Thus, the fastest cutting with the least amount of coagulation occurs when tissue is placed on tension and firmly squeezed, lifted, or rotated with the sharpest side of a blade set at maximum excursion.

Coagulation is the obverse of cutting: It is inversely related to tissue tension, blade sharpness, blade excursion, and cutting speed. Therefore, coagulation is best achieved by relaxing tension, minimizing blade excursion, and using a blunt edge or flattened blade surface.

A stuck vascular pedicle can usually be unglued by energizing the opened bipolar device while immersing it in a conductive irrigant.

Avoid excessive traction and torsion. Be mindful of the potential for premature incision of an incompletely coagulated tissue pedicle when excessive traction or torsion is applied. When used to coaptively desiccate and incise a vascular pedicle, ultrasonic energy should be applied patiently, taking great care to minimize tissue tension while using the broadest blade surface set to the lowest excursion (TABLE 2). Hemostatic incision is best ensured by first coagulating several overlapping areas along an untracted pedicle, limiting each application to the point of tissue blanching and initial vapor emission. Only then should the pedicle be incised by gradually lifting, squeezing, or rotating the distal device. In this fashion, ultrasonic energy can be successfully used to secure both the ovarian and uterine vessels.

TABLE 2

Factors likely to cause premature incision with ultrasonic energy

Summary

The use of electrical and ultrasonic energy during operative laparoscopy poses several challenges, including the reduction of unwanted thermal injury and the elimination of incomplete hemostasis.

Since the depth of penetration during monopolar electrosurgery is proportional to both output voltage and surface area, unwanted thermal change can be reduced by using the smallest electrode surface with “cut” current for tissue cutting, and “coag” current with a broad-surface electrode for contact or noncontact (fulguration) coagulation.

Bipolar electrosurgery is the preferred modality for coaptive desiccation of a vascular pedicle with electricity. Despite the isolation of current to the intervening tissue, surgeons must take steps to reduce the lateral percolation of heat into adjacent tissues.

Ultrasonic energy provides reliable coaptive hemostasis and incision with little tissue damage. However, the surgeon must be mindful of the forces that promulgate premature incision. Knowledge of the biophysical behavior of electrical and ultrasonic energy is a prelude to safety and efficacy during laparoscopic dissection.

Dr. Brill reports no affiliations or financial arrangements with any of the manufacturers of products mentioned in this article.

Compared with laparotomy, laparoscopic surgery achieves better hemostasis with less blood loss. Not only does this approach avoid an abdominal incision and the trauma associated with traction, manual manipulation, mechanical dissection, and larger tissue pedicles, but its illumination and magnification afford superior anatomical clarity, allowing the surgeon to seal a vessel before it is incised.

Still, keen surgical judgment remains critical—despite the availability of innovative electrosurgical, ultrasonic, and mechanical laparoscopic devices. Incomplete hemostasis or incision of an active vascular core can occur even with ideal application.

This article outlines the key ingredients of hemostasis during laparoscopy, focusing on the following modalities:

• monopolar electrosurgery
• bipolar electrosurgery
• ultrasonic energy

An orderly protocol minimizes risk

The art of surgical hemostasis is preventing vascular trauma while leaving the least-possible collateral tissue damage. When bleeding is encountered, the surgeon’s ability to attain hemostasis using a particular modality depends largely on how well he or she understands its technical aspects. Of course, thorough knowledge of anatomy also is crucial to prevent inadvertent damage to vital structures.

Surgical hemostasis should not be driven by reflex alone. Instead, surgeons should always follow this orderly sequence of steps to minimize risk:

Identify source of bleeding. Before taking any action, make every effort to accurately determine the source of bleeding and its proximity to vital anatomy. Even in the face of active hemorrhage, you can usually identify the bleeders by combining mechanical tamponade (using the jaws of a grasper or the side of a simple metallic probe) with active hydrolavage (using an irrigator-aspirator to break up and remove blood and clots).

Protect vital structures. If the bowel, bladder, or ureter is in close proximity to the bleeder, mobilize that structure sufficiently before applying energy. You can usually protect these entities by using a combination of countertraction and incremental tissue dissection. Whenever the peritoneum is involved, a relaxing incision parallel to the structure of concern also may be useful.

This protocol mandates withholding thermal energy until an orderly sequence of anatomical triage is carried out. Whenever a vital structure cannot be adequately mobilized, make every effort to control hemorrhage by using mechanical tamponade alone for up to 5 minutes. If access to the bleeding site or vessel caliber render pressure-alone unrealistic, employ either a carefully applied thermal energy or a suture ligature. If the surgeon is uncomfortable using either of these, conversion to laparotomy may be warranted.

Inspect vascular sites. Finally, because pneumoperitoneal pressure alone can tamponade venous bleeders—as well as small arterial ones—inspect all vascular sites with and without insufflation before assuming hemostasis is complete.

Monopolar electrosurgery

With conventional electrosurgery, tissue is coagulated when an electric field is applied across it using high-frequency alternating current. Whether cutting or coagulation occurs depends on the rate and extent of thermodynamic effects (FIGURE 1).

Mechanism of coagulation. When tissue comes into contact with the surface of an activated monopolar electrode, a relatively low-current circuit is completed.

• As the tissue is slowly heated to and maintained at temperatures above 50°C, irreversible cellular damage occurs. This is caused by deconfiguration of regulatory proteins and denaturation of cellular proteins.
• If the tissue is heated to 100°C, cellular water completely evaporates (desiccation), localized hemostasis occurs due to contraction of blood vessels and the surrounding tissues (coagulation), and collagens convert to glucose, which creates an adhesive effect between the tissue and electrode.
• Temperatures above 200°C cause carbonization and charring.

Select the best output voltage. Since the output voltage of “coag” current is very high (FIGURE 2), contact coagulation is generally limited to superficial layers. That is because of the accelerated buildup of tissue resistance from rapid desiccation and carbonization. Conversely, electrode contact using the lower-voltage “cut” current heats tissue more gradually, leading to deeper and more reliable penetration. Thus, both contact and coaptive coagulation with monopolar electrosurgery are more effectively performed using “cut” current.

Since superficial-appearing endometriotic implants may extend deeply into the retroperitoneal tissues, I thermally ablate these lesions using a broad-surface electrode in contact with “cut” current. In contrast, I treat superficial implants on the ovarian cortex with “coag” current to minimize unwanted thermal injury to adjacent follicular tissue.

Interrupt the blood flow. Coaptive vessel sealing using any type of monopolar current may be ineffective if the blood flow remains uninterrupted. Unless a vessel is sufficiently squeezed before electricity is applied, current density is dramatically reduced by conduction in blood, and luminal temperatures undergo little change, as any heat is dissipated by convection. Deceived by the appearance of well-coagulated tissue, a surgeon may discover an alarmingly viable core at the time of incision. Regardless of the selected output current (that is, “cut,” “blend,” or “coag”), coaptive desiccation with monopolar electrosurgery is usually insufficient to reliably secure the uterine or ovarian vessels during hysterectomy and oophorectomy.

Achieve the appropriate cutting arc. Electrosurgical cutting (vaporization/ablation) is possible whenever voltage is sufficient to create an electrical spark between an electrode and underlying tissue; tissue cutting is more apt to occur if the arcing remains unabated. When it does, cellular water is superheated to temperatures greater than 600°C, causing explosive vaporization secondary to the production of highly disruptive pressure (since steam occupies 6 times the volume of liquid water).

Although all of the typical output currents (“cut,” “blend,” and “coag”) provide sufficient voltage to ionize the air gap and arc to tissue, the higher voltages of “blend” and “coag” create progressively wider zones of thermal damage at the margins of the incision (FIGURE 3) These effects are amplified by using broad-surface electrodes.

Wide versus narrow hemostasis. Using “blend” or “coag” current to cut in order to provide wider hemostasis can be helpful during myomectomy, as well as when operating down the broad ligament and along the vaginal fornices during hysterectomy, across vascular adhesions, and to clarify the space of Retzius in preparation for colposuspension and paravaginal repair. Higher-voltage currents also facilitate incision of tissues that have greater impedance, such as fatty or desiccated pedicles and adhesions.

On the other hand, it is more prudent to utilize the lower-voltage “cut” current via the edge of an electrode for electrosurgical incision whenever lateral thermal spread may pose extra liability to adjacent tissues, such as the ovarian cortex during cystectomy and the ureter or rectum during excision of endometriosis from the lateral pelvic sidewall or cul-de-sac.

Deceived by the appearance of well-coagulated tissue, surgeons may discover an alarmingly viable core at the time of incision.

• Fulguration is the use of high-voltage sparking produced by “coag” current to coagulate a broad surface with open bleeders. As opposed to the continuous arcing produced by “cut” current, the highly interrupted output of “coag” current causes the arcs to strike the tissue surface in a widely dispersed and random fashion. This leads to more rapid thermal change, creating a zone of superficial coagulation.

I typically employ fulguration to control small bleeders and vessels cut on end along the undersurface of the ovarian cortex during cystectomy, atop the myometrial bed during myomectomy, and alongside Cooper’s ligament during colposuspension.

Protect vital structures with short bursts of “coag” current. If bleeding near the bowel, bladder, or ureter cannot be controlled with pressure alone, carefully directed short bursts of noncontact “coag” current with a broad-surface electrode may help you attain effective hemostasis with the least-possible amount of electrosurgical penetration.

Despite the high-voltage output involved, fulguration is useless in a wet, conductive surgical field due to the random diffusion of current.

FIGURE 2 Range of output voltages

Relative changes in voltage and average current related to “cut,” “blend,” and “coag” currents.

FIGURE 3Zones of thermal damage related to voltage

Using a conventional electrosurgical generator for tissue cutting, the margin of thermal necrosis expands with increasing voltage.

Bipolar electrosurgery

Mechanism of action. Bipolar electrosurgery consolidates an active electrode and return electrode into an instrument with 2 small poles. These poles can be the tines of a forceps, blades of a scissors, or an electrode matched to a more proximal conductive collar separated by an insulator. The output typically used is the low-voltage “cut” current.

Advantages of bipolar energy. Localization of current between the poles offers distinct advantages. Thermal damage is generally limited to a discrete volume of tissue. A bipolar forceps can be used to coapt and thermally weld blood vessels. The concentrated current and small distance between the poles also make it possible to desiccate tissue that is immersed in fluid. This modality is less useful, however, when open blood vessels are retracted or tissue pedicles are very thick.

Because it tends to promote the flow of energy well beyond desiccation, an ammeter should not be used to determine the treatment endpoint for coagulation of blood vessels in the vicinity of vital tissue.

Know when to terminate current to prevent vital-tissue damage. Although the flow of current and primary thermal effects are restricted to the tissue between the poles, this does not eliminate the risk of thermal injury to tissue that is distant from the site of directed hemostasis. As current is applied between the poles, the intervening tissue gradually desiccates until it becomes thoroughly dehydrated. Desiccation is complete when the tissue whitens and visible steam emission stops. If the application of current continues, the heat spreads well beyond the electrical limits of the instrument.

This secondary thermal bloom is caused by the bubbling of steam into the tissue parenchyma as heat is rapidly generated (due to dry tissue’s high resistance to the flow of electrical current). This explains why structures such as the ureter or bowel may suffer irreversible thermal damage despite being at some distance from an operative or bleeding site.

Use of an in-line ammeter does not prevent this problem. Rather, it tends to promote the flow of energy well beyond desiccation. Consequently, an ammeter should not be used to determine the treatment endpoint for coagulation of blood vessels in the vicinity of vital tissue.

Whenever bipolar electrosurgery is used for hemostasis, unwanted thermal damage can be minimized by:

• terminating the flow of current at the end of the visible vapor phase,
• applying current in a pulsatile fashion to permit tissue cooling,
• avoiding the use of an in-line ammeter to determine the coagulation endpoint, and
• securing pedicles by a stepwise process that alternates between partial desiccation and incremental cutting (TABLE 1).

Since the rate of temperature generation is a direct function of the volume of tissue being desiccated, thermal spread can also be reduced by using the sides or tips of a slightly open forceps to press or lift, rather than coapt for hemostasis (FIGURE 4).

Free adherent tissue gently. As with contact monopolar coagulation, tissue between the electrodes of a bipolar instrument may become adherent during desiccation. Repeated attempts to shake the tissue free may lead to traumatic avulsion of a key vascular pedicle. A stuck vascular pedicle can usually be unglued by energizing the opened device while immersing it in a conductive irrigant, such as saline. Once the solution is boiled by the high current density between the electrodes, the mechanical action of bubbling is usually sufficient to atraumatically free the pedicle.

FIGURE 4 Minimizing bipolar thermal damage

Using contact rather than coaptation is one way to limit thermal injury during bipolar electrosurgery.TABLE 1

Minimizing bipolar thermal damage

Ultrasonic energy

Mechanism of action. Ultrasonic shears produce mechanical energy to cut and coagulate tissue. Housed in the hand piece of this laparoscopic device is a piezoelectric crystal that vibrates a titanium blade 55,500 times per second over a variable excursion of 50 microns to 100 microns. As energy is transmitted to tissue, hydrogen bonds of tissue proteins are ruptured, leading to a denatured protein coagulum without significant charring. The tissue cutting that occurs is secondary to mechanical vibration and cavitational fragmentation of tissue parenchyma.

Since ultrasonic energy does not generate the high temperatures created by electrosurgery, it is less dependable for deep-tissue coagulation. Rather, thermal change is gradual, requiring a modicum of patience.

Available instrument configurations include 5-mm curved or hook blades. In addition, 5-mm or 10-mm ligating and cutting shears coaptively desiccate and cut the tissue by securing it between a grooved plastic pad and the vibrating blade.

Tissue effects depend on interplay of factors. By using various combinations of blade shapes, blade excursions, and tissue tensions, surgeons can accomplish a variety of specific effects. Cutting velocity is directly proportional to blade excursion, tissue traction, and blade surface area (energy density), and is inversely related to tissue density and elasticity. Thus, the fastest cutting with the least amount of coagulation occurs when tissue is placed on tension and firmly squeezed, lifted, or rotated with the sharpest side of a blade set at maximum excursion.

Coagulation is the obverse of cutting: It is inversely related to tissue tension, blade sharpness, blade excursion, and cutting speed. Therefore, coagulation is best achieved by relaxing tension, minimizing blade excursion, and using a blunt edge or flattened blade surface.

A stuck vascular pedicle can usually be unglued by energizing the opened bipolar device while immersing it in a conductive irrigant.

Avoid excessive traction and torsion. Be mindful of the potential for premature incision of an incompletely coagulated tissue pedicle when excessive traction or torsion is applied. When used to coaptively desiccate and incise a vascular pedicle, ultrasonic energy should be applied patiently, taking great care to minimize tissue tension while using the broadest blade surface set to the lowest excursion (TABLE 2). Hemostatic incision is best ensured by first coagulating several overlapping areas along an untracted pedicle, limiting each application to the point of tissue blanching and initial vapor emission. Only then should the pedicle be incised by gradually lifting, squeezing, or rotating the distal device. In this fashion, ultrasonic energy can be successfully used to secure both the ovarian and uterine vessels.

TABLE 2

Factors likely to cause premature incision with ultrasonic energy

Summary

The use of electrical and ultrasonic energy during operative laparoscopy poses several challenges, including the reduction of unwanted thermal injury and the elimination of incomplete hemostasis.

Since the depth of penetration during monopolar electrosurgery is proportional to both output voltage and surface area, unwanted thermal change can be reduced by using the smallest electrode surface with “cut” current for tissue cutting, and “coag” current with a broad-surface electrode for contact or noncontact (fulguration) coagulation.

Bipolar electrosurgery is the preferred modality for coaptive desiccation of a vascular pedicle with electricity. Despite the isolation of current to the intervening tissue, surgeons must take steps to reduce the lateral percolation of heat into adjacent tissues.

Ultrasonic energy provides reliable coaptive hemostasis and incision with little tissue damage. However, the surgeon must be mindful of the forces that promulgate premature incision. Knowledge of the biophysical behavior of electrical and ultrasonic energy is a prelude to safety and efficacy during laparoscopic dissection.

Dr. Brill reports no affiliations or financial arrangements with any of the manufacturers of products mentioned in this article.

Compared with laparotomy, laparoscopic surgery achieves better hemostasis with less blood loss. Not only does this approach avoid an abdominal incision and the trauma associated with traction, manual manipulation, mechanical dissection, and larger tissue pedicles, but its illumination and magnification afford superior anatomical clarity, allowing the surgeon to seal a vessel before it is incised.

Still, keen surgical judgment remains critical—despite the availability of innovative electrosurgical, ultrasonic, and mechanical laparoscopic devices. Incomplete hemostasis or incision of an active vascular core can occur even with ideal application.

This article outlines the key ingredients of hemostasis during laparoscopy, focusing on the following modalities:

• monopolar electrosurgery
• bipolar electrosurgery
• ultrasonic energy

An orderly protocol minimizes risk

The art of surgical hemostasis is preventing vascular trauma while leaving the least-possible collateral tissue damage. When bleeding is encountered, the surgeon’s ability to attain hemostasis using a particular modality depends largely on how well he or she understands its technical aspects. Of course, thorough knowledge of anatomy also is crucial to prevent inadvertent damage to vital structures.

Surgical hemostasis should not be driven by reflex alone. Instead, surgeons should always follow this orderly sequence of steps to minimize risk:

Identify source of bleeding. Before taking any action, make every effort to accurately determine the source of bleeding and its proximity to vital anatomy. Even in the face of active hemorrhage, you can usually identify the bleeders by combining mechanical tamponade (using the jaws of a grasper or the side of a simple metallic probe) with active hydrolavage (using an irrigator-aspirator to break up and remove blood and clots).

Protect vital structures. If the bowel, bladder, or ureter is in close proximity to the bleeder, mobilize that structure sufficiently before applying energy. You can usually protect these entities by using a combination of countertraction and incremental tissue dissection. Whenever the peritoneum is involved, a relaxing incision parallel to the structure of concern also may be useful.

This protocol mandates withholding thermal energy until an orderly sequence of anatomical triage is carried out. Whenever a vital structure cannot be adequately mobilized, make every effort to control hemorrhage by using mechanical tamponade alone for up to 5 minutes. If access to the bleeding site or vessel caliber render pressure-alone unrealistic, employ either a carefully applied thermal energy or a suture ligature. If the surgeon is uncomfortable using either of these, conversion to laparotomy may be warranted.

Inspect vascular sites. Finally, because pneumoperitoneal pressure alone can tamponade venous bleeders—as well as small arterial ones—inspect all vascular sites with and without insufflation before assuming hemostasis is complete.

Monopolar electrosurgery

With conventional electrosurgery, tissue is coagulated when an electric field is applied across it using high-frequency alternating current. Whether cutting or coagulation occurs depends on the rate and extent of thermodynamic effects (FIGURE 1).

Mechanism of coagulation. When tissue comes into contact with the surface of an activated monopolar electrode, a relatively low-current circuit is completed.

• As the tissue is slowly heated to and maintained at temperatures above 50°C, irreversible cellular damage occurs. This is caused by deconfiguration of regulatory proteins and denaturation of cellular proteins.
• If the tissue is heated to 100°C, cellular water completely evaporates (desiccation), localized hemostasis occurs due to contraction of blood vessels and the surrounding tissues (coagulation), and collagens convert to glucose, which creates an adhesive effect between the tissue and electrode.
• Temperatures above 200°C cause carbonization and charring.

Select the best output voltage. Since the output voltage of “coag” current is very high (FIGURE 2), contact coagulation is generally limited to superficial layers. That is because of the accelerated buildup of tissue resistance from rapid desiccation and carbonization. Conversely, electrode contact using the lower-voltage “cut” current heats tissue more gradually, leading to deeper and more reliable penetration. Thus, both contact and coaptive coagulation with monopolar electrosurgery are more effectively performed using “cut” current.

Since superficial-appearing endometriotic implants may extend deeply into the retroperitoneal tissues, I thermally ablate these lesions using a broad-surface electrode in contact with “cut” current. In contrast, I treat superficial implants on the ovarian cortex with “coag” current to minimize unwanted thermal injury to adjacent follicular tissue.

Interrupt the blood flow. Coaptive vessel sealing using any type of monopolar current may be ineffective if the blood flow remains uninterrupted. Unless a vessel is sufficiently squeezed before electricity is applied, current density is dramatically reduced by conduction in blood, and luminal temperatures undergo little change, as any heat is dissipated by convection. Deceived by the appearance of well-coagulated tissue, a surgeon may discover an alarmingly viable core at the time of incision. Regardless of the selected output current (that is, “cut,” “blend,” or “coag”), coaptive desiccation with monopolar electrosurgery is usually insufficient to reliably secure the uterine or ovarian vessels during hysterectomy and oophorectomy.

Achieve the appropriate cutting arc. Electrosurgical cutting (vaporization/ablation) is possible whenever voltage is sufficient to create an electrical spark between an electrode and underlying tissue; tissue cutting is more apt to occur if the arcing remains unabated. When it does, cellular water is superheated to temperatures greater than 600°C, causing explosive vaporization secondary to the production of highly disruptive pressure (since steam occupies 6 times the volume of liquid water).

Although all of the typical output currents (“cut,” “blend,” and “coag”) provide sufficient voltage to ionize the air gap and arc to tissue, the higher voltages of “blend” and “coag” create progressively wider zones of thermal damage at the margins of the incision (FIGURE 3) These effects are amplified by using broad-surface electrodes.

Wide versus narrow hemostasis. Using “blend” or “coag” current to cut in order to provide wider hemostasis can be helpful during myomectomy, as well as when operating down the broad ligament and along the vaginal fornices during hysterectomy, across vascular adhesions, and to clarify the space of Retzius in preparation for colposuspension and paravaginal repair. Higher-voltage currents also facilitate incision of tissues that have greater impedance, such as fatty or desiccated pedicles and adhesions.

On the other hand, it is more prudent to utilize the lower-voltage “cut” current via the edge of an electrode for electrosurgical incision whenever lateral thermal spread may pose extra liability to adjacent tissues, such as the ovarian cortex during cystectomy and the ureter or rectum during excision of endometriosis from the lateral pelvic sidewall or cul-de-sac.

Deceived by the appearance of well-coagulated tissue, surgeons may discover an alarmingly viable core at the time of incision.

• Fulguration is the use of high-voltage sparking produced by “coag” current to coagulate a broad surface with open bleeders. As opposed to the continuous arcing produced by “cut” current, the highly interrupted output of “coag” current causes the arcs to strike the tissue surface in a widely dispersed and random fashion. This leads to more rapid thermal change, creating a zone of superficial coagulation.

I typically employ fulguration to control small bleeders and vessels cut on end along the undersurface of the ovarian cortex during cystectomy, atop the myometrial bed during myomectomy, and alongside Cooper’s ligament during colposuspension.

Protect vital structures with short bursts of “coag” current. If bleeding near the bowel, bladder, or ureter cannot be controlled with pressure alone, carefully directed short bursts of noncontact “coag” current with a broad-surface electrode may help you attain effective hemostasis with the least-possible amount of electrosurgical penetration.

Despite the high-voltage output involved, fulguration is useless in a wet, conductive surgical field due to the random diffusion of current.

FIGURE 2 Range of output voltages

Relative changes in voltage and average current related to “cut,” “blend,” and “coag” currents.

FIGURE 3Zones of thermal damage related to voltage

Using a conventional electrosurgical generator for tissue cutting, the margin of thermal necrosis expands with increasing voltage.

Bipolar electrosurgery

Mechanism of action. Bipolar electrosurgery consolidates an active electrode and return electrode into an instrument with 2 small poles. These poles can be the tines of a forceps, blades of a scissors, or an electrode matched to a more proximal conductive collar separated by an insulator. The output typically used is the low-voltage “cut” current.

Advantages of bipolar energy. Localization of current between the poles offers distinct advantages. Thermal damage is generally limited to a discrete volume of tissue. A bipolar forceps can be used to coapt and thermally weld blood vessels. The concentrated current and small distance between the poles also make it possible to desiccate tissue that is immersed in fluid. This modality is less useful, however, when open blood vessels are retracted or tissue pedicles are very thick.

Because it tends to promote the flow of energy well beyond desiccation, an ammeter should not be used to determine the treatment endpoint for coagulation of blood vessels in the vicinity of vital tissue.

Know when to terminate current to prevent vital-tissue damage. Although the flow of current and primary thermal effects are restricted to the tissue between the poles, this does not eliminate the risk of thermal injury to tissue that is distant from the site of directed hemostasis. As current is applied between the poles, the intervening tissue gradually desiccates until it becomes thoroughly dehydrated. Desiccation is complete when the tissue whitens and visible steam emission stops. If the application of current continues, the heat spreads well beyond the electrical limits of the instrument.

This secondary thermal bloom is caused by the bubbling of steam into the tissue parenchyma as heat is rapidly generated (due to dry tissue’s high resistance to the flow of electrical current). This explains why structures such as the ureter or bowel may suffer irreversible thermal damage despite being at some distance from an operative or bleeding site.

Use of an in-line ammeter does not prevent this problem. Rather, it tends to promote the flow of energy well beyond desiccation. Consequently, an ammeter should not be used to determine the treatment endpoint for coagulation of blood vessels in the vicinity of vital tissue.

Whenever bipolar electrosurgery is used for hemostasis, unwanted thermal damage can be minimized by:

• terminating the flow of current at the end of the visible vapor phase,
• applying current in a pulsatile fashion to permit tissue cooling,
• avoiding the use of an in-line ammeter to determine the coagulation endpoint, and
• securing pedicles by a stepwise process that alternates between partial desiccation and incremental cutting (TABLE 1).

Since the rate of temperature generation is a direct function of the volume of tissue being desiccated, thermal spread can also be reduced by using the sides or tips of a slightly open forceps to press or lift, rather than coapt for hemostasis (FIGURE 4).

Free adherent tissue gently. As with contact monopolar coagulation, tissue between the electrodes of a bipolar instrument may become adherent during desiccation. Repeated attempts to shake the tissue free may lead to traumatic avulsion of a key vascular pedicle. A stuck vascular pedicle can usually be unglued by energizing the opened device while immersing it in a conductive irrigant, such as saline. Once the solution is boiled by the high current density between the electrodes, the mechanical action of bubbling is usually sufficient to atraumatically free the pedicle.

FIGURE 4 Minimizing bipolar thermal damage

Using contact rather than coaptation is one way to limit thermal injury during bipolar electrosurgery.TABLE 1

Minimizing bipolar thermal damage

Ultrasonic energy

Mechanism of action. Ultrasonic shears produce mechanical energy to cut and coagulate tissue. Housed in the hand piece of this laparoscopic device is a piezoelectric crystal that vibrates a titanium blade 55,500 times per second over a variable excursion of 50 microns to 100 microns. As energy is transmitted to tissue, hydrogen bonds of tissue proteins are ruptured, leading to a denatured protein coagulum without significant charring. The tissue cutting that occurs is secondary to mechanical vibration and cavitational fragmentation of tissue parenchyma.

Since ultrasonic energy does not generate the high temperatures created by electrosurgery, it is less dependable for deep-tissue coagulation. Rather, thermal change is gradual, requiring a modicum of patience.

Available instrument configurations include 5-mm curved or hook blades. In addition, 5-mm or 10-mm ligating and cutting shears coaptively desiccate and cut the tissue by securing it between a grooved plastic pad and the vibrating blade.

Tissue effects depend on interplay of factors. By using various combinations of blade shapes, blade excursions, and tissue tensions, surgeons can accomplish a variety of specific effects. Cutting velocity is directly proportional to blade excursion, tissue traction, and blade surface area (energy density), and is inversely related to tissue density and elasticity. Thus, the fastest cutting with the least amount of coagulation occurs when tissue is placed on tension and firmly squeezed, lifted, or rotated with the sharpest side of a blade set at maximum excursion.

Coagulation is the obverse of cutting: It is inversely related to tissue tension, blade sharpness, blade excursion, and cutting speed. Therefore, coagulation is best achieved by relaxing tension, minimizing blade excursion, and using a blunt edge or flattened blade surface.

A stuck vascular pedicle can usually be unglued by energizing the opened bipolar device while immersing it in a conductive irrigant.

Avoid excessive traction and torsion. Be mindful of the potential for premature incision of an incompletely coagulated tissue pedicle when excessive traction or torsion is applied. When used to coaptively desiccate and incise a vascular pedicle, ultrasonic energy should be applied patiently, taking great care to minimize tissue tension while using the broadest blade surface set to the lowest excursion (TABLE 2). Hemostatic incision is best ensured by first coagulating several overlapping areas along an untracted pedicle, limiting each application to the point of tissue blanching and initial vapor emission. Only then should the pedicle be incised by gradually lifting, squeezing, or rotating the distal device. In this fashion, ultrasonic energy can be successfully used to secure both the ovarian and uterine vessels.

TABLE 2

Factors likely to cause premature incision with ultrasonic energy

Summary

The use of electrical and ultrasonic energy during operative laparoscopy poses several challenges, including the reduction of unwanted thermal injury and the elimination of incomplete hemostasis.

Since the depth of penetration during monopolar electrosurgery is proportional to both output voltage and surface area, unwanted thermal change can be reduced by using the smallest electrode surface with “cut” current for tissue cutting, and “coag” current with a broad-surface electrode for contact or noncontact (fulguration) coagulation.

Bipolar electrosurgery is the preferred modality for coaptive desiccation of a vascular pedicle with electricity. Despite the isolation of current to the intervening tissue, surgeons must take steps to reduce the lateral percolation of heat into adjacent tissues.

Ultrasonic energy provides reliable coaptive hemostasis and incision with little tissue damage. However, the surgeon must be mindful of the forces that promulgate premature incision. Knowledge of the biophysical behavior of electrical and ultrasonic energy is a prelude to safety and efficacy during laparoscopic dissection.

Dr. Brill reports no affiliations or financial arrangements with any of the manufacturers of products mentioned in this article.

Although laparoscopic hysterectomy offers a minimally invasive alternative to laparotomy when vaginal hysterectomy is contraindicated, it has its drawbacks. Among them: the cost of expensive equipment, the long learning curve, and prolonged operating time.

We describe another alternative to open surgery that is comparable to laparoscopic hysterectomy in postoperative pain, cosmetic results, and time to return to normal activities. Our procedure—a redesigned minilaparotomy hysterectomy—relies on traditional open techniques and inexpensive novel instrumentation, making it significantly faster than laparoscopy and easy to perform and teach.

For patients who cannot undergo vaginal hysterectomy, this new modality offers an expeditious, minimal-access option. Gynecologists reluctant to relinquish the routine use of standard laparotomy may find this approach an appealing, less-invasive alternative.

Position, incision, and retraction are crucial to success

Our minilaparotomy hysterectomy is a systemized approach with elements derived from both open and laparoscopic surgery. Three preparatory components are involved:

• position
• incision
• retraction

All are critical to a successful hysterectomy, ensuring that the procedure never becomes a haphazard struggle through an improvised, scaled-down, conventional Pfannenstiel or vertical incision. Our approach also avoids cumbersome traditional laparotomy exposure maneuvers and positioning.

Position: Modified lithotomy. After regional or general anesthesia is given, position the patient in a modified lithotomy with both arms tucked as for laparoscopic surgery. Place the legs in boot-type stirrups, with no hip flexion and sufficient thigh abduction to expose the vagina.

Next, perform a thorough pelvic examination and place an indwelling, transurethral catheter. A sturdy, hinged uterine manipulator is of paramount importance for the hysterectomy, as it facilitates exposure of the adnexa as well as elevation/rotation of the uterus and the uterine attachments. We recommend the Pelosi Uterine Manipulator (Apple Medical Corporation, Marlboro, Mass) or its equivalent (FIGURE 1).

Incision: Modified Kustner’s. Open the abdomen with a cruciate incision. Using a conventional scalpel and the Bovie device, make a 2.5-cm to 5-cm transverse incision through the skin and subcutaneous fat until you reach the anterior rectus fascia (FIGURE 2A). Clear the fat from the midline superiorly and inferiorly to expose approximately 5 cm to 6 cm of fascia in the vertical axis. Then incise the anterior rectus fascia in a vertical direction through the full length of the cleared area (FIGURE 2B).

Retract the rectus muscles from the midline, exposing the transversalis fascia and the underlying peritoneum. Enter the peritoneum digitally or with scissors above the level of the bladder dome, incising vertically until the entrance extends the full length of the fascial incision (FIGURE 2C).

This modified Kustner’s incision is essentially a vertical midline incision in its deeper layers.¹ The rapid surgical dissection of the fascia and rectus muscles and the intraperitoneal entry are relatively bloodless. This approach yields a surgical exposure superior to that of a small Pfannenstiel or Maylard incision.

Note that, in some patients, a vertical incision can be selected if there is a prior vertical incision or if the perioperative workup suggests a malignancy that may require a later extension of the original minilaparotomy incision.

Retraction: Soft, sleeve-type, self-retaining abdominal retractor. This device consists of a flexible plastic inner ring and a firmer outer ring connected by a soft plastic sleeve (FIGURE 3A). Two models are available: the Mobius (Apple Medical Corporation) and the Protractor (Weck Closure Systems, Research Triangle Park, NC).

Squeeze the inner ring into the peritoneal cavity through the minilaparotomy incision, allowing it to spring open against the parietal peritoneum. Conduct a digital assessment to ensure that no viscera are trapped by elevating the outer ring. Next, roll the outer ring onto the sleeve, collecting excess length, until it sits firmly against the skin (FIGURES 3B and 3C). The result, when there is adequate tension within the sleeve, is a circular area of retraction offering excellent exposure of the pelvis. Note that during surgery you may need to adjust the outer ring if the sleeve loosens.

The soft, self-retaining abdominal retractor offers several advantages over traditional abdominal retraction:

• Atraumatic retraction. This device distributes retraction force evenly around the entire incision. Because standard retractors concentrate retraction force at only a few points, they often lead to tissue trauma, nerve damage, bruising, and postoperative pain.
• Incision protection. The retractor’s flexible material lines the incision, protecting the wound’s edges from contamination and potential implantation of malignant cells.
• Improved access. Because the continuous retraction force is delivered more effectively to the incision, exposure is maximized. As a result, the need for intensive surgical assistance is dramatically reduced.
• Adjustable height. The retractor’s design lets it adapt to wounds of varying depth—a feature that makes it ideal for obese patients. The device compresses the patient’s skin and peritoneum between the external and internal rings, keeping the full thickness of the abdominal incision constant throughout the surgery.
• Cost-effectiveness. The device, which costs under $100, is simple and fast to set up. In our experience, placement takes approximately 2 minutes; this compares favorably with table-mounted or self-retaining rigid retraction systems, which may require significant capital expenditures (cost may run in the thousands), repair costs, and complicated set-ups.

FIGURE 1 Hinged uterine manipulator

A sturdy hinged uterine manipulator facilitates exposure of the adnexa as well as elevation/rotation of the uterus.

FIGURE 2 Cruciate incision

A. Make a transverse incision suprapubically through the skin and the subcutaneous fat to reach the anterior rectus fascia.

FIGURE 2 Cruciate incision

B. Clear the fat from the midline to expose the rectus fascia in the vertical axis, then incise the fascia in a vertical direction through the full length of the previously cleared area. The rectus muscles are retracted, thereby exposing the peritoneum.

FIGURE 2 Cruciate incision

C. Incise the peritoneum vertically until it extends the full length of the fascial incision.

FIGURE 3 Soft, sleeve-type, self-retaining abdominal retractor

A. At left, the Protractor (Weck Closure Systems); at right, the Mobius (Apple Medical Corporation).

FIGURE 3 Soft, sleeve-type, self-retaining abdominal retractor

B. After inserting the inner ring into the peritoneal cavity, twist the outer ring downward until it inverts and rests snuggly against the skin.

FIGURE 3 Soft, sleeve-type, self-retaining abdominal retractor

C. An atraumatic, circular, self-retaining area of retraction is created.

Standard technique: Exteriorize the uterus; divide uterine attachments, vessels

Assess the anatomy. Using your index finger and the uterine manipulator to rotate and flex the uterus, carefully assess the uterus, adnexa, and pelvis, noting the location of the ureters. Determine the extent of any unexpected pelvic pathology or adhesions, using traditional small retractors or gentle packing to gain additional exposure. Perform any adhesiolysis that is necessary.

Exteriorize the uterus. Next, bring the uterus and the adnexa above the abdominal wall in order to perform as much of the hysterectomy extracorporeally as possible. Pass the uterus or adnexa through the incision with the upward assistance of the uterine manipulator, then divide the upper uterine attachments (FIGURE 4A).

Increase exposure. You can achieve additional uterine elevation and targeted exposure in several ways. For example, a strong traction suture can be placed in the uterine fundus, left long, and secured with a clamp. To achieve uterine elevation, place long clamps lateral to the corpus. Another effective approach is to place a heavy tenaculum on the uterine fundus.

When lateral exposure is limited, divide the proximal adnexal pedicles and round ligaments to begin the operation, and remove the adnexa separately following the completion of the hysterectomy.

Divide the uterine vessels through the small incision using clamping, division, and ligation. Unless you intend to preserve the cervix, mobilize the bladder to the level of the anterior vaginal fornix. Inward pressure on the uterine manipulator provides additional elevation of the lower uterine vasculature and the cardinal and uterosacral ligaments as these structures are ligated and divided. Amputate the uterine specimen from the vaginal cuff using the uterine manipulator to guide the vaginal circumcision (FIGURE 4B). Close the vaginal cuff using standard closure.

If the cervix is to be preserved, amputate the uterus supracervically following division of the uterine vessels. Then suture the cervical stump in the traditional fashion. Upward elevation of the cervix using the uterine manipulator expedites this step.

Complete the procedure. Once the surgery is completed, remove the retractor, hooking the bottom ring by inserting a finger into it and pulling it up and out of the incision (FIGURE 4C). Closing a cruciate incision is faster and requires less exposure than closing a mini-Pfannenstiel incision. Eliminate the possibility of postoperative wound hematoma or seroma formation by applying a vertical pressure dressing over the incision (FIGURE 4D). Remove the dressing 24 hours later.

FIGURE 4 Hysterectomy for the normal to moderately enlarged uterus

A. Exteriorize the uterus as much as possible with both upward assistance of the manipulator and uterine fundal elevation (using clamps lateral to the uterus, a heavy tenaculum, or a traction suture). Then conduct a standard hysterectomy.

FIGURE 4 Hysterectomy for the normal to moderately enlarged uterus

B. Separate the uterus from the vagina using the manipulator to guide the vaginal circumcision. (If the cervix is to be preserved, a supracervical amputation is performed instead.)

FIGURE 4 Hysterectomy for the normal to moderately enlarged uterus

C. After completing the surgery, remove the retractor from the incision.

FIGURE 4 Hysterectomy for the normal to moderately enlarged uterus

D. Apply a vertical pressure dressing over the incision.

Variations for abnormal uteri

The large fibroid uterus: Begin with the dominant myoma. A large fibroid uterus can be easily removed with our minilaparotomy technique using 3 basic steps:

1. Reduce size by selective myomectomy.
2. Deliver the debulked uterus through the abdominal incision.
3. Perform extracorporeal hysterectomy.

First, you must conduct a thorough assessment of the number, size, and location of the myomas. Begin the myomectomy on the largest tumor of those closest to the minilaparotomy incision. (Minimize bleeding by injecting diluted vasopressin subserosally prior to the procedure.)

Incise the uterine serosa, myometrium, and pseudocapsule of the myoma via scalpel or Bovie electrocautery until the whorly appearance of the myoma is apparent. Next, grasp the myoma with claw-toothed forceps to stabilize it and place it under traction. Then, using a combination of sharp and digital dissection, develop a plane of dissection between the fibroid and the myometrium (FIGURE 5A).

After securing the dominant myoma, deliver it through the abdominal incision. If the myoma is too large to be removed intact from the abdominal cavity, morcellate it using a scalpel or scissors (FIGURE 5B). Then continue systematic removal of the remaining myomas using the same approach. It is not necessary to remove all myomas—the goal of this process is merely to permit delivery of the uterine body for subsequent hysterectomy.

Once the uterus is debulked, deliver it through the abdominal incision. Hysterectomy then is easily completed (FIGURE 5C).

The ‘solid’ uterus: In situ supracervical hysterectomy and uterine morcellation.

Very large uteri are sometimes homogeneous and solid in nature, possessing few or no individual myomas. This so-called cannonball fibroid uterus is the most challenging type of uterus to remove. The selective-myomectomy approach cannot be used because of the potential for massive bleeding and the technical anatomical difficulties that arise when operating through such a small abdominal incision.

Instead, manage this type of uterus by performing a deliberate in situ supracervical hysterectomy through the minilaparotomy incision. At the end of this procedure, morcellate the amputated fibroid uterus.

Begin the surgery by dividing the upper uterine attachments. Regardless of uterine size, the origins of the round and adnexal ligaments will always be lateral to and within easy reach of a transverse minilaparotomy incision. (Access to these areas is the only factor that determines the feasibility of this procedure; uterine size is completely irrelevant.) We have found that these elongated ligaments are quite lax. Thus, in most cases it is relatively simple to navigate your index finger laterally and, using digital traction, elevate these structures into the minilaparotomy incision (FIGURE 6A). You can then clamp, cut, and suture the ligaments in the standard fashion in whatever sequence is most efficient.

Thanks to the retractor, minimal assistance is necessary during the surgery. You can create additional exposure by deflecting the uterus toward the opposite side of the pelvis using external abdominal pressure and the uterine manipulator.

Once both round ligaments and adnexal pedicles are divided, dissect the bladder flap to expose the uterine arteries (inward pressure on the uterine manipulator provides helpful countertraction). Then clamp, divide, and ligate the uterine arteries (FIGURE 6B).

The uterus is now ready for supracervical amputation. Upward traction on the isthmus by means of a rubber tourniquet facilitates uterine division (FIGURE 6C). After the uterus is amputated, push it toward the upper abdomen to increase exposure for suturing of the cervical stump (if the cervix is preserved) or for cervical excision and vaginal cuff closure (when total hysterectomy is chosen).

Next, remove the uterine specimen by morcellation through the minilaparotomy incision. Using the Doyen ladder-shaped uterine morcellation technique (originally described in the early 1920s) grasp an area of the uterus and, alternating right and left, make deep but incomplete incisions on the uterus, creating a ladder shape.² Because of its elasticity, the retractor can stretch quite significantly without tearing the edges of the abdominal incision (FIGURE 6D). This allows the easy exteriorization of uteri with diameters considerably larger than that of the retractor, mimicking the stretching of the perineum during the crowning of the fetal head.

When the surgery is complete, remove the retractor, close the minilaparotomy incision, and apply a vertical pressure dressing over the incision. Neither vaginal packing nor bladder catheterization is required.

FIGURE 5 Hysterectomy for the fibroid uterus

A. Develop a plane of dissection between the myoma and myometrium.

FIGURE 5 Hysterectomy for the fibroid uterus

B. Deliver the myoma through the incision; if it is too large to remove intact, morcellate it with a scalpel or scissors.

FIGURE 5 Hysterectomy for the fibroid uterus

C. After reducing the uterine size by selective myomectomy, deliver the debulked uterus through the abdominal incision. Then proceed with an extracorporeal total or subtotal hysterectomy.

A short learning curve

Since it uses conventional open techniques and traditional instrumentation, this method can be learned and mastered quickly.

We tend to think of this procedure as a transabdominal “vaginal” hysterectomy, since the average diameter of the minilaparotomy opening is approximately the same as the vaginal canal. Further, as in vaginal hysterectomy, only 1 portion of the uterus, adnexa, or ligaments must be exteriorized at a given time. Thus, this approach requires less general exposure but offers effective targeted exposure.

The technique also removes the need for frequent use of traumatic metal retractors, extensive bowel packing, and extended incision exposure. The benefits: diminished postoperative discomfort and bowel dysfunction.

High success rates. We have performed more than 100 minilaparotomy procedures using this technique in patients in whom vaginal hysterectomy was contraindicated. Uterine weight ranged from 80 g to 2,500 g. Mean operating time was 50 minutes. All patients were discharged within 36 hours. Mean return to work time was 12 days, and there have been no intraoperative or postoperative complications. All surgeries were successfully completed without laparoscopy or conversion to traditional laparotomy.

FIGURE 6 Hysterectomy for the large, solid, fibroid uterus

A. Draw the upper uterine attachments to the surgical field with finger traction.

FIGURE 6 Hysterectomy for the large, solid, fibroid uterus

B. Divide the round ligaments and proximal adnexal pedicles, then carry out division of the uterine vessels bilaterally.

FIGURE 6 Hysterectomy for the large, solid, fibroid uterus

C. After dividing both round ligaments, adnexal pedicles, and uterine vessels, place the uterine isthmus in traction with a rubber tourniquet and perform an in situ supracervical amputation.

FIGURE 6 Hysterectomy for the large, solid, fibroid uterus

D. After trachelectomy, the large uterine specimen is removed by morcellation. Notice that the retractor is able to stretch significantly, allowing the exteriorization of uteri with diameters considerably larger than that of the retractor.

Devices that simplify the procedure

Occasionally, hysterectomy using traditional clamp, division, and suture ligation can be tedious, frustrating, and time-consuming, especially when exposure is limited or difficult. Several devices developed for laparoscopic surgery can ease suture ligation and the division of blood vessels, ligaments, and tissue bundles during minilaparotomy hysterectomy. They include the Hem-o-lok ligating clip (Weck Closure Systems); the LigaSure Atlas, a vessel sealer-divider (Valleylab, Tyco Healthcare, Boulder, Colo); the ETS 45-Flex endoscopic linear cutter (Ethicon Endo-Surgery, Cincinnati, Ohio); and the PK bipolar cutting forceps (Gyrus Medical, Maple Grove, Minn).

Additional concerns

Is the incision too large? Fears that incisions over 5 cm might nullify minimally invasive surgery’s benefits have proven unfounded.

Laparoscopic procedures that use a 7-cm to 8-cm incision to introduce the hand into the abdomen, as well as those performed in conjunction with minilaparotomy, have consistently failed to identify a link between these combinations and morbidity or lengthy recovery. A “large” minilaparotomy incision is still superior to a standard abdominal hysterectomy in terms of convalescence, and it is significantly faster and more cost-effective than a prolonged laparoscopic or laparoscopic-assisted vaginal hysterectomy.^3-10

Do any conditions contraindicate minilaparotomy? In patients with documented or strongly suspected severe pelvic conditions (for example, advanced endometriosis, pelvic inflammatory disease, bowel disease, or malignancy), preliminary laparoscopic evaluation to determine the pathologic condition’s severity and extent is strongly recommended.

If during this assessment you detect pathology that is not appropriate for laparoscopic surgery or minilaparotomy, perform a traditional laparotomy. If, however, this evaluation demonstrates that pelvic pathology is amenable to laparoscopic surgery, a laparoscopic hysterectomy or laparoscopic-assisted minilaparotomy hysterectomy is indicated.

Dr. Pelosi II reports that he is a consultant for Apple Medical Corporation. Dr. Pelosi III reports no affiliations or financial arrangements with any of the manufacturers of products mentioned in this article or their competitors.

Although laparoscopic hysterectomy offers a minimally invasive alternative to laparotomy when vaginal hysterectomy is contraindicated, it has its drawbacks. Among them: the cost of expensive equipment, the long learning curve, and prolonged operating time.

We describe another alternative to open surgery that is comparable to laparoscopic hysterectomy in postoperative pain, cosmetic results, and time to return to normal activities. Our procedure—a redesigned minilaparotomy hysterectomy—relies on traditional open techniques and inexpensive novel instrumentation, making it significantly faster than laparoscopy and easy to perform and teach.

For patients who cannot undergo vaginal hysterectomy, this new modality offers an expeditious, minimal-access option. Gynecologists reluctant to relinquish the routine use of standard laparotomy may find this approach an appealing, less-invasive alternative.

Position, incision, and retraction are crucial to success

Our minilaparotomy hysterectomy is a systemized approach with elements derived from both open and laparoscopic surgery. Three preparatory components are involved:

• position
• incision
• retraction

All are critical to a successful hysterectomy, ensuring that the procedure never becomes a haphazard struggle through an improvised, scaled-down, conventional Pfannenstiel or vertical incision. Our approach also avoids cumbersome traditional laparotomy exposure maneuvers and positioning.

Position: Modified lithotomy. After regional or general anesthesia is given, position the patient in a modified lithotomy with both arms tucked as for laparoscopic surgery. Place the legs in boot-type stirrups, with no hip flexion and sufficient thigh abduction to expose the vagina.

Next, perform a thorough pelvic examination and place an indwelling, transurethral catheter. A sturdy, hinged uterine manipulator is of paramount importance for the hysterectomy, as it facilitates exposure of the adnexa as well as elevation/rotation of the uterus and the uterine attachments. We recommend the Pelosi Uterine Manipulator (Apple Medical Corporation, Marlboro, Mass) or its equivalent (FIGURE 1).

Incision: Modified Kustner’s. Open the abdomen with a cruciate incision. Using a conventional scalpel and the Bovie device, make a 2.5-cm to 5-cm transverse incision through the skin and subcutaneous fat until you reach the anterior rectus fascia (FIGURE 2A). Clear the fat from the midline superiorly and inferiorly to expose approximately 5 cm to 6 cm of fascia in the vertical axis. Then incise the anterior rectus fascia in a vertical direction through the full length of the cleared area (FIGURE 2B).

Retract the rectus muscles from the midline, exposing the transversalis fascia and the underlying peritoneum. Enter the peritoneum digitally or with scissors above the level of the bladder dome, incising vertically until the entrance extends the full length of the fascial incision (FIGURE 2C).

This modified Kustner’s incision is essentially a vertical midline incision in its deeper layers.¹ The rapid surgical dissection of the fascia and rectus muscles and the intraperitoneal entry are relatively bloodless. This approach yields a surgical exposure superior to that of a small Pfannenstiel or Maylard incision.

Note that, in some patients, a vertical incision can be selected if there is a prior vertical incision or if the perioperative workup suggests a malignancy that may require a later extension of the original minilaparotomy incision.

Retraction: Soft, sleeve-type, self-retaining abdominal retractor. This device consists of a flexible plastic inner ring and a firmer outer ring connected by a soft plastic sleeve (FIGURE 3A). Two models are available: the Mobius (Apple Medical Corporation) and the Protractor (Weck Closure Systems, Research Triangle Park, NC).

Squeeze the inner ring into the peritoneal cavity through the minilaparotomy incision, allowing it to spring open against the parietal peritoneum. Conduct a digital assessment to ensure that no viscera are trapped by elevating the outer ring. Next, roll the outer ring onto the sleeve, collecting excess length, until it sits firmly against the skin (FIGURES 3B and 3C). The result, when there is adequate tension within the sleeve, is a circular area of retraction offering excellent exposure of the pelvis. Note that during surgery you may need to adjust the outer ring if the sleeve loosens.

The soft, self-retaining abdominal retractor offers several advantages over traditional abdominal retraction:

• Atraumatic retraction. This device distributes retraction force evenly around the entire incision. Because standard retractors concentrate retraction force at only a few points, they often lead to tissue trauma, nerve damage, bruising, and postoperative pain.
• Incision protection. The retractor’s flexible material lines the incision, protecting the wound’s edges from contamination and potential implantation of malignant cells.
• Improved access. Because the continuous retraction force is delivered more effectively to the incision, exposure is maximized. As a result, the need for intensive surgical assistance is dramatically reduced.
• Adjustable height. The retractor’s design lets it adapt to wounds of varying depth—a feature that makes it ideal for obese patients. The device compresses the patient’s skin and peritoneum between the external and internal rings, keeping the full thickness of the abdominal incision constant throughout the surgery.
• Cost-effectiveness. The device, which costs under $100, is simple and fast to set up. In our experience, placement takes approximately 2 minutes; this compares favorably with table-mounted or self-retaining rigid retraction systems, which may require significant capital expenditures (cost may run in the thousands), repair costs, and complicated set-ups.

FIGURE 1 Hinged uterine manipulator

A sturdy hinged uterine manipulator facilitates exposure of the adnexa as well as elevation/rotation of the uterus.

FIGURE 2 Cruciate incision

A. Make a transverse incision suprapubically through the skin and the subcutaneous fat to reach the anterior rectus fascia.

FIGURE 2 Cruciate incision

B. Clear the fat from the midline to expose the rectus fascia in the vertical axis, then incise the fascia in a vertical direction through the full length of the previously cleared area. The rectus muscles are retracted, thereby exposing the peritoneum.

FIGURE 2 Cruciate incision

C. Incise the peritoneum vertically until it extends the full length of the fascial incision.

FIGURE 3 Soft, sleeve-type, self-retaining abdominal retractor

A. At left, the Protractor (Weck Closure Systems); at right, the Mobius (Apple Medical Corporation).

FIGURE 3 Soft, sleeve-type, self-retaining abdominal retractor

B. After inserting the inner ring into the peritoneal cavity, twist the outer ring downward until it inverts and rests snuggly against the skin.

FIGURE 3 Soft, sleeve-type, self-retaining abdominal retractor

C. An atraumatic, circular, self-retaining area of retraction is created.

Standard technique: Exteriorize the uterus; divide uterine attachments, vessels

Assess the anatomy. Using your index finger and the uterine manipulator to rotate and flex the uterus, carefully assess the uterus, adnexa, and pelvis, noting the location of the ureters. Determine the extent of any unexpected pelvic pathology or adhesions, using traditional small retractors or gentle packing to gain additional exposure. Perform any adhesiolysis that is necessary.

Exteriorize the uterus. Next, bring the uterus and the adnexa above the abdominal wall in order to perform as much of the hysterectomy extracorporeally as possible. Pass the uterus or adnexa through the incision with the upward assistance of the uterine manipulator, then divide the upper uterine attachments (FIGURE 4A).

Increase exposure. You can achieve additional uterine elevation and targeted exposure in several ways. For example, a strong traction suture can be placed in the uterine fundus, left long, and secured with a clamp. To achieve uterine elevation, place long clamps lateral to the corpus. Another effective approach is to place a heavy tenaculum on the uterine fundus.

When lateral exposure is limited, divide the proximal adnexal pedicles and round ligaments to begin the operation, and remove the adnexa separately following the completion of the hysterectomy.

Divide the uterine vessels through the small incision using clamping, division, and ligation. Unless you intend to preserve the cervix, mobilize the bladder to the level of the anterior vaginal fornix. Inward pressure on the uterine manipulator provides additional elevation of the lower uterine vasculature and the cardinal and uterosacral ligaments as these structures are ligated and divided. Amputate the uterine specimen from the vaginal cuff using the uterine manipulator to guide the vaginal circumcision (FIGURE 4B). Close the vaginal cuff using standard closure.

If the cervix is to be preserved, amputate the uterus supracervically following division of the uterine vessels. Then suture the cervical stump in the traditional fashion. Upward elevation of the cervix using the uterine manipulator expedites this step.

Complete the procedure. Once the surgery is completed, remove the retractor, hooking the bottom ring by inserting a finger into it and pulling it up and out of the incision (FIGURE 4C). Closing a cruciate incision is faster and requires less exposure than closing a mini-Pfannenstiel incision. Eliminate the possibility of postoperative wound hematoma or seroma formation by applying a vertical pressure dressing over the incision (FIGURE 4D). Remove the dressing 24 hours later.

FIGURE 4 Hysterectomy for the normal to moderately enlarged uterus

A. Exteriorize the uterus as much as possible with both upward assistance of the manipulator and uterine fundal elevation (using clamps lateral to the uterus, a heavy tenaculum, or a traction suture). Then conduct a standard hysterectomy.

FIGURE 4 Hysterectomy for the normal to moderately enlarged uterus

B. Separate the uterus from the vagina using the manipulator to guide the vaginal circumcision. (If the cervix is to be preserved, a supracervical amputation is performed instead.)

FIGURE 4 Hysterectomy for the normal to moderately enlarged uterus

C. After completing the surgery, remove the retractor from the incision.

FIGURE 4 Hysterectomy for the normal to moderately enlarged uterus

D. Apply a vertical pressure dressing over the incision.

Variations for abnormal uteri

The large fibroid uterus: Begin with the dominant myoma. A large fibroid uterus can be easily removed with our minilaparotomy technique using 3 basic steps:

1. Reduce size by selective myomectomy.
2. Deliver the debulked uterus through the abdominal incision.
3. Perform extracorporeal hysterectomy.

First, you must conduct a thorough assessment of the number, size, and location of the myomas. Begin the myomectomy on the largest tumor of those closest to the minilaparotomy incision. (Minimize bleeding by injecting diluted vasopressin subserosally prior to the procedure.)

Incise the uterine serosa, myometrium, and pseudocapsule of the myoma via scalpel or Bovie electrocautery until the whorly appearance of the myoma is apparent. Next, grasp the myoma with claw-toothed forceps to stabilize it and place it under traction. Then, using a combination of sharp and digital dissection, develop a plane of dissection between the fibroid and the myometrium (FIGURE 5A).

After securing the dominant myoma, deliver it through the abdominal incision. If the myoma is too large to be removed intact from the abdominal cavity, morcellate it using a scalpel or scissors (FIGURE 5B). Then continue systematic removal of the remaining myomas using the same approach. It is not necessary to remove all myomas—the goal of this process is merely to permit delivery of the uterine body for subsequent hysterectomy.

Once the uterus is debulked, deliver it through the abdominal incision. Hysterectomy then is easily completed (FIGURE 5C).

The ‘solid’ uterus: In situ supracervical hysterectomy and uterine morcellation.

Very large uteri are sometimes homogeneous and solid in nature, possessing few or no individual myomas. This so-called cannonball fibroid uterus is the most challenging type of uterus to remove. The selective-myomectomy approach cannot be used because of the potential for massive bleeding and the technical anatomical difficulties that arise when operating through such a small abdominal incision.

Instead, manage this type of uterus by performing a deliberate in situ supracervical hysterectomy through the minilaparotomy incision. At the end of this procedure, morcellate the amputated fibroid uterus.

Begin the surgery by dividing the upper uterine attachments. Regardless of uterine size, the origins of the round and adnexal ligaments will always be lateral to and within easy reach of a transverse minilaparotomy incision. (Access to these areas is the only factor that determines the feasibility of this procedure; uterine size is completely irrelevant.) We have found that these elongated ligaments are quite lax. Thus, in most cases it is relatively simple to navigate your index finger laterally and, using digital traction, elevate these structures into the minilaparotomy incision (FIGURE 6A). You can then clamp, cut, and suture the ligaments in the standard fashion in whatever sequence is most efficient.

Thanks to the retractor, minimal assistance is necessary during the surgery. You can create additional exposure by deflecting the uterus toward the opposite side of the pelvis using external abdominal pressure and the uterine manipulator.

Once both round ligaments and adnexal pedicles are divided, dissect the bladder flap to expose the uterine arteries (inward pressure on the uterine manipulator provides helpful countertraction). Then clamp, divide, and ligate the uterine arteries (FIGURE 6B).

The uterus is now ready for supracervical amputation. Upward traction on the isthmus by means of a rubber tourniquet facilitates uterine division (FIGURE 6C). After the uterus is amputated, push it toward the upper abdomen to increase exposure for suturing of the cervical stump (if the cervix is preserved) or for cervical excision and vaginal cuff closure (when total hysterectomy is chosen).

Next, remove the uterine specimen by morcellation through the minilaparotomy incision. Using the Doyen ladder-shaped uterine morcellation technique (originally described in the early 1920s) grasp an area of the uterus and, alternating right and left, make deep but incomplete incisions on the uterus, creating a ladder shape.² Because of its elasticity, the retractor can stretch quite significantly without tearing the edges of the abdominal incision (FIGURE 6D). This allows the easy exteriorization of uteri with diameters considerably larger than that of the retractor, mimicking the stretching of the perineum during the crowning of the fetal head.

When the surgery is complete, remove the retractor, close the minilaparotomy incision, and apply a vertical pressure dressing over the incision. Neither vaginal packing nor bladder catheterization is required.

FIGURE 5 Hysterectomy for the fibroid uterus

A. Develop a plane of dissection between the myoma and myometrium.

FIGURE 5 Hysterectomy for the fibroid uterus

B. Deliver the myoma through the incision; if it is too large to remove intact, morcellate it with a scalpel or scissors.

FIGURE 5 Hysterectomy for the fibroid uterus

C. After reducing the uterine size by selective myomectomy, deliver the debulked uterus through the abdominal incision. Then proceed with an extracorporeal total or subtotal hysterectomy.

A short learning curve

Since it uses conventional open techniques and traditional instrumentation, this method can be learned and mastered quickly.

We tend to think of this procedure as a transabdominal “vaginal” hysterectomy, since the average diameter of the minilaparotomy opening is approximately the same as the vaginal canal. Further, as in vaginal hysterectomy, only 1 portion of the uterus, adnexa, or ligaments must be exteriorized at a given time. Thus, this approach requires less general exposure but offers effective targeted exposure.

The technique also removes the need for frequent use of traumatic metal retractors, extensive bowel packing, and extended incision exposure. The benefits: diminished postoperative discomfort and bowel dysfunction.

High success rates. We have performed more than 100 minilaparotomy procedures using this technique in patients in whom vaginal hysterectomy was contraindicated. Uterine weight ranged from 80 g to 2,500 g. Mean operating time was 50 minutes. All patients were discharged within 36 hours. Mean return to work time was 12 days, and there have been no intraoperative or postoperative complications. All surgeries were successfully completed without laparoscopy or conversion to traditional laparotomy.

FIGURE 6 Hysterectomy for the large, solid, fibroid uterus

A. Draw the upper uterine attachments to the surgical field with finger traction.

FIGURE 6 Hysterectomy for the large, solid, fibroid uterus

B. Divide the round ligaments and proximal adnexal pedicles, then carry out division of the uterine vessels bilaterally.

FIGURE 6 Hysterectomy for the large, solid, fibroid uterus

C. After dividing both round ligaments, adnexal pedicles, and uterine vessels, place the uterine isthmus in traction with a rubber tourniquet and perform an in situ supracervical amputation.

FIGURE 6 Hysterectomy for the large, solid, fibroid uterus

D. After trachelectomy, the large uterine specimen is removed by morcellation. Notice that the retractor is able to stretch significantly, allowing the exteriorization of uteri with diameters considerably larger than that of the retractor.

Devices that simplify the procedure

Occasionally, hysterectomy using traditional clamp, division, and suture ligation can be tedious, frustrating, and time-consuming, especially when exposure is limited or difficult. Several devices developed for laparoscopic surgery can ease suture ligation and the division of blood vessels, ligaments, and tissue bundles during minilaparotomy hysterectomy. They include the Hem-o-lok ligating clip (Weck Closure Systems); the LigaSure Atlas, a vessel sealer-divider (Valleylab, Tyco Healthcare, Boulder, Colo); the ETS 45-Flex endoscopic linear cutter (Ethicon Endo-Surgery, Cincinnati, Ohio); and the PK bipolar cutting forceps (Gyrus Medical, Maple Grove, Minn).

Additional concerns

Is the incision too large? Fears that incisions over 5 cm might nullify minimally invasive surgery’s benefits have proven unfounded.

Laparoscopic procedures that use a 7-cm to 8-cm incision to introduce the hand into the abdomen, as well as those performed in conjunction with minilaparotomy, have consistently failed to identify a link between these combinations and morbidity or lengthy recovery. A “large” minilaparotomy incision is still superior to a standard abdominal hysterectomy in terms of convalescence, and it is significantly faster and more cost-effective than a prolonged laparoscopic or laparoscopic-assisted vaginal hysterectomy.^3-10

Do any conditions contraindicate minilaparotomy? In patients with documented or strongly suspected severe pelvic conditions (for example, advanced endometriosis, pelvic inflammatory disease, bowel disease, or malignancy), preliminary laparoscopic evaluation to determine the pathologic condition’s severity and extent is strongly recommended.

If during this assessment you detect pathology that is not appropriate for laparoscopic surgery or minilaparotomy, perform a traditional laparotomy. If, however, this evaluation demonstrates that pelvic pathology is amenable to laparoscopic surgery, a laparoscopic hysterectomy or laparoscopic-assisted minilaparotomy hysterectomy is indicated.

Dr. Pelosi II reports that he is a consultant for Apple Medical Corporation. Dr. Pelosi III reports no affiliations or financial arrangements with any of the manufacturers of products mentioned in this article or their competitors.

Although laparoscopic hysterectomy offers a minimally invasive alternative to laparotomy when vaginal hysterectomy is contraindicated, it has its drawbacks. Among them: the cost of expensive equipment, the long learning curve, and prolonged operating time.

We describe another alternative to open surgery that is comparable to laparoscopic hysterectomy in postoperative pain, cosmetic results, and time to return to normal activities. Our procedure—a redesigned minilaparotomy hysterectomy—relies on traditional open techniques and inexpensive novel instrumentation, making it significantly faster than laparoscopy and easy to perform and teach.

For patients who cannot undergo vaginal hysterectomy, this new modality offers an expeditious, minimal-access option. Gynecologists reluctant to relinquish the routine use of standard laparotomy may find this approach an appealing, less-invasive alternative.

Position, incision, and retraction are crucial to success

Our minilaparotomy hysterectomy is a systemized approach with elements derived from both open and laparoscopic surgery. Three preparatory components are involved:

• position
• incision
• retraction

All are critical to a successful hysterectomy, ensuring that the procedure never becomes a haphazard struggle through an improvised, scaled-down, conventional Pfannenstiel or vertical incision. Our approach also avoids cumbersome traditional laparotomy exposure maneuvers and positioning.

Position: Modified lithotomy. After regional or general anesthesia is given, position the patient in a modified lithotomy with both arms tucked as for laparoscopic surgery. Place the legs in boot-type stirrups, with no hip flexion and sufficient thigh abduction to expose the vagina.

Next, perform a thorough pelvic examination and place an indwelling, transurethral catheter. A sturdy, hinged uterine manipulator is of paramount importance for the hysterectomy, as it facilitates exposure of the adnexa as well as elevation/rotation of the uterus and the uterine attachments. We recommend the Pelosi Uterine Manipulator (Apple Medical Corporation, Marlboro, Mass) or its equivalent (FIGURE 1).