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Is long-term outcome with TVT comparable to that of laparoscopic Burch colposuspension?

SPOTLIGHT ON URINARY INCONTINENCE

Just 2 years ago, when Brubaker and colleagues published initial findings from the colpopexy and urinary reduction efforts (CARE) trial in the New England Journal of Medicine,1 Burch colposuspension was a well-established anti-incontinence procedure utilized by many urogynecologists. The procedure remains a reliable intervention, although midurethral sling procedures have surpassed it in popularity and (some would say) efficacy. This issue’s installment of Examining the Evidence highlights two recent investigations of the antiincontinence procedure:

  • 2-year follow-up from the CARE trial, which compared sacrocolpopexy, with and without a concomitant Burch procedure, in women who did not have symptoms of stress urinary incontinence (SUI) at the time of surgery
  • a comparison of laparoscopic Burch colposuspension and the tension-free vaginal tape (TVT) technique.
Since introduction of the TVT technique by Ulmsten and colleagues in 1996, midurethral tension-free sling procedures have become the most commonly performed antiincontinence operations in the world, rapidly replacing Burch colposuspension as the first choice for women who have urodynamically confirmed SUI.1 In 2004, a prospective, randomized trial by Ward and Hilton demonstrated that the TVT was equal and perhaps even superior to the Burch procedure.2 The same year, Paraiso and associates reported on a two-center prospective randomized trial of laparoscopic Burch colposuspension versus TVT.3 Although that trial was underpowered, the investigators found a higher rate of objective urodynamic SUI and subjective urinary incontinence 1 year after laparoscopic Burch colposuspension, compared with TVT.3 The study by Jelovsek and colleagues represents the long-term follow-up of this cohort, 4 to 8 years after the original operation.

Details of the study

Seventy-two women were originally enrolled from 1999 to 2002; 74% of them (25 in the TVT group and 28 in the laparoscopic Burch group) were available for long-term followup 4 to 8 years after surgery. Fifty-seven percent (16/28) of women had subjective urinary incontinence after laparoscopic Burch colposuspension versus 48% (12/25) after TVT. There were no differences between the groups in subjective or objective findings or urinary incontinence. However, the study was severely underpowered to be able to show any difference between the groups.

These cure rates are low, but the authors note that only 11% of the laparoscopic Burch group and 8% of the TVT group had bothersome SUI. Quality of life on the urogenital distress inventory and incontinence impact questionnaire short forms was improved in both groups equally by 2 years and maintained throughout the rest of the trial.

These poor objective results are similar to those found in a 5-year follow-up by Ward and Hilton of their prospective, randomized, controlled trial of Burch versus TVT procedures. There, only 39% of the TVT group and 46% of the Burch group reported no incontinence.

The original trial by Paraiso and colleagues3 showed better outcomes in the TVT group 1 year after surgery, but that difference did not remain 4 to 8 years later. One explanation for that observation may be type-II error resulting from the small number of subjects in the trial.

WHAT THIS EVIDENCE MEANS FOR PRACTICE

Laparoscopic Burch colposuspension and the TVT procedure appear to have equal long-term outcomes. Because placing TVT is less invasive, however, it may be the preferable procedure until larger trials or meta-analyses conclusively determine which operation is superior.—PETER K. SAND, MD

References

1. Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1996;7:81-86.

2. Ward KL, Hilton P. On behalf of the UK and Ireland TVT Trial Group. A prospective multicenter randomized trial of tension-free vaginal tape and colposuspension for primary urodynamic stress incontinence: two-year follow-up. Am J Obstet Gynecol. 2004;190:324-331.

3. Paraiso MF, Walters MD, Karram MM, Barber MD. Laparoscopic Burch colposuspension versus tension-free vaginal tape: a randomized trial. Obstet Gynecol. 2004;104:1249-1258.

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Yes This randomized trial found similar long-term efficacy for TVT and laparoscopic Burch colposuspension for the treatment of urodynamically confirmed SUI. Four to 8 years after surgery, a substantial percentage of women in both arms of the trial had some degree of incontinence. However, incontinence was “bothersome” in only 11% of women undergoing the Burch procedure versus 8% of women treated with TVT—a difference that was statistically insignificant.

Jelovsek JE, Barber MD, Karram MM, Walters MD, Paraiso MFR. Randomised trial of laparoscopic Burch colposuspension versus tension-free vaginal tape: long-term follow-up. BJOG. 2008;115:219–225.

EXPERT COMMENTARY

Peter K. Sand, MD
Professor of Obstetrics and Gynecology and Gynecologic Surgery, Feinberg School of Medicine, Northwestern University, Chicago.

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Peter K. Sand MD; Examining the Evidence; Burch colposuspension; colposuspension; transvaginal mesh; urinary incontinence; stress urinary incontinence; SUI; TVT; tension-free transvaginal tape; Food and Drug Administration; FDA; FDA alert; surgical mesh; pain; urinary problems; erosion; prolapse; incontinence; vaginal scarring; bowel perforation; bladder perforation; complications; infection; mesh placement; tension-free vaginal tape
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Yes This randomized trial found similar long-term efficacy for TVT and laparoscopic Burch colposuspension for the treatment of urodynamically confirmed SUI. Four to 8 years after surgery, a substantial percentage of women in both arms of the trial had some degree of incontinence. However, incontinence was “bothersome” in only 11% of women undergoing the Burch procedure versus 8% of women treated with TVT—a difference that was statistically insignificant.

Jelovsek JE, Barber MD, Karram MM, Walters MD, Paraiso MFR. Randomised trial of laparoscopic Burch colposuspension versus tension-free vaginal tape: long-term follow-up. BJOG. 2008;115:219–225.

EXPERT COMMENTARY

Peter K. Sand, MD
Professor of Obstetrics and Gynecology and Gynecologic Surgery, Feinberg School of Medicine, Northwestern University, Chicago.

Author and Disclosure Information

Yes This randomized trial found similar long-term efficacy for TVT and laparoscopic Burch colposuspension for the treatment of urodynamically confirmed SUI. Four to 8 years after surgery, a substantial percentage of women in both arms of the trial had some degree of incontinence. However, incontinence was “bothersome” in only 11% of women undergoing the Burch procedure versus 8% of women treated with TVT—a difference that was statistically insignificant.

Jelovsek JE, Barber MD, Karram MM, Walters MD, Paraiso MFR. Randomised trial of laparoscopic Burch colposuspension versus tension-free vaginal tape: long-term follow-up. BJOG. 2008;115:219–225.

EXPERT COMMENTARY

Peter K. Sand, MD
Professor of Obstetrics and Gynecology and Gynecologic Surgery, Feinberg School of Medicine, Northwestern University, Chicago.

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SPOTLIGHT ON URINARY INCONTINENCE

Just 2 years ago, when Brubaker and colleagues published initial findings from the colpopexy and urinary reduction efforts (CARE) trial in the New England Journal of Medicine,1 Burch colposuspension was a well-established anti-incontinence procedure utilized by many urogynecologists. The procedure remains a reliable intervention, although midurethral sling procedures have surpassed it in popularity and (some would say) efficacy. This issue’s installment of Examining the Evidence highlights two recent investigations of the antiincontinence procedure:

  • 2-year follow-up from the CARE trial, which compared sacrocolpopexy, with and without a concomitant Burch procedure, in women who did not have symptoms of stress urinary incontinence (SUI) at the time of surgery
  • a comparison of laparoscopic Burch colposuspension and the tension-free vaginal tape (TVT) technique.
Since introduction of the TVT technique by Ulmsten and colleagues in 1996, midurethral tension-free sling procedures have become the most commonly performed antiincontinence operations in the world, rapidly replacing Burch colposuspension as the first choice for women who have urodynamically confirmed SUI.1 In 2004, a prospective, randomized trial by Ward and Hilton demonstrated that the TVT was equal and perhaps even superior to the Burch procedure.2 The same year, Paraiso and associates reported on a two-center prospective randomized trial of laparoscopic Burch colposuspension versus TVT.3 Although that trial was underpowered, the investigators found a higher rate of objective urodynamic SUI and subjective urinary incontinence 1 year after laparoscopic Burch colposuspension, compared with TVT.3 The study by Jelovsek and colleagues represents the long-term follow-up of this cohort, 4 to 8 years after the original operation.

Details of the study

Seventy-two women were originally enrolled from 1999 to 2002; 74% of them (25 in the TVT group and 28 in the laparoscopic Burch group) were available for long-term followup 4 to 8 years after surgery. Fifty-seven percent (16/28) of women had subjective urinary incontinence after laparoscopic Burch colposuspension versus 48% (12/25) after TVT. There were no differences between the groups in subjective or objective findings or urinary incontinence. However, the study was severely underpowered to be able to show any difference between the groups.

These cure rates are low, but the authors note that only 11% of the laparoscopic Burch group and 8% of the TVT group had bothersome SUI. Quality of life on the urogenital distress inventory and incontinence impact questionnaire short forms was improved in both groups equally by 2 years and maintained throughout the rest of the trial.

These poor objective results are similar to those found in a 5-year follow-up by Ward and Hilton of their prospective, randomized, controlled trial of Burch versus TVT procedures. There, only 39% of the TVT group and 46% of the Burch group reported no incontinence.

The original trial by Paraiso and colleagues3 showed better outcomes in the TVT group 1 year after surgery, but that difference did not remain 4 to 8 years later. One explanation for that observation may be type-II error resulting from the small number of subjects in the trial.

WHAT THIS EVIDENCE MEANS FOR PRACTICE

Laparoscopic Burch colposuspension and the TVT procedure appear to have equal long-term outcomes. Because placing TVT is less invasive, however, it may be the preferable procedure until larger trials or meta-analyses conclusively determine which operation is superior.—PETER K. SAND, MD

SPOTLIGHT ON URINARY INCONTINENCE

Just 2 years ago, when Brubaker and colleagues published initial findings from the colpopexy and urinary reduction efforts (CARE) trial in the New England Journal of Medicine,1 Burch colposuspension was a well-established anti-incontinence procedure utilized by many urogynecologists. The procedure remains a reliable intervention, although midurethral sling procedures have surpassed it in popularity and (some would say) efficacy. This issue’s installment of Examining the Evidence highlights two recent investigations of the antiincontinence procedure:

  • 2-year follow-up from the CARE trial, which compared sacrocolpopexy, with and without a concomitant Burch procedure, in women who did not have symptoms of stress urinary incontinence (SUI) at the time of surgery
  • a comparison of laparoscopic Burch colposuspension and the tension-free vaginal tape (TVT) technique.
Since introduction of the TVT technique by Ulmsten and colleagues in 1996, midurethral tension-free sling procedures have become the most commonly performed antiincontinence operations in the world, rapidly replacing Burch colposuspension as the first choice for women who have urodynamically confirmed SUI.1 In 2004, a prospective, randomized trial by Ward and Hilton demonstrated that the TVT was equal and perhaps even superior to the Burch procedure.2 The same year, Paraiso and associates reported on a two-center prospective randomized trial of laparoscopic Burch colposuspension versus TVT.3 Although that trial was underpowered, the investigators found a higher rate of objective urodynamic SUI and subjective urinary incontinence 1 year after laparoscopic Burch colposuspension, compared with TVT.3 The study by Jelovsek and colleagues represents the long-term follow-up of this cohort, 4 to 8 years after the original operation.

Details of the study

Seventy-two women were originally enrolled from 1999 to 2002; 74% of them (25 in the TVT group and 28 in the laparoscopic Burch group) were available for long-term followup 4 to 8 years after surgery. Fifty-seven percent (16/28) of women had subjective urinary incontinence after laparoscopic Burch colposuspension versus 48% (12/25) after TVT. There were no differences between the groups in subjective or objective findings or urinary incontinence. However, the study was severely underpowered to be able to show any difference between the groups.

These cure rates are low, but the authors note that only 11% of the laparoscopic Burch group and 8% of the TVT group had bothersome SUI. Quality of life on the urogenital distress inventory and incontinence impact questionnaire short forms was improved in both groups equally by 2 years and maintained throughout the rest of the trial.

These poor objective results are similar to those found in a 5-year follow-up by Ward and Hilton of their prospective, randomized, controlled trial of Burch versus TVT procedures. There, only 39% of the TVT group and 46% of the Burch group reported no incontinence.

The original trial by Paraiso and colleagues3 showed better outcomes in the TVT group 1 year after surgery, but that difference did not remain 4 to 8 years later. One explanation for that observation may be type-II error resulting from the small number of subjects in the trial.

WHAT THIS EVIDENCE MEANS FOR PRACTICE

Laparoscopic Burch colposuspension and the TVT procedure appear to have equal long-term outcomes. Because placing TVT is less invasive, however, it may be the preferable procedure until larger trials or meta-analyses conclusively determine which operation is superior.—PETER K. SAND, MD

References

1. Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1996;7:81-86.

2. Ward KL, Hilton P. On behalf of the UK and Ireland TVT Trial Group. A prospective multicenter randomized trial of tension-free vaginal tape and colposuspension for primary urodynamic stress incontinence: two-year follow-up. Am J Obstet Gynecol. 2004;190:324-331.

3. Paraiso MF, Walters MD, Karram MM, Barber MD. Laparoscopic Burch colposuspension versus tension-free vaginal tape: a randomized trial. Obstet Gynecol. 2004;104:1249-1258.

References

1. Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1996;7:81-86.

2. Ward KL, Hilton P. On behalf of the UK and Ireland TVT Trial Group. A prospective multicenter randomized trial of tension-free vaginal tape and colposuspension for primary urodynamic stress incontinence: two-year follow-up. Am J Obstet Gynecol. 2004;190:324-331.

3. Paraiso MF, Walters MD, Karram MM, Barber MD. Laparoscopic Burch colposuspension versus tension-free vaginal tape: a randomized trial. Obstet Gynecol. 2004;104:1249-1258.

Issue
OBG Management - 20(12)
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OBG Management - 20(12)
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20-24
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Is long-term outcome with TVT comparable to that of laparoscopic Burch colposuspension?
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Is long-term outcome with TVT comparable to that of laparoscopic Burch colposuspension?
Legacy Keywords
Peter K. Sand MD; Examining the Evidence; Burch colposuspension; colposuspension; transvaginal mesh; urinary incontinence; stress urinary incontinence; SUI; TVT; tension-free transvaginal tape; Food and Drug Administration; FDA; FDA alert; surgical mesh; pain; urinary problems; erosion; prolapse; incontinence; vaginal scarring; bowel perforation; bladder perforation; complications; infection; mesh placement; tension-free vaginal tape
Legacy Keywords
Peter K. Sand MD; Examining the Evidence; Burch colposuspension; colposuspension; transvaginal mesh; urinary incontinence; stress urinary incontinence; SUI; TVT; tension-free transvaginal tape; Food and Drug Administration; FDA; FDA alert; surgical mesh; pain; urinary problems; erosion; prolapse; incontinence; vaginal scarring; bowel perforation; bladder perforation; complications; infection; mesh placement; tension-free vaginal tape
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