Gynecology

Voiding trials after female pelvic floor surgery may detect similar rates of voiding dysfunction regardless of whether voiding occurs spontaneously or after the bladder is retrograde-filled with saline, according to a randomized study.

Nevertheless, patients may prefer the more common retrograde-fill approach.

In the study of 109 patients, those who underwent retrograde fill reported significantly greater satisfaction with their method of voiding evaluation, compared with patients whose voiding trials occurred spontaneously. The increased satisfaction could relate to the fact that retrograde-fill trials take less time, study investigator Patrick Popiel, MD, of Yale University, New Haven, Conn., suggested at the virtual annual scientific meeting of the Society of Gynecologic Surgeons. The exact reasons are unclear, however.

Voiding trials help identify patients who cannot sufficiently empty their bladder after surgery. Prior research has indicated that the incidence of voiding dysfunction after pelvic floor surgery is about 25%-35%. “Patients with voiding dysfunction are generally managed with an indwelling Foley catheter or clean intermittent self-catheterization,” Dr. Popiel said. “Catheterization increases the risk of urinary tract infection, increases anxiety, and decreases patient satisfaction. A large proportion of patients who are discharged home with a Foley catheter state that the catheter was the worst aspect of their experience.”

Dr. Popiel and colleagues conducted a randomized, prospective study to examine the rate of failed voiding trials that necessitate discharge home with an indwelling Foley catheter using spontaneous and retrograde-fill approaches. The study included women who required a voiding trial after surgery for pelvic organ prolapse or urinary incontinence. Patients who required prolonged catheterization after surgery, such as those with a urinary tract infection, bowel injury, or large amount of blood loss, were excluded.

Researchers analyzed data from 55 patients who were randomly assigned to the retrograde-fill group and 54 patients who were randomly assigned to the spontaneous trial group.

In the spontaneous group, patients were required to void at least 150 mL at one time within 6 hours of catheter removal to successfully complete the voiding trial.

In the retrograde-fill group, the bladder was filled in the postanesthesia care unit with 300 mL of saline or until the maximum volume tolerated by the patient (not exceeding 300 mL ) was reached. Patients in this group had to void at least 150 mL or 50% of the instilled volume at one time within 60 minutes of catheter removal to pass the trial.

The researchers documented postvoid residual (PVR) but did not use this measure to determine voiding function.

The baseline demographics of the two groups were similar, although prior hysterectomy was more common in the retrograde-fill group than in the spontaneous group (32.7% vs. 14.8%). The average age was 58.5 years in the retrograde-fill group and 61 years in the spontaneous group.

“There was no significant difference in our primary outcome,” Dr. Popiel said. “There was a 12.7% rate of failed voiding trial in the retrograde group versus 7.7% in the spontaneous group.”

No patients had urinary retention after initially passing their voiding trial. Force of stream did not differ between groups, and about 15% in each group had a postoperative urinary tract infection.

The study demonstrates that voiding assessment based on a spontaneous minimum void of 150 mL is safe and has similar pass rates, compared with the more commonly performed retrograde void trial, Dr. Popiel said. “If the voided amount is at least 150 mL, PVR is not critical to obtain. The study adds to the body of literature that supports less stringent criteria for evaluating voiding function and can limit postoperative urinary recatheterization.”

The investigators allowed patients with PVRs as high as 575 mL to return home without an alternative way to empty the bladder, C. Sage Claydon, MD, a urogynecologist who was not involved in the study, noted during a discussion after the presentation. In all, 6 patients who met the passing criteria for the spontaneous voiding trial had a PVR greater than 200 mL, with volumes ranging from 205-575 mL.

The patients received standardized counseling about postoperative voiding problems, said Dr. Popiel. “This is similar to the work done by Ingber et al. from 2011, where patients who reached a certain force of stream, greater than 5 out of 10, were discharged home regardless of PVR.”

Dr. Popiel had no relevant disclosures. Two coinvestigators disclosed ties to BlossomMed, Renovia, and ArmadaHealth.

[email protected]

SOURCE: Popiel P et al. SGS 2020, Abstract 14.

Voiding trials after female pelvic floor surgery may detect similar rates of voiding dysfunction regardless of whether voiding occurs spontaneously or after the bladder is retrograde-filled with saline, according to a randomized study.

Nevertheless, patients may prefer the more common retrograde-fill approach.

In the study of 109 patients, those who underwent retrograde fill reported significantly greater satisfaction with their method of voiding evaluation, compared with patients whose voiding trials occurred spontaneously. The increased satisfaction could relate to the fact that retrograde-fill trials take less time, study investigator Patrick Popiel, MD, of Yale University, New Haven, Conn., suggested at the virtual annual scientific meeting of the Society of Gynecologic Surgeons. The exact reasons are unclear, however.

Voiding trials help identify patients who cannot sufficiently empty their bladder after surgery. Prior research has indicated that the incidence of voiding dysfunction after pelvic floor surgery is about 25%-35%. “Patients with voiding dysfunction are generally managed with an indwelling Foley catheter or clean intermittent self-catheterization,” Dr. Popiel said. “Catheterization increases the risk of urinary tract infection, increases anxiety, and decreases patient satisfaction. A large proportion of patients who are discharged home with a Foley catheter state that the catheter was the worst aspect of their experience.”

Dr. Popiel and colleagues conducted a randomized, prospective study to examine the rate of failed voiding trials that necessitate discharge home with an indwelling Foley catheter using spontaneous and retrograde-fill approaches. The study included women who required a voiding trial after surgery for pelvic organ prolapse or urinary incontinence. Patients who required prolonged catheterization after surgery, such as those with a urinary tract infection, bowel injury, or large amount of blood loss, were excluded.

Researchers analyzed data from 55 patients who were randomly assigned to the retrograde-fill group and 54 patients who were randomly assigned to the spontaneous trial group.

In the spontaneous group, patients were required to void at least 150 mL at one time within 6 hours of catheter removal to successfully complete the voiding trial.

In the retrograde-fill group, the bladder was filled in the postanesthesia care unit with 300 mL of saline or until the maximum volume tolerated by the patient (not exceeding 300 mL ) was reached. Patients in this group had to void at least 150 mL or 50% of the instilled volume at one time within 60 minutes of catheter removal to pass the trial.

The researchers documented postvoid residual (PVR) but did not use this measure to determine voiding function.

The baseline demographics of the two groups were similar, although prior hysterectomy was more common in the retrograde-fill group than in the spontaneous group (32.7% vs. 14.8%). The average age was 58.5 years in the retrograde-fill group and 61 years in the spontaneous group.

“There was no significant difference in our primary outcome,” Dr. Popiel said. “There was a 12.7% rate of failed voiding trial in the retrograde group versus 7.7% in the spontaneous group.”

No patients had urinary retention after initially passing their voiding trial. Force of stream did not differ between groups, and about 15% in each group had a postoperative urinary tract infection.

The study demonstrates that voiding assessment based on a spontaneous minimum void of 150 mL is safe and has similar pass rates, compared with the more commonly performed retrograde void trial, Dr. Popiel said. “If the voided amount is at least 150 mL, PVR is not critical to obtain. The study adds to the body of literature that supports less stringent criteria for evaluating voiding function and can limit postoperative urinary recatheterization.”

The investigators allowed patients with PVRs as high as 575 mL to return home without an alternative way to empty the bladder, C. Sage Claydon, MD, a urogynecologist who was not involved in the study, noted during a discussion after the presentation. In all, 6 patients who met the passing criteria for the spontaneous voiding trial had a PVR greater than 200 mL, with volumes ranging from 205-575 mL.

The patients received standardized counseling about postoperative voiding problems, said Dr. Popiel. “This is similar to the work done by Ingber et al. from 2011, where patients who reached a certain force of stream, greater than 5 out of 10, were discharged home regardless of PVR.”

Dr. Popiel had no relevant disclosures. Two coinvestigators disclosed ties to BlossomMed, Renovia, and ArmadaHealth.

[email protected]

SOURCE: Popiel P et al. SGS 2020, Abstract 14.

Voiding trials after female pelvic floor surgery may detect similar rates of voiding dysfunction regardless of whether voiding occurs spontaneously or after the bladder is retrograde-filled with saline, according to a randomized study.

Nevertheless, patients may prefer the more common retrograde-fill approach.

In the study of 109 patients, those who underwent retrograde fill reported significantly greater satisfaction with their method of voiding evaluation, compared with patients whose voiding trials occurred spontaneously. The increased satisfaction could relate to the fact that retrograde-fill trials take less time, study investigator Patrick Popiel, MD, of Yale University, New Haven, Conn., suggested at the virtual annual scientific meeting of the Society of Gynecologic Surgeons. The exact reasons are unclear, however.

Voiding trials help identify patients who cannot sufficiently empty their bladder after surgery. Prior research has indicated that the incidence of voiding dysfunction after pelvic floor surgery is about 25%-35%. “Patients with voiding dysfunction are generally managed with an indwelling Foley catheter or clean intermittent self-catheterization,” Dr. Popiel said. “Catheterization increases the risk of urinary tract infection, increases anxiety, and decreases patient satisfaction. A large proportion of patients who are discharged home with a Foley catheter state that the catheter was the worst aspect of their experience.”

Dr. Popiel and colleagues conducted a randomized, prospective study to examine the rate of failed voiding trials that necessitate discharge home with an indwelling Foley catheter using spontaneous and retrograde-fill approaches. The study included women who required a voiding trial after surgery for pelvic organ prolapse or urinary incontinence. Patients who required prolonged catheterization after surgery, such as those with a urinary tract infection, bowel injury, or large amount of blood loss, were excluded.

Researchers analyzed data from 55 patients who were randomly assigned to the retrograde-fill group and 54 patients who were randomly assigned to the spontaneous trial group.

In the spontaneous group, patients were required to void at least 150 mL at one time within 6 hours of catheter removal to successfully complete the voiding trial.

In the retrograde-fill group, the bladder was filled in the postanesthesia care unit with 300 mL of saline or until the maximum volume tolerated by the patient (not exceeding 300 mL ) was reached. Patients in this group had to void at least 150 mL or 50% of the instilled volume at one time within 60 minutes of catheter removal to pass the trial.

The researchers documented postvoid residual (PVR) but did not use this measure to determine voiding function.

The baseline demographics of the two groups were similar, although prior hysterectomy was more common in the retrograde-fill group than in the spontaneous group (32.7% vs. 14.8%). The average age was 58.5 years in the retrograde-fill group and 61 years in the spontaneous group.

“There was no significant difference in our primary outcome,” Dr. Popiel said. “There was a 12.7% rate of failed voiding trial in the retrograde group versus 7.7% in the spontaneous group.”

No patients had urinary retention after initially passing their voiding trial. Force of stream did not differ between groups, and about 15% in each group had a postoperative urinary tract infection.

The study demonstrates that voiding assessment based on a spontaneous minimum void of 150 mL is safe and has similar pass rates, compared with the more commonly performed retrograde void trial, Dr. Popiel said. “If the voided amount is at least 150 mL, PVR is not critical to obtain. The study adds to the body of literature that supports less stringent criteria for evaluating voiding function and can limit postoperative urinary recatheterization.”

The investigators allowed patients with PVRs as high as 575 mL to return home without an alternative way to empty the bladder, C. Sage Claydon, MD, a urogynecologist who was not involved in the study, noted during a discussion after the presentation. In all, 6 patients who met the passing criteria for the spontaneous voiding trial had a PVR greater than 200 mL, with volumes ranging from 205-575 mL.

The patients received standardized counseling about postoperative voiding problems, said Dr. Popiel. “This is similar to the work done by Ingber et al. from 2011, where patients who reached a certain force of stream, greater than 5 out of 10, were discharged home regardless of PVR.”

Dr. Popiel had no relevant disclosures. Two coinvestigators disclosed ties to BlossomMed, Renovia, and ArmadaHealth.

[email protected]

SOURCE: Popiel P et al. SGS 2020, Abstract 14.

Uterine leiomyomata (fibroids) are the most common pelvic tumor diagnosed in women.¹ Women with symptomatic fibroids often report abnormal uterine bleeding (AUB) and pelvic cramping, fullness, or pain. Fibroids also may cause frequency of urination and contribute to fertility and pregnancy problems. Treatment options for the AUB caused by fibroids include, but are not limited to, hysterectomy, myomectomy, uterine artery embolization, endometrial ablation, insertion of a levonorgestrel intrauterine device, focused ultrasound surgery, radiofrequency ablation, leuprolide acetate, and elagolix plus low-dose hormone add-back (Oriahnn; AbbVie, North Chicago, Illinois).¹ Oriahnn is the most recent addition to our treatment armamentarium for fibroids and represents the first US Food and Drug Administration (FDA)-approved long-term hormonal option for AUB caused by fibroids.

Gene dysregulation contributes to fibroid development

Most uterine fibroids are clonal tumors, which develop following a somatic mutation in a precursor uterine myocyte. The somatic mutation causes gene dysregulation that stimulates cell growth resulting in a benign tumor mass. The majority of fibroids contain a mutation in one of the following 6 genes: mediator complex subunit 12 (MED12), high mobility group AT-hook (HMGA2 or HMGA1), RAD51B, fumarate hydratase (FH), collagen type IV, alpha 5 chain (COL4A5), or collagen type IV alpha 6 chain (COL4A6).²

Gene dysregulation in fibroids may arise following chromothripsis of the uterine myocyte genome

Chromothripsis is a catastrophic intracellular genetic event in which one or more chromosomes are broken and reassemble in a new nucleic acid sequence, producing a derivative chromosome that contains complex genetic rearrangements.³ Chromothripsis is believed to occur frequently in uterine myocytes. It is unknown why uterine myocytes are susceptible to chromothripsis,³ or why a catastrophic intracellular event such as chromothripsis results in preferential mutations in the 6 genes that are associated with myoma formation.

Estrogen and progesterone influence fibroid size and cell activity

Although uterine fibroids are clonal tumors containing broken genes, they are also exquisitely responsive to estradiol and progesterone. Estradiol and progesterone play an important role in regulating fibroid size and function.⁴ Estrogen stimulates uterine fibroids to increase in size. In a hypoestrogenic state, uterine fibroids decrease in size. In addition, a hypoestrogenic state results in an atrophic endometrium and thereby reduces AUB. For women with uterine fibroids and AUB, a reversible hypoestrogenic state can be induced either with a parenteral GnRH-agonist analogue (leuprolide) or an oral GnRH-antagonist (elagolix). Both leuprolide and elagolix are approved for the treatment of uterine fibroids (see below).

Surprisingly, progesterone stimulates cell division in normal uterine myocytes and fibroid cells.⁵ In the luteal phase of the menstrual cycle, uterine myocyte mitoses are more frequent than in the follicular phase. In addition, synthetic progestins appear to maintain fibroid size in a hypoestrogenic environment. In one randomized trial, women with uterine fibroids treated with leuprolide acetate plus a placebo pill for 24 weeks had a 51% reduction in uterine volume as measured by ultrasound.⁶ Women with uterine fibroids treated with leuprolide acetate plus the synthetic progestin, oral medroxyprogesterone acetate 20 mg daily, had only a 15% reduction in uterine volume.⁶ This finding suggests that synthetic progestins partially block the decrease in uterine volume that occurs in a hypoestrogenic state.

Further evidence that progesterone plays a role in fibroid biology is the observation that treatment of women with uterine fibroids with the antiprogestin ulipristal decreases fibroid size and reduces AUB.^7-9 Ulipristal was approved for the treatment of fibroids in many countries but not the United States. Reports of severe, life-threatening liver injury—some necessitating liver transplantation—among women using ulipristal prompted the European Medicines Agency (EMA) in 2020 to recommend that women stop taking ulipristal. In addition, the EMA recommended that no woman should initiate ulipristal treatment at this time.¹⁰

Continue to: Leuprolide acetate...

Leuprolide acetate

Leuprolide acetate is a peptide GnRH-agonist analogue. Initiation of leuprolide treatment stimulates gonadotropin release, but with chronic administration pituitary secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) decreases, resulting in reduced ovarian follicular activity, anovulation, and low serum concentration of estradiol and progesterone. Leuprolide treatment concomitant with iron therapy is approved by the FDA for improving red blood cell volume prior to surgery in women with fibroids, AUB, and anemia.¹¹ Among women with fibroids, AUB, and anemia, after 12 weeks of treatment, the hemoglobin concentration was ≥12 g/dL in 79% treated with leuprolide plus iron and 56% treated with iron alone.¹¹ The FDA recommends limiting preoperative leuprolide treatment to no more than 3 months. The approved leuprolide regimens are a maximum of 3 monthly injections of leuprolide 3.75 mg or a single injection of leuprolide 11.25 mg. Leuprolide treatment prior to hysterectomy surgery for uterine fibroids usually will result in a decrease in uterine size and may facilitate vaginal hysterectomy.

Elagolix plus estradiol plus norethindrone acetate (Oriahnn)

GnRH analogues cause a hypoestrogenic state resulting in adverse effects, including moderate to severe hot flashes and a reduction in bone mineral density. One approach to reducing the unwanted effects of hot flashes and decreased bone density is to combine a GnRH analogue with low-dose steroid hormone add-back therapy. Combining a GnRH analogue with low-dose steroid hormone add-back permits long-term treatment of AUB caused by fibroids, with few hot flashes and a minimal decrease in bone mineral density. The FDA recently has approved the combination of elagolix plus low-dose estradiol and norethindrone acetate (Oriahnn) for the long-term treatment of AUB caused by fibroids.

Elagolix is a nonpeptide oral GnRH antagonist that reduces pituitary secretion of LH and FSH, resulting in a decrease in ovarian follicular activity, anovulation, and low serum concentration of estradiol and progesterone. Unlike leuprolide, which causes an initial increase in LH and FSH secretion, the initiation of elagolix treatment causes an immediate and sustained reduction in LH and FSH secretion. Combining elagolix with a low dose of estradiol and norethindrone acetate reduces the side effects of hot flashes and decreased bone density. Clinical trials have reported that the combination of elagolix (300 mg) twice daily plus estradiol (1 mg) and norethindrone acetate (0.5 mg) once daily is an effective long-term treatment of AUB caused by uterine fibroids.

To study the efficacy of elagolix (alone or with estrogen-progestin add-back therapy) for the treatment of AUB caused by uterine fibroids, two identical trials were performed,¹² in which 790 women participated. The participants had a mean age of 42 years and were documented to have heavy menstrual bleeding (>80 mL blood loss per cycle) and ultrasound-diagnosed uterine fibroids. The participants were randomized to one of 3 groups:

• elagolix (300 mg twice daily) plus low-dose steroid add-back (1 mg estradiol and 0.5 mg norethindrone acetate once daily),
• elagolix 300 mg twice daily with no steroid add-back (elagolix alone), or
• placebo for 6 months.¹²

Menstrual blood loss was quantified using the alkaline hematin method on collected sanitary products. The primary endpoint was menstrual blood loss <80 mL per cycle as well as a ≥50% reduction in quantified blood loss from baseline during the final month of treatment. At 6 months, the percentage of women achieving the primary endpoint in the first trial was 84% (elagolix alone), 69% (elagolix plus add-back), and 9% (placebo). Mean changes from baseline in lumbar spine bone density were −2.95% (elagolix alone), −0.76% (elagolix plus add-back), and −0.21% (placebo). The percentage of women reporting hot flashes was 64% in the elagolix group, 20% in the elagolix plus low-dose steroid add-back group, and 9% in the placebo group. Results were similar in the second trial.¹²

The initial trials were extended to 12 months with two groups: elagolix 300 mg twice daily plus low-dose hormone add-back with 1 mg estradiol and 0.5 mg norethindrone acetate once daily (n = 218) or elagolix 300 mg twice daily (elagolix alone) (n = 98).¹³ Following 12 months of treatment, heavy menstrual bleeding was controlled in 88% and 89% of women treated with elagolix plus add-back and elagolix alone, respectively. Amenorrhea was reported by 65% of the women in the elagolix plus add-back group. Compared with baseline bone density, at the end of 12 months of treatment, bone mineral density in the lumbar spine was reduced by -1.5% and -4.8% in the women treated with elagolix plus add-back and elagolix alone, respectively. Compared with baseline bone density, at 1 year following completion of treatment, bone mineral density in the lumbar spine was reduced by -0.6% and -2.0% in the women treated with elagolix plus add-back and elagolix alone, respectively. Similar trends were observed in total hip and femoral neck bone density. During treatment with elagolix plus add-back, adverse effects were modest, including hot flushes (6%), night sweats (3.2%), headache (5.5%), and nausea (4.1%). Two women developed liver transaminase levels >3 times the upper limit of normal, resulting in one woman discontinuing treatment.¹³

Continue to: Contraindications to Oriahnn include known allergies...

Contraindications to Oriahnn include known allergies to the components of the medication (including the yellow dye tartrazine); high risk of arterial, venous thrombotic or thromboembolic disorders; pregnancy; known osteoporosis; current breast cancer or other hormonally-sensitive malignancies; known liver disease; and concurrent use of organic anion transporting polypeptide 1B1 inhibitors, which includes many HIV antiviral medications.¹⁴ Undiagnosed AUB is a contraindication, and all women prescribed Oriahnn should have endometrial sampling before initiating treatment. Oriahnn should not be used for more than 24 months due to the risk of irreversible bone loss.¹⁴ Systemic estrogen and progestin combinations, a component of Oriahnn, increases the risk for pulmonary embolism, deep vein thrombosis, stroke, and myocardial infarction, especially in women at increased risk for these events (such as women >35 years who smoke cigarettes and women with uncontrolled hypertension).¹⁴ In two studies there was a higher incidence of depression, depressed mood, and/or tearfulness in women taking Oriahnn (3%) compared with those taking a placebo (1%).¹⁴ The FDA recommends promptly evaluating women with depressive symptoms to determine the risks of initiating and continuing Oriahnn therapy. In two studies there was a higher risk of reported alopecia among women taking Oriahnn (3.5%) compared with placebo (1%).¹⁴

It should be noted that elagolix is approved for the treatment of pelvic pain caused by endometriosis at a dose of 150 mg daily for 24 months or 200 mg twice daily for 6 months. The elagolix dose for the treatment of AUB caused by fibroids is 300 mg twice daily for up to 24 months, necessitating the addition of low-dose estradiol-norethindrone add-back to reduce the frequency and severity of hot flashes and minimize the loss of bone density. Norethindrone acetate also protects the endometrium from the stimulatory effect of estradiol, reducing the risk of developing endometrial hyperplasia and cancer. Oriahnn is formulated as two different capsules. A yellow and white capsule contains elagolix 300 mg plus estradiol 1 mg and norethindrone acetate 0.5 mg to be taken in the morning, and a blue and white capsule contains elagolix 300 mg to be taken in the evening.

AUB caused by fibroids is a common problem in gyn practice

There are many procedural interventions that are effective in reducing AUB caused by fibroids. However, prior to the approval of Oriahnn there were no hormonal medications that were FDA approved for the long-term treatment of AUB caused by fibroids. Hence, Oriahnn represents an important advance in the hormonal treatment of AUB caused by fibroids and expands the treatment options available to our patients. ●

Uterine leiomyomata (fibroids) are the most common pelvic tumor diagnosed in women.¹ Women with symptomatic fibroids often report abnormal uterine bleeding (AUB) and pelvic cramping, fullness, or pain. Fibroids also may cause frequency of urination and contribute to fertility and pregnancy problems. Treatment options for the AUB caused by fibroids include, but are not limited to, hysterectomy, myomectomy, uterine artery embolization, endometrial ablation, insertion of a levonorgestrel intrauterine device, focused ultrasound surgery, radiofrequency ablation, leuprolide acetate, and elagolix plus low-dose hormone add-back (Oriahnn; AbbVie, North Chicago, Illinois).¹ Oriahnn is the most recent addition to our treatment armamentarium for fibroids and represents the first US Food and Drug Administration (FDA)-approved long-term hormonal option for AUB caused by fibroids.

Gene dysregulation contributes to fibroid development

Most uterine fibroids are clonal tumors, which develop following a somatic mutation in a precursor uterine myocyte. The somatic mutation causes gene dysregulation that stimulates cell growth resulting in a benign tumor mass. The majority of fibroids contain a mutation in one of the following 6 genes: mediator complex subunit 12 (MED12), high mobility group AT-hook (HMGA2 or HMGA1), RAD51B, fumarate hydratase (FH), collagen type IV, alpha 5 chain (COL4A5), or collagen type IV alpha 6 chain (COL4A6).²

Gene dysregulation in fibroids may arise following chromothripsis of the uterine myocyte genome

Chromothripsis is a catastrophic intracellular genetic event in which one or more chromosomes are broken and reassemble in a new nucleic acid sequence, producing a derivative chromosome that contains complex genetic rearrangements.³ Chromothripsis is believed to occur frequently in uterine myocytes. It is unknown why uterine myocytes are susceptible to chromothripsis,³ or why a catastrophic intracellular event such as chromothripsis results in preferential mutations in the 6 genes that are associated with myoma formation.

Estrogen and progesterone influence fibroid size and cell activity

Although uterine fibroids are clonal tumors containing broken genes, they are also exquisitely responsive to estradiol and progesterone. Estradiol and progesterone play an important role in regulating fibroid size and function.⁴ Estrogen stimulates uterine fibroids to increase in size. In a hypoestrogenic state, uterine fibroids decrease in size. In addition, a hypoestrogenic state results in an atrophic endometrium and thereby reduces AUB. For women with uterine fibroids and AUB, a reversible hypoestrogenic state can be induced either with a parenteral GnRH-agonist analogue (leuprolide) or an oral GnRH-antagonist (elagolix). Both leuprolide and elagolix are approved for the treatment of uterine fibroids (see below).

Surprisingly, progesterone stimulates cell division in normal uterine myocytes and fibroid cells.⁵ In the luteal phase of the menstrual cycle, uterine myocyte mitoses are more frequent than in the follicular phase. In addition, synthetic progestins appear to maintain fibroid size in a hypoestrogenic environment. In one randomized trial, women with uterine fibroids treated with leuprolide acetate plus a placebo pill for 24 weeks had a 51% reduction in uterine volume as measured by ultrasound.⁶ Women with uterine fibroids treated with leuprolide acetate plus the synthetic progestin, oral medroxyprogesterone acetate 20 mg daily, had only a 15% reduction in uterine volume.⁶ This finding suggests that synthetic progestins partially block the decrease in uterine volume that occurs in a hypoestrogenic state.

Further evidence that progesterone plays a role in fibroid biology is the observation that treatment of women with uterine fibroids with the antiprogestin ulipristal decreases fibroid size and reduces AUB.^7-9 Ulipristal was approved for the treatment of fibroids in many countries but not the United States. Reports of severe, life-threatening liver injury—some necessitating liver transplantation—among women using ulipristal prompted the European Medicines Agency (EMA) in 2020 to recommend that women stop taking ulipristal. In addition, the EMA recommended that no woman should initiate ulipristal treatment at this time.¹⁰

Continue to: Leuprolide acetate...

Leuprolide acetate

Leuprolide acetate is a peptide GnRH-agonist analogue. Initiation of leuprolide treatment stimulates gonadotropin release, but with chronic administration pituitary secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) decreases, resulting in reduced ovarian follicular activity, anovulation, and low serum concentration of estradiol and progesterone. Leuprolide treatment concomitant with iron therapy is approved by the FDA for improving red blood cell volume prior to surgery in women with fibroids, AUB, and anemia.¹¹ Among women with fibroids, AUB, and anemia, after 12 weeks of treatment, the hemoglobin concentration was ≥12 g/dL in 79% treated with leuprolide plus iron and 56% treated with iron alone.¹¹ The FDA recommends limiting preoperative leuprolide treatment to no more than 3 months. The approved leuprolide regimens are a maximum of 3 monthly injections of leuprolide 3.75 mg or a single injection of leuprolide 11.25 mg. Leuprolide treatment prior to hysterectomy surgery for uterine fibroids usually will result in a decrease in uterine size and may facilitate vaginal hysterectomy.

Elagolix plus estradiol plus norethindrone acetate (Oriahnn)

GnRH analogues cause a hypoestrogenic state resulting in adverse effects, including moderate to severe hot flashes and a reduction in bone mineral density. One approach to reducing the unwanted effects of hot flashes and decreased bone density is to combine a GnRH analogue with low-dose steroid hormone add-back therapy. Combining a GnRH analogue with low-dose steroid hormone add-back permits long-term treatment of AUB caused by fibroids, with few hot flashes and a minimal decrease in bone mineral density. The FDA recently has approved the combination of elagolix plus low-dose estradiol and norethindrone acetate (Oriahnn) for the long-term treatment of AUB caused by fibroids.

Elagolix is a nonpeptide oral GnRH antagonist that reduces pituitary secretion of LH and FSH, resulting in a decrease in ovarian follicular activity, anovulation, and low serum concentration of estradiol and progesterone. Unlike leuprolide, which causes an initial increase in LH and FSH secretion, the initiation of elagolix treatment causes an immediate and sustained reduction in LH and FSH secretion. Combining elagolix with a low dose of estradiol and norethindrone acetate reduces the side effects of hot flashes and decreased bone density. Clinical trials have reported that the combination of elagolix (300 mg) twice daily plus estradiol (1 mg) and norethindrone acetate (0.5 mg) once daily is an effective long-term treatment of AUB caused by uterine fibroids.

To study the efficacy of elagolix (alone or with estrogen-progestin add-back therapy) for the treatment of AUB caused by uterine fibroids, two identical trials were performed,¹² in which 790 women participated. The participants had a mean age of 42 years and were documented to have heavy menstrual bleeding (>80 mL blood loss per cycle) and ultrasound-diagnosed uterine fibroids. The participants were randomized to one of 3 groups:

• elagolix (300 mg twice daily) plus low-dose steroid add-back (1 mg estradiol and 0.5 mg norethindrone acetate once daily),
• elagolix 300 mg twice daily with no steroid add-back (elagolix alone), or
• placebo for 6 months.¹²

Menstrual blood loss was quantified using the alkaline hematin method on collected sanitary products. The primary endpoint was menstrual blood loss <80 mL per cycle as well as a ≥50% reduction in quantified blood loss from baseline during the final month of treatment. At 6 months, the percentage of women achieving the primary endpoint in the first trial was 84% (elagolix alone), 69% (elagolix plus add-back), and 9% (placebo). Mean changes from baseline in lumbar spine bone density were −2.95% (elagolix alone), −0.76% (elagolix plus add-back), and −0.21% (placebo). The percentage of women reporting hot flashes was 64% in the elagolix group, 20% in the elagolix plus low-dose steroid add-back group, and 9% in the placebo group. Results were similar in the second trial.¹²

The initial trials were extended to 12 months with two groups: elagolix 300 mg twice daily plus low-dose hormone add-back with 1 mg estradiol and 0.5 mg norethindrone acetate once daily (n = 218) or elagolix 300 mg twice daily (elagolix alone) (n = 98).¹³ Following 12 months of treatment, heavy menstrual bleeding was controlled in 88% and 89% of women treated with elagolix plus add-back and elagolix alone, respectively. Amenorrhea was reported by 65% of the women in the elagolix plus add-back group. Compared with baseline bone density, at the end of 12 months of treatment, bone mineral density in the lumbar spine was reduced by -1.5% and -4.8% in the women treated with elagolix plus add-back and elagolix alone, respectively. Compared with baseline bone density, at 1 year following completion of treatment, bone mineral density in the lumbar spine was reduced by -0.6% and -2.0% in the women treated with elagolix plus add-back and elagolix alone, respectively. Similar trends were observed in total hip and femoral neck bone density. During treatment with elagolix plus add-back, adverse effects were modest, including hot flushes (6%), night sweats (3.2%), headache (5.5%), and nausea (4.1%). Two women developed liver transaminase levels >3 times the upper limit of normal, resulting in one woman discontinuing treatment.¹³

Continue to: Contraindications to Oriahnn include known allergies...

Contraindications to Oriahnn include known allergies to the components of the medication (including the yellow dye tartrazine); high risk of arterial, venous thrombotic or thromboembolic disorders; pregnancy; known osteoporosis; current breast cancer or other hormonally-sensitive malignancies; known liver disease; and concurrent use of organic anion transporting polypeptide 1B1 inhibitors, which includes many HIV antiviral medications.¹⁴ Undiagnosed AUB is a contraindication, and all women prescribed Oriahnn should have endometrial sampling before initiating treatment. Oriahnn should not be used for more than 24 months due to the risk of irreversible bone loss.¹⁴ Systemic estrogen and progestin combinations, a component of Oriahnn, increases the risk for pulmonary embolism, deep vein thrombosis, stroke, and myocardial infarction, especially in women at increased risk for these events (such as women >35 years who smoke cigarettes and women with uncontrolled hypertension).¹⁴ In two studies there was a higher incidence of depression, depressed mood, and/or tearfulness in women taking Oriahnn (3%) compared with those taking a placebo (1%).¹⁴ The FDA recommends promptly evaluating women with depressive symptoms to determine the risks of initiating and continuing Oriahnn therapy. In two studies there was a higher risk of reported alopecia among women taking Oriahnn (3.5%) compared with placebo (1%).¹⁴

It should be noted that elagolix is approved for the treatment of pelvic pain caused by endometriosis at a dose of 150 mg daily for 24 months or 200 mg twice daily for 6 months. The elagolix dose for the treatment of AUB caused by fibroids is 300 mg twice daily for up to 24 months, necessitating the addition of low-dose estradiol-norethindrone add-back to reduce the frequency and severity of hot flashes and minimize the loss of bone density. Norethindrone acetate also protects the endometrium from the stimulatory effect of estradiol, reducing the risk of developing endometrial hyperplasia and cancer. Oriahnn is formulated as two different capsules. A yellow and white capsule contains elagolix 300 mg plus estradiol 1 mg and norethindrone acetate 0.5 mg to be taken in the morning, and a blue and white capsule contains elagolix 300 mg to be taken in the evening.

AUB caused by fibroids is a common problem in gyn practice

There are many procedural interventions that are effective in reducing AUB caused by fibroids. However, prior to the approval of Oriahnn there were no hormonal medications that were FDA approved for the long-term treatment of AUB caused by fibroids. Hence, Oriahnn represents an important advance in the hormonal treatment of AUB caused by fibroids and expands the treatment options available to our patients. ●

Uterine leiomyomata (fibroids) are the most common pelvic tumor diagnosed in women.¹ Women with symptomatic fibroids often report abnormal uterine bleeding (AUB) and pelvic cramping, fullness, or pain. Fibroids also may cause frequency of urination and contribute to fertility and pregnancy problems. Treatment options for the AUB caused by fibroids include, but are not limited to, hysterectomy, myomectomy, uterine artery embolization, endometrial ablation, insertion of a levonorgestrel intrauterine device, focused ultrasound surgery, radiofrequency ablation, leuprolide acetate, and elagolix plus low-dose hormone add-back (Oriahnn; AbbVie, North Chicago, Illinois).¹ Oriahnn is the most recent addition to our treatment armamentarium for fibroids and represents the first US Food and Drug Administration (FDA)-approved long-term hormonal option for AUB caused by fibroids.

Gene dysregulation contributes to fibroid development

Most uterine fibroids are clonal tumors, which develop following a somatic mutation in a precursor uterine myocyte. The somatic mutation causes gene dysregulation that stimulates cell growth resulting in a benign tumor mass. The majority of fibroids contain a mutation in one of the following 6 genes: mediator complex subunit 12 (MED12), high mobility group AT-hook (HMGA2 or HMGA1), RAD51B, fumarate hydratase (FH), collagen type IV, alpha 5 chain (COL4A5), or collagen type IV alpha 6 chain (COL4A6).²

Gene dysregulation in fibroids may arise following chromothripsis of the uterine myocyte genome

Chromothripsis is a catastrophic intracellular genetic event in which one or more chromosomes are broken and reassemble in a new nucleic acid sequence, producing a derivative chromosome that contains complex genetic rearrangements.³ Chromothripsis is believed to occur frequently in uterine myocytes. It is unknown why uterine myocytes are susceptible to chromothripsis,³ or why a catastrophic intracellular event such as chromothripsis results in preferential mutations in the 6 genes that are associated with myoma formation.

Estrogen and progesterone influence fibroid size and cell activity

Although uterine fibroids are clonal tumors containing broken genes, they are also exquisitely responsive to estradiol and progesterone. Estradiol and progesterone play an important role in regulating fibroid size and function.⁴ Estrogen stimulates uterine fibroids to increase in size. In a hypoestrogenic state, uterine fibroids decrease in size. In addition, a hypoestrogenic state results in an atrophic endometrium and thereby reduces AUB. For women with uterine fibroids and AUB, a reversible hypoestrogenic state can be induced either with a parenteral GnRH-agonist analogue (leuprolide) or an oral GnRH-antagonist (elagolix). Both leuprolide and elagolix are approved for the treatment of uterine fibroids (see below).

Surprisingly, progesterone stimulates cell division in normal uterine myocytes and fibroid cells.⁵ In the luteal phase of the menstrual cycle, uterine myocyte mitoses are more frequent than in the follicular phase. In addition, synthetic progestins appear to maintain fibroid size in a hypoestrogenic environment. In one randomized trial, women with uterine fibroids treated with leuprolide acetate plus a placebo pill for 24 weeks had a 51% reduction in uterine volume as measured by ultrasound.⁶ Women with uterine fibroids treated with leuprolide acetate plus the synthetic progestin, oral medroxyprogesterone acetate 20 mg daily, had only a 15% reduction in uterine volume.⁶ This finding suggests that synthetic progestins partially block the decrease in uterine volume that occurs in a hypoestrogenic state.

Further evidence that progesterone plays a role in fibroid biology is the observation that treatment of women with uterine fibroids with the antiprogestin ulipristal decreases fibroid size and reduces AUB.^7-9 Ulipristal was approved for the treatment of fibroids in many countries but not the United States. Reports of severe, life-threatening liver injury—some necessitating liver transplantation—among women using ulipristal prompted the European Medicines Agency (EMA) in 2020 to recommend that women stop taking ulipristal. In addition, the EMA recommended that no woman should initiate ulipristal treatment at this time.¹⁰

Continue to: Leuprolide acetate...

Leuprolide acetate

Leuprolide acetate is a peptide GnRH-agonist analogue. Initiation of leuprolide treatment stimulates gonadotropin release, but with chronic administration pituitary secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) decreases, resulting in reduced ovarian follicular activity, anovulation, and low serum concentration of estradiol and progesterone. Leuprolide treatment concomitant with iron therapy is approved by the FDA for improving red blood cell volume prior to surgery in women with fibroids, AUB, and anemia.¹¹ Among women with fibroids, AUB, and anemia, after 12 weeks of treatment, the hemoglobin concentration was ≥12 g/dL in 79% treated with leuprolide plus iron and 56% treated with iron alone.¹¹ The FDA recommends limiting preoperative leuprolide treatment to no more than 3 months. The approved leuprolide regimens are a maximum of 3 monthly injections of leuprolide 3.75 mg or a single injection of leuprolide 11.25 mg. Leuprolide treatment prior to hysterectomy surgery for uterine fibroids usually will result in a decrease in uterine size and may facilitate vaginal hysterectomy.

Elagolix plus estradiol plus norethindrone acetate (Oriahnn)

GnRH analogues cause a hypoestrogenic state resulting in adverse effects, including moderate to severe hot flashes and a reduction in bone mineral density. One approach to reducing the unwanted effects of hot flashes and decreased bone density is to combine a GnRH analogue with low-dose steroid hormone add-back therapy. Combining a GnRH analogue with low-dose steroid hormone add-back permits long-term treatment of AUB caused by fibroids, with few hot flashes and a minimal decrease in bone mineral density. The FDA recently has approved the combination of elagolix plus low-dose estradiol and norethindrone acetate (Oriahnn) for the long-term treatment of AUB caused by fibroids.

Elagolix is a nonpeptide oral GnRH antagonist that reduces pituitary secretion of LH and FSH, resulting in a decrease in ovarian follicular activity, anovulation, and low serum concentration of estradiol and progesterone. Unlike leuprolide, which causes an initial increase in LH and FSH secretion, the initiation of elagolix treatment causes an immediate and sustained reduction in LH and FSH secretion. Combining elagolix with a low dose of estradiol and norethindrone acetate reduces the side effects of hot flashes and decreased bone density. Clinical trials have reported that the combination of elagolix (300 mg) twice daily plus estradiol (1 mg) and norethindrone acetate (0.5 mg) once daily is an effective long-term treatment of AUB caused by uterine fibroids.

To study the efficacy of elagolix (alone or with estrogen-progestin add-back therapy) for the treatment of AUB caused by uterine fibroids, two identical trials were performed,¹² in which 790 women participated. The participants had a mean age of 42 years and were documented to have heavy menstrual bleeding (>80 mL blood loss per cycle) and ultrasound-diagnosed uterine fibroids. The participants were randomized to one of 3 groups:

• elagolix (300 mg twice daily) plus low-dose steroid add-back (1 mg estradiol and 0.5 mg norethindrone acetate once daily),
• elagolix 300 mg twice daily with no steroid add-back (elagolix alone), or
• placebo for 6 months.¹²

Menstrual blood loss was quantified using the alkaline hematin method on collected sanitary products. The primary endpoint was menstrual blood loss <80 mL per cycle as well as a ≥50% reduction in quantified blood loss from baseline during the final month of treatment. At 6 months, the percentage of women achieving the primary endpoint in the first trial was 84% (elagolix alone), 69% (elagolix plus add-back), and 9% (placebo). Mean changes from baseline in lumbar spine bone density were −2.95% (elagolix alone), −0.76% (elagolix plus add-back), and −0.21% (placebo). The percentage of women reporting hot flashes was 64% in the elagolix group, 20% in the elagolix plus low-dose steroid add-back group, and 9% in the placebo group. Results were similar in the second trial.¹²

The initial trials were extended to 12 months with two groups: elagolix 300 mg twice daily plus low-dose hormone add-back with 1 mg estradiol and 0.5 mg norethindrone acetate once daily (n = 218) or elagolix 300 mg twice daily (elagolix alone) (n = 98).¹³ Following 12 months of treatment, heavy menstrual bleeding was controlled in 88% and 89% of women treated with elagolix plus add-back and elagolix alone, respectively. Amenorrhea was reported by 65% of the women in the elagolix plus add-back group. Compared with baseline bone density, at the end of 12 months of treatment, bone mineral density in the lumbar spine was reduced by -1.5% and -4.8% in the women treated with elagolix plus add-back and elagolix alone, respectively. Compared with baseline bone density, at 1 year following completion of treatment, bone mineral density in the lumbar spine was reduced by -0.6% and -2.0% in the women treated with elagolix plus add-back and elagolix alone, respectively. Similar trends were observed in total hip and femoral neck bone density. During treatment with elagolix plus add-back, adverse effects were modest, including hot flushes (6%), night sweats (3.2%), headache (5.5%), and nausea (4.1%). Two women developed liver transaminase levels >3 times the upper limit of normal, resulting in one woman discontinuing treatment.¹³

Continue to: Contraindications to Oriahnn include known allergies...

Contraindications to Oriahnn include known allergies to the components of the medication (including the yellow dye tartrazine); high risk of arterial, venous thrombotic or thromboembolic disorders; pregnancy; known osteoporosis; current breast cancer or other hormonally-sensitive malignancies; known liver disease; and concurrent use of organic anion transporting polypeptide 1B1 inhibitors, which includes many HIV antiviral medications.¹⁴ Undiagnosed AUB is a contraindication, and all women prescribed Oriahnn should have endometrial sampling before initiating treatment. Oriahnn should not be used for more than 24 months due to the risk of irreversible bone loss.¹⁴ Systemic estrogen and progestin combinations, a component of Oriahnn, increases the risk for pulmonary embolism, deep vein thrombosis, stroke, and myocardial infarction, especially in women at increased risk for these events (such as women >35 years who smoke cigarettes and women with uncontrolled hypertension).¹⁴ In two studies there was a higher incidence of depression, depressed mood, and/or tearfulness in women taking Oriahnn (3%) compared with those taking a placebo (1%).¹⁴ The FDA recommends promptly evaluating women with depressive symptoms to determine the risks of initiating and continuing Oriahnn therapy. In two studies there was a higher risk of reported alopecia among women taking Oriahnn (3.5%) compared with placebo (1%).¹⁴

It should be noted that elagolix is approved for the treatment of pelvic pain caused by endometriosis at a dose of 150 mg daily for 24 months or 200 mg twice daily for 6 months. The elagolix dose for the treatment of AUB caused by fibroids is 300 mg twice daily for up to 24 months, necessitating the addition of low-dose estradiol-norethindrone add-back to reduce the frequency and severity of hot flashes and minimize the loss of bone density. Norethindrone acetate also protects the endometrium from the stimulatory effect of estradiol, reducing the risk of developing endometrial hyperplasia and cancer. Oriahnn is formulated as two different capsules. A yellow and white capsule contains elagolix 300 mg plus estradiol 1 mg and norethindrone acetate 0.5 mg to be taken in the morning, and a blue and white capsule contains elagolix 300 mg to be taken in the evening.

AUB caused by fibroids is a common problem in gyn practice

There are many procedural interventions that are effective in reducing AUB caused by fibroids. However, prior to the approval of Oriahnn there were no hormonal medications that were FDA approved for the long-term treatment of AUB caused by fibroids. Hence, Oriahnn represents an important advance in the hormonal treatment of AUB caused by fibroids and expands the treatment options available to our patients. ●

How do you feel about expectantly managing a well-dated pregnancy past 41 weeks’ gestation?

ROBERT L. BARBIERI, MD

(EDITORIAL; FEBRUARY 2019) 

Is it reasonable to choose the age of 40 for proposing an anticipation of labor induction?

In physiologic ongoing pregnancies (whether they are spontaneous or autologous in vitro fertilization [IVF] or heterologous IVF), the evidence for anticipating labor induction based upon the only factor of age (after 40 years) is missing. Nonetheless, the number of women becoming pregnant at an older age is expected to increase, and from my perspective, to induce all physiologic pregnancies at term by 41 weeks and 5 days’ gestation does not appear to be best practice. I favor the idea of all women aged 40 and older to start labor induction earlier (for instance, to offer labor induction, with proper informed consent, by 41+ 0 and not 41+ 5 through 42+ 0 weeks of pregnancy).

Luca Bernardini, MD

La Spezia, Italy 

Dr. Barbieri responds

At Brigham and Women’s Hospital in Boston, Massachusetts, our approach is to offer women ≥40 years of age induction of labor (IOL) at 39 weeks’ gestation, unless there is an obstetric contraindication to IOL. We believe that IOL at 39 weeks’ gestation is associated with a reduced risk of both cesarean delivery and a new diagnosis of hypertension.¹

Reference

1. Grobman WA, Rice MM, Reddy, UM, et al. Labor induction versus expectant management in low-risk nulliparous women. N Engl J Med. 2018;379:513-523.

What is the optimal hormonal treatment for women with polycystic ovary syndrome?

ROBERT L. BARBIERI, MD

(EDITORIAL; JANUARY 2020)

OCs and spironolactone study

I often recommend oral contraceptives (OCs) containing drospirenone for patients with polycyctic ovary syndrome (PCOS)-associated mild acne and hirsutism—since OCs are already approved by the US Food and Drug Administration for acne, with similar effects as spironolactone. My patients seem to do well on an OC, and require only one medication. Of course, I would add spironolactone to the treatment regimen and switch OCs if she was not responding well.

Michael T. Cane, MD

Arlington, Texas

Dr. Barbieri responds

The Endocrine Society agrees with Dr. Cane’s approach, recommending the initiation of monotherapy with an estrogen-progestin followed by the addition of spironolactone if 6 months of monotherapy produces insufficient improvement in dermatologic symptoms of PCOS, including hirsutism and acne. Most contraceptives contain 3 mg or 4 mg of drospirenone, which is thought to have antiandrogenic effects similar to spironolactone 25 mg. I believe that spironolactone 100 mg provides more complete and rapid resolution of the dermatologic symptoms caused by PCOS. Hence, I initiate both an estrogen-progestin contraceptive with spironolactone.

How do you feel about expectantly managing a well-dated pregnancy past 41 weeks’ gestation?

ROBERT L. BARBIERI, MD

(EDITORIAL; FEBRUARY 2019) 

Is it reasonable to choose the age of 40 for proposing an anticipation of labor induction?

In physiologic ongoing pregnancies (whether they are spontaneous or autologous in vitro fertilization [IVF] or heterologous IVF), the evidence for anticipating labor induction based upon the only factor of age (after 40 years) is missing. Nonetheless, the number of women becoming pregnant at an older age is expected to increase, and from my perspective, to induce all physiologic pregnancies at term by 41 weeks and 5 days’ gestation does not appear to be best practice. I favor the idea of all women aged 40 and older to start labor induction earlier (for instance, to offer labor induction, with proper informed consent, by 41+ 0 and not 41+ 5 through 42+ 0 weeks of pregnancy).

Luca Bernardini, MD

La Spezia, Italy 

Dr. Barbieri responds

At Brigham and Women’s Hospital in Boston, Massachusetts, our approach is to offer women ≥40 years of age induction of labor (IOL) at 39 weeks’ gestation, unless there is an obstetric contraindication to IOL. We believe that IOL at 39 weeks’ gestation is associated with a reduced risk of both cesarean delivery and a new diagnosis of hypertension.¹

Reference

1. Grobman WA, Rice MM, Reddy, UM, et al. Labor induction versus expectant management in low-risk nulliparous women. N Engl J Med. 2018;379:513-523.

What is the optimal hormonal treatment for women with polycystic ovary syndrome?

ROBERT L. BARBIERI, MD

(EDITORIAL; JANUARY 2020)

OCs and spironolactone study

I often recommend oral contraceptives (OCs) containing drospirenone for patients with polycyctic ovary syndrome (PCOS)-associated mild acne and hirsutism—since OCs are already approved by the US Food and Drug Administration for acne, with similar effects as spironolactone. My patients seem to do well on an OC, and require only one medication. Of course, I would add spironolactone to the treatment regimen and switch OCs if she was not responding well.

Michael T. Cane, MD

Arlington, Texas

Dr. Barbieri responds

The Endocrine Society agrees with Dr. Cane’s approach, recommending the initiation of monotherapy with an estrogen-progestin followed by the addition of spironolactone if 6 months of monotherapy produces insufficient improvement in dermatologic symptoms of PCOS, including hirsutism and acne. Most contraceptives contain 3 mg or 4 mg of drospirenone, which is thought to have antiandrogenic effects similar to spironolactone 25 mg. I believe that spironolactone 100 mg provides more complete and rapid resolution of the dermatologic symptoms caused by PCOS. Hence, I initiate both an estrogen-progestin contraceptive with spironolactone.

How do you feel about expectantly managing a well-dated pregnancy past 41 weeks’ gestation?

ROBERT L. BARBIERI, MD

(EDITORIAL; FEBRUARY 2019) 

Is it reasonable to choose the age of 40 for proposing an anticipation of labor induction?

In physiologic ongoing pregnancies (whether they are spontaneous or autologous in vitro fertilization [IVF] or heterologous IVF), the evidence for anticipating labor induction based upon the only factor of age (after 40 years) is missing. Nonetheless, the number of women becoming pregnant at an older age is expected to increase, and from my perspective, to induce all physiologic pregnancies at term by 41 weeks and 5 days’ gestation does not appear to be best practice. I favor the idea of all women aged 40 and older to start labor induction earlier (for instance, to offer labor induction, with proper informed consent, by 41+ 0 and not 41+ 5 through 42+ 0 weeks of pregnancy).

Luca Bernardini, MD

La Spezia, Italy 

Dr. Barbieri responds

At Brigham and Women’s Hospital in Boston, Massachusetts, our approach is to offer women ≥40 years of age induction of labor (IOL) at 39 weeks’ gestation, unless there is an obstetric contraindication to IOL. We believe that IOL at 39 weeks’ gestation is associated with a reduced risk of both cesarean delivery and a new diagnosis of hypertension.¹

Reference

1. Grobman WA, Rice MM, Reddy, UM, et al. Labor induction versus expectant management in low-risk nulliparous women. N Engl J Med. 2018;379:513-523.

What is the optimal hormonal treatment for women with polycystic ovary syndrome?

ROBERT L. BARBIERI, MD

(EDITORIAL; JANUARY 2020)

OCs and spironolactone study

I often recommend oral contraceptives (OCs) containing drospirenone for patients with polycyctic ovary syndrome (PCOS)-associated mild acne and hirsutism—since OCs are already approved by the US Food and Drug Administration for acne, with similar effects as spironolactone. My patients seem to do well on an OC, and require only one medication. Of course, I would add spironolactone to the treatment regimen and switch OCs if she was not responding well.

Michael T. Cane, MD

Arlington, Texas

Dr. Barbieri responds

The Endocrine Society agrees with Dr. Cane’s approach, recommending the initiation of monotherapy with an estrogen-progestin followed by the addition of spironolactone if 6 months of monotherapy produces insufficient improvement in dermatologic symptoms of PCOS, including hirsutism and acne. Most contraceptives contain 3 mg or 4 mg of drospirenone, which is thought to have antiandrogenic effects similar to spironolactone 25 mg. I believe that spironolactone 100 mg provides more complete and rapid resolution of the dermatologic symptoms caused by PCOS. Hence, I initiate both an estrogen-progestin contraceptive with spironolactone.

Women facing issues related to perimenopause and menopause can consult their primary care physicians or ob.gyns. through telemedicine visits, but a new online portal, the Cusp, offers an alternative model with a focus on menopause and access to experts for a monthly membership fee.

The Cusp doesn’t claim to replace routine gynecologic care. Rather, it focuses on perimenopause and menopause symptoms specifically, and states that its physicians, some of whom are certified by the North American Menopause Society, provide expertise in menopause beyond what patients might receive as part of a typical ob.gyn. visit.

The Cusp is a for-profit organization, a group of physicians, nurse practitioners, and technologists who focus on integrated care for women in perimenopause and beyond. The aim is to leverage technology as a way to connect women to the care platform to book physician and nurse practitioner visits virtually and to have all of the information about their care centralized in one place.

According to the website, most patients who sign up for a care plan check in with their providers at least once a month to monitor their symptoms and tweak treatment strategies. Patients who sign up are prompted to download an app, which then becomes the main tool for scheduling future visits, tracking symptoms, and communicating with providers.

The Cusp launched in early 2019, before the advent of the COVID-19 pandemic, but the pandemic has accelerated the acceptance across medical specialties, suggesting that telemedicine is here to stay, according to Mindy Goldman, MD, professor of gynecology and gynecologic surgery at the University of California, San Francisco, and director of the Gynecology Center for Cancer Survivors and At-Risk Women at UCSF, who also serves as a medical adviser to the Cusp.

Partnering with technology companies allows opportunities to provide care in areas where there are gaps, such as menopause management, she said. Many clinicians in primary care and ob.gyn. care don’t have the time or training to discuss menopause management in depth with patients, and patient interviews conducted by the Cusp before launching the site showed that this was an area of need.

“One thing that is really unique about the Cusp is that we brought together experts to provide care in both in an evidence-based and holistic fashion,” Dr. Goldman emphasized.

The Cusp’s medical team includes physician and nurse practitioner menopause experts with backgrounds including not only ob.gyn. but also psychiatry, integrative medicine, and naturopathic medicine, with plans to add endocrinology and dermatology as well. This holistic approach allows the Cusp to tailor care based on what each woman is looking for, with evidence-based expertise to support treatment decisions, said Dr. Goldman, whose advisory role includes helping to develop patient treatment protocols and services.

If a woman wants to begin treating symptoms with a naturopathic approach, the team will provide protocols that take current guidelines into account. Regular visits, approximately once a month or as needed, allow for collaboration with the Cusp’s specialists to provide consistent care that is very comprehensive, she said.

One of the benefits of the Cusp is the opportunity for “frequent touchpoints” in which providers reach out to patients via text, email, or video. Although a traditional medical visit may include some initial discussion of menopause and treatment plans, the Cusp offers “a more seamless way to address needs on an ongoing basis,” to provide more complete patient care, Dr. Goldman said.

“We are constantly asking women what they are looking for in menopause care,” and a recurring question was about hormone testing, she said. Nontraditional practitioners may offer hormone testing as a way of individualizing care that also involves compounded formulations, and other treatments that are not standard of care. “In all of our protocols we follow what is recommended by standard organizations such as ACOG [American College of Obstetricians and Gynecologists] and NAMS.”

The Cusp’s newest service is an at-home hormone test currently for women in New York and California, but the company plans to expand this service. The hormone test, while not essential, is another tool to guide menopause management, and having a sense of when menopause will occur “gives us a chance to talk to people about behavioral changes and time to personalize a treatment protocol,” Dr. Goldman said.

The test is based in part on the anti-Müllerian hormone, which recent studies have shown is useful in predicting time to menopause. This, in combination with other hormone tests and other clinical information, will allow the Cusp’s menopause specialists to help women in perimenopause gain perspective on their symptoms and design a treatment plan that can evolve as their needs change, she explained.

“The more information you know about when menopause is going to be happening, you can tailor your treatment plan,” Dr. Goldman said. For example, a woman who may be 2 years away from menopause might consider a naturopathic approach at first, and switch to a different therapy as menopause occurs. “We know that the risks of cardiovascular disease and bone loss increase after menopause, and knowing the time to menopause gives us more guidance when educating patients about healthy lifestyle habits such as exercise and dietary changes that can help reduce these risks.”

The Cusp allows patients to use money in flexible spending accounts or health savings accounts to pay for the program. If doctors require lab tests or other procedures, these are covered through the patients’ regular health insurance as they would be if requested by a primary care physician or other health care professional.

Lubna Pal, MBBS, director of the menopause program at Yale University, New Haven, Conn., commented that part of the value in a telehealth site such as the Cusp is to serve as “a resource for reproductively aging women to understand what is happening to them.”

Any way to improve education on the topic of menopause is empowering to women, said Dr. Pal, professor of obstetrics, gynecology, and reproductive sciences at Yale. “This is an opportunity for patients to have access to a directed evaluation” of menopause-related symptoms. Then, when women visit their regular health care provider in person, they are well-equipped with knowledge to ask more informed questions and discuss a wide range of treatment options.

Dr. Pal noted that the hormone test is less valuable than the interaction between physicians and patients, whether online or in person.

“Menopause is a Monday morning quarterback diagnosis,” she said, emphasizing that, not only is a year without menses part of the diagnosis of menopause, many women in perimenopause can have wide fluctuations in hormone levels, so a test is more of a snapshot than a diagnostic tool, and that the results might cause unnecessary angst and concerns for patients.

However, part of the value of a telehealth site that focuses on menopause is that it gives women a place to learn more about their biology and to clarify their questions about symptoms and become aware of a range of treatment options. Telehealth consultations also can help women recognize how other factors such as lifestyle modifications can play a role in menopause symptoms, and how modifying these factors may provide some relief, she said.

Dr. Pal said she would be cautious about the idea of prescribing without seeing the patient in person, but noted that telehealth sites such as the Cusp can be a win-win to enhance women’s health when used in combination with regular in-person visits to an ob.gyn. The added value in patients’ being able to discuss their concerns and to learn more about their symptoms means that they will be better informed to develop a menopause management strategy in partnership with their providers, said Dr. Pal, who is not associated with the Cusp.

Dr. Goldman disclosed receiving compensation from the Cusp for her advisory work. She also holds stock options in the company. Dr. Pal, who is a member of the Ob.Gyn. News editorial advisory board, had no financial conflicts to disclose.

Women facing issues related to perimenopause and menopause can consult their primary care physicians or ob.gyns. through telemedicine visits, but a new online portal, the Cusp, offers an alternative model with a focus on menopause and access to experts for a monthly membership fee.

The Cusp doesn’t claim to replace routine gynecologic care. Rather, it focuses on perimenopause and menopause symptoms specifically, and states that its physicians, some of whom are certified by the North American Menopause Society, provide expertise in menopause beyond what patients might receive as part of a typical ob.gyn. visit.

The Cusp is a for-profit organization, a group of physicians, nurse practitioners, and technologists who focus on integrated care for women in perimenopause and beyond. The aim is to leverage technology as a way to connect women to the care platform to book physician and nurse practitioner visits virtually and to have all of the information about their care centralized in one place.

According to the website, most patients who sign up for a care plan check in with their providers at least once a month to monitor their symptoms and tweak treatment strategies. Patients who sign up are prompted to download an app, which then becomes the main tool for scheduling future visits, tracking symptoms, and communicating with providers.

The Cusp launched in early 2019, before the advent of the COVID-19 pandemic, but the pandemic has accelerated the acceptance across medical specialties, suggesting that telemedicine is here to stay, according to Mindy Goldman, MD, professor of gynecology and gynecologic surgery at the University of California, San Francisco, and director of the Gynecology Center for Cancer Survivors and At-Risk Women at UCSF, who also serves as a medical adviser to the Cusp.

Partnering with technology companies allows opportunities to provide care in areas where there are gaps, such as menopause management, she said. Many clinicians in primary care and ob.gyn. care don’t have the time or training to discuss menopause management in depth with patients, and patient interviews conducted by the Cusp before launching the site showed that this was an area of need.

“One thing that is really unique about the Cusp is that we brought together experts to provide care in both in an evidence-based and holistic fashion,” Dr. Goldman emphasized.

The Cusp’s medical team includes physician and nurse practitioner menopause experts with backgrounds including not only ob.gyn. but also psychiatry, integrative medicine, and naturopathic medicine, with plans to add endocrinology and dermatology as well. This holistic approach allows the Cusp to tailor care based on what each woman is looking for, with evidence-based expertise to support treatment decisions, said Dr. Goldman, whose advisory role includes helping to develop patient treatment protocols and services.

If a woman wants to begin treating symptoms with a naturopathic approach, the team will provide protocols that take current guidelines into account. Regular visits, approximately once a month or as needed, allow for collaboration with the Cusp’s specialists to provide consistent care that is very comprehensive, she said.

One of the benefits of the Cusp is the opportunity for “frequent touchpoints” in which providers reach out to patients via text, email, or video. Although a traditional medical visit may include some initial discussion of menopause and treatment plans, the Cusp offers “a more seamless way to address needs on an ongoing basis,” to provide more complete patient care, Dr. Goldman said.

“We are constantly asking women what they are looking for in menopause care,” and a recurring question was about hormone testing, she said. Nontraditional practitioners may offer hormone testing as a way of individualizing care that also involves compounded formulations, and other treatments that are not standard of care. “In all of our protocols we follow what is recommended by standard organizations such as ACOG [American College of Obstetricians and Gynecologists] and NAMS.”

The Cusp’s newest service is an at-home hormone test currently for women in New York and California, but the company plans to expand this service. The hormone test, while not essential, is another tool to guide menopause management, and having a sense of when menopause will occur “gives us a chance to talk to people about behavioral changes and time to personalize a treatment protocol,” Dr. Goldman said.

The test is based in part on the anti-Müllerian hormone, which recent studies have shown is useful in predicting time to menopause. This, in combination with other hormone tests and other clinical information, will allow the Cusp’s menopause specialists to help women in perimenopause gain perspective on their symptoms and design a treatment plan that can evolve as their needs change, she explained.

“The more information you know about when menopause is going to be happening, you can tailor your treatment plan,” Dr. Goldman said. For example, a woman who may be 2 years away from menopause might consider a naturopathic approach at first, and switch to a different therapy as menopause occurs. “We know that the risks of cardiovascular disease and bone loss increase after menopause, and knowing the time to menopause gives us more guidance when educating patients about healthy lifestyle habits such as exercise and dietary changes that can help reduce these risks.”

The Cusp allows patients to use money in flexible spending accounts or health savings accounts to pay for the program. If doctors require lab tests or other procedures, these are covered through the patients’ regular health insurance as they would be if requested by a primary care physician or other health care professional.

Lubna Pal, MBBS, director of the menopause program at Yale University, New Haven, Conn., commented that part of the value in a telehealth site such as the Cusp is to serve as “a resource for reproductively aging women to understand what is happening to them.”

Any way to improve education on the topic of menopause is empowering to women, said Dr. Pal, professor of obstetrics, gynecology, and reproductive sciences at Yale. “This is an opportunity for patients to have access to a directed evaluation” of menopause-related symptoms. Then, when women visit their regular health care provider in person, they are well-equipped with knowledge to ask more informed questions and discuss a wide range of treatment options.

Dr. Pal noted that the hormone test is less valuable than the interaction between physicians and patients, whether online or in person.

“Menopause is a Monday morning quarterback diagnosis,” she said, emphasizing that, not only is a year without menses part of the diagnosis of menopause, many women in perimenopause can have wide fluctuations in hormone levels, so a test is more of a snapshot than a diagnostic tool, and that the results might cause unnecessary angst and concerns for patients.

However, part of the value of a telehealth site that focuses on menopause is that it gives women a place to learn more about their biology and to clarify their questions about symptoms and become aware of a range of treatment options. Telehealth consultations also can help women recognize how other factors such as lifestyle modifications can play a role in menopause symptoms, and how modifying these factors may provide some relief, she said.

Dr. Pal said she would be cautious about the idea of prescribing without seeing the patient in person, but noted that telehealth sites such as the Cusp can be a win-win to enhance women’s health when used in combination with regular in-person visits to an ob.gyn. The added value in patients’ being able to discuss their concerns and to learn more about their symptoms means that they will be better informed to develop a menopause management strategy in partnership with their providers, said Dr. Pal, who is not associated with the Cusp.

Dr. Goldman disclosed receiving compensation from the Cusp for her advisory work. She also holds stock options in the company. Dr. Pal, who is a member of the Ob.Gyn. News editorial advisory board, had no financial conflicts to disclose.

Women facing issues related to perimenopause and menopause can consult their primary care physicians or ob.gyns. through telemedicine visits, but a new online portal, the Cusp, offers an alternative model with a focus on menopause and access to experts for a monthly membership fee.

The Cusp doesn’t claim to replace routine gynecologic care. Rather, it focuses on perimenopause and menopause symptoms specifically, and states that its physicians, some of whom are certified by the North American Menopause Society, provide expertise in menopause beyond what patients might receive as part of a typical ob.gyn. visit.

The Cusp is a for-profit organization, a group of physicians, nurse practitioners, and technologists who focus on integrated care for women in perimenopause and beyond. The aim is to leverage technology as a way to connect women to the care platform to book physician and nurse practitioner visits virtually and to have all of the information about their care centralized in one place.

According to the website, most patients who sign up for a care plan check in with their providers at least once a month to monitor their symptoms and tweak treatment strategies. Patients who sign up are prompted to download an app, which then becomes the main tool for scheduling future visits, tracking symptoms, and communicating with providers.

The Cusp launched in early 2019, before the advent of the COVID-19 pandemic, but the pandemic has accelerated the acceptance across medical specialties, suggesting that telemedicine is here to stay, according to Mindy Goldman, MD, professor of gynecology and gynecologic surgery at the University of California, San Francisco, and director of the Gynecology Center for Cancer Survivors and At-Risk Women at UCSF, who also serves as a medical adviser to the Cusp.

Partnering with technology companies allows opportunities to provide care in areas where there are gaps, such as menopause management, she said. Many clinicians in primary care and ob.gyn. care don’t have the time or training to discuss menopause management in depth with patients, and patient interviews conducted by the Cusp before launching the site showed that this was an area of need.

“One thing that is really unique about the Cusp is that we brought together experts to provide care in both in an evidence-based and holistic fashion,” Dr. Goldman emphasized.

The Cusp’s medical team includes physician and nurse practitioner menopause experts with backgrounds including not only ob.gyn. but also psychiatry, integrative medicine, and naturopathic medicine, with plans to add endocrinology and dermatology as well. This holistic approach allows the Cusp to tailor care based on what each woman is looking for, with evidence-based expertise to support treatment decisions, said Dr. Goldman, whose advisory role includes helping to develop patient treatment protocols and services.

If a woman wants to begin treating symptoms with a naturopathic approach, the team will provide protocols that take current guidelines into account. Regular visits, approximately once a month or as needed, allow for collaboration with the Cusp’s specialists to provide consistent care that is very comprehensive, she said.

One of the benefits of the Cusp is the opportunity for “frequent touchpoints” in which providers reach out to patients via text, email, or video. Although a traditional medical visit may include some initial discussion of menopause and treatment plans, the Cusp offers “a more seamless way to address needs on an ongoing basis,” to provide more complete patient care, Dr. Goldman said.

“We are constantly asking women what they are looking for in menopause care,” and a recurring question was about hormone testing, she said. Nontraditional practitioners may offer hormone testing as a way of individualizing care that also involves compounded formulations, and other treatments that are not standard of care. “In all of our protocols we follow what is recommended by standard organizations such as ACOG [American College of Obstetricians and Gynecologists] and NAMS.”

The Cusp’s newest service is an at-home hormone test currently for women in New York and California, but the company plans to expand this service. The hormone test, while not essential, is another tool to guide menopause management, and having a sense of when menopause will occur “gives us a chance to talk to people about behavioral changes and time to personalize a treatment protocol,” Dr. Goldman said.

The test is based in part on the anti-Müllerian hormone, which recent studies have shown is useful in predicting time to menopause. This, in combination with other hormone tests and other clinical information, will allow the Cusp’s menopause specialists to help women in perimenopause gain perspective on their symptoms and design a treatment plan that can evolve as their needs change, she explained.

“The more information you know about when menopause is going to be happening, you can tailor your treatment plan,” Dr. Goldman said. For example, a woman who may be 2 years away from menopause might consider a naturopathic approach at first, and switch to a different therapy as menopause occurs. “We know that the risks of cardiovascular disease and bone loss increase after menopause, and knowing the time to menopause gives us more guidance when educating patients about healthy lifestyle habits such as exercise and dietary changes that can help reduce these risks.”

The Cusp allows patients to use money in flexible spending accounts or health savings accounts to pay for the program. If doctors require lab tests or other procedures, these are covered through the patients’ regular health insurance as they would be if requested by a primary care physician or other health care professional.

Lubna Pal, MBBS, director of the menopause program at Yale University, New Haven, Conn., commented that part of the value in a telehealth site such as the Cusp is to serve as “a resource for reproductively aging women to understand what is happening to them.”

Any way to improve education on the topic of menopause is empowering to women, said Dr. Pal, professor of obstetrics, gynecology, and reproductive sciences at Yale. “This is an opportunity for patients to have access to a directed evaluation” of menopause-related symptoms. Then, when women visit their regular health care provider in person, they are well-equipped with knowledge to ask more informed questions and discuss a wide range of treatment options.

Dr. Pal noted that the hormone test is less valuable than the interaction between physicians and patients, whether online or in person.

“Menopause is a Monday morning quarterback diagnosis,” she said, emphasizing that, not only is a year without menses part of the diagnosis of menopause, many women in perimenopause can have wide fluctuations in hormone levels, so a test is more of a snapshot than a diagnostic tool, and that the results might cause unnecessary angst and concerns for patients.

However, part of the value of a telehealth site that focuses on menopause is that it gives women a place to learn more about their biology and to clarify their questions about symptoms and become aware of a range of treatment options. Telehealth consultations also can help women recognize how other factors such as lifestyle modifications can play a role in menopause symptoms, and how modifying these factors may provide some relief, she said.

Dr. Pal said she would be cautious about the idea of prescribing without seeing the patient in person, but noted that telehealth sites such as the Cusp can be a win-win to enhance women’s health when used in combination with regular in-person visits to an ob.gyn. The added value in patients’ being able to discuss their concerns and to learn more about their symptoms means that they will be better informed to develop a menopause management strategy in partnership with their providers, said Dr. Pal, who is not associated with the Cusp.

Dr. Goldman disclosed receiving compensation from the Cusp for her advisory work. She also holds stock options in the company. Dr. Pal, who is a member of the Ob.Gyn. News editorial advisory board, had no financial conflicts to disclose.

Among women who have a coincidental appendectomy during surgery for chronic pelvic pain or endometriosis, about 15% have appendiceal endometriosis confirmed by pathological examination, according to a study.

“In the women with appendiceal endometriosis, only 26% had an appendix that looked abnormal,” said Whitney T. Ross, MD, of the department of obstetrics and gynecology at Penn State Health, Hershey.

The results, presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons, indicate that “appendiceal endometriosis is common in women receiving surgery for chronic pelvic pain or endometriosis,” she said. “This study and multiple other studies have also demonstrated that coincidental appendectomy is safe.”

The long-term impact of coincidental appendectomy and its effect on quality of life are not known, however, which may make it difficult to weigh the costs and benefits of the procedure, Dr. Ross said. “It is important to talk to patients about this procedure and determine which approach is the right approach for your institution.”

The study of 609 coincidental appendectomies did not include patients with retrocecal appendices, which may confound the true rate of appendiceal endometriosis, commented Saifuddin T. Mama, MD, MPH, of Rowan University, Camden, N.J.

When the investigators started the study, they were not sure of the risks and benefits of the procedure in patients with retrocecal appendices. An anecdotal report from another research group suggests that outcomes with retrocecal appendices may not be significantly different. “But that is certainly an important question and one that we would like to address in a future prospective study,” Dr. Ross said.

Surgeons have debated the role of coincidental appendectomy during gynecologic surgery. Concerns about safety and questions about the prevalence of appendiceal pathology are reasons that coincidental appendectomy has not been more widely adopted. On the other hand, the procedure may benefit patients and aid diagnosis.

To evaluate the role of coincidental appendectomy in the surgical excision of endometriosis, Dr. Ross and colleagues analyzed data from consecutive coincidental appendectomies performed at one institution between 2013 and 2019. They identified cases in a prospectively maintained surgical database to assess safety and the prevalence of appendiceal pathology.

iStockphoto.com

The indication for surgery was chronic pelvic pain but no visualized endometriosis for 42 patients, stage I-II endometriosis for 388 patients, and stage III-IV endometriosis for 179 patients.

Surgeries included laparoscopic hysterectomy (77.5%), operative laparoscopy (19.9%), and laparoscopic trachelectomy (2.6%). Pathological analysis of the appendices identified endometriosis in 14.9%, malignancy in 0.7%, polyps in 0.5%, and appendicitis in 0.3%.

Among women with chronic pelvic pain but no visualized endometriosis, 2.4% had appendiceal endometriosis. Among those with stage I-II endometriosis, 7% had appendiceal endometriosis, and in patients with stage III-IV endometriosis, the rate of appendiceal endometriosis was 35.2%.

In about 6% of patients with appendiceal endometriosis, the appendix was the only site of pathologically confirmed endometriosis.

Compared with chronic pelvic pain, stage III-IV endometriosis was associated with a significantly increased risk of appendiceal endometriosis (odds ratio, 22.2). The likelihood of appendiceal endometriosis also increased when the appendix looked abnormal (odds ratio, 6.5).

The probability of diagnosing appendiceal endometriosis also increases with the number of other locations of confirmed endometriosis.

“Our surgical decision making is based off of intraoperative findings. However, the final gold-standard diagnosis can’t take place until the pathologic specimen is analyzed,” she said. “We also know that there is a significant discordance, as high as 50%, in early-stage endometriosis between visual inspection and pathology findings.”

There were no complications related to the performance of a coincidental appendectomy during surgery or in the 12 weeks after.

Dr. Ross outlined surgeons’ three main options for performing coincidental appendectomy in patients undergoing surgery for chronic pelvic pain or endometriosis: universal coincidental appendectomy, targeted appendectomy based on operative findings, and performing the procedure based on the appearance of the appendix.

Basing the decision on appearance “is going to miss a lot of appendiceal endometriosis,” Dr. Ross said. In the present study, 67 of the 91 cases, about 74%, would have been missed.

Dr. Ross and Dr. Mama had no relevant financial disclosures. The study coauthors disclosed ties to Titan Medical, Merck, and AbbVie.

[email protected]

SOURCE: Ross WT et al. SGS 2020, Abstract 14.

Among women who have a coincidental appendectomy during surgery for chronic pelvic pain or endometriosis, about 15% have appendiceal endometriosis confirmed by pathological examination, according to a study.

“In the women with appendiceal endometriosis, only 26% had an appendix that looked abnormal,” said Whitney T. Ross, MD, of the department of obstetrics and gynecology at Penn State Health, Hershey.

The results, presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons, indicate that “appendiceal endometriosis is common in women receiving surgery for chronic pelvic pain or endometriosis,” she said. “This study and multiple other studies have also demonstrated that coincidental appendectomy is safe.”

The long-term impact of coincidental appendectomy and its effect on quality of life are not known, however, which may make it difficult to weigh the costs and benefits of the procedure, Dr. Ross said. “It is important to talk to patients about this procedure and determine which approach is the right approach for your institution.”

The study of 609 coincidental appendectomies did not include patients with retrocecal appendices, which may confound the true rate of appendiceal endometriosis, commented Saifuddin T. Mama, MD, MPH, of Rowan University, Camden, N.J.

When the investigators started the study, they were not sure of the risks and benefits of the procedure in patients with retrocecal appendices. An anecdotal report from another research group suggests that outcomes with retrocecal appendices may not be significantly different. “But that is certainly an important question and one that we would like to address in a future prospective study,” Dr. Ross said.

Surgeons have debated the role of coincidental appendectomy during gynecologic surgery. Concerns about safety and questions about the prevalence of appendiceal pathology are reasons that coincidental appendectomy has not been more widely adopted. On the other hand, the procedure may benefit patients and aid diagnosis.

To evaluate the role of coincidental appendectomy in the surgical excision of endometriosis, Dr. Ross and colleagues analyzed data from consecutive coincidental appendectomies performed at one institution between 2013 and 2019. They identified cases in a prospectively maintained surgical database to assess safety and the prevalence of appendiceal pathology.

iStockphoto.com

The indication for surgery was chronic pelvic pain but no visualized endometriosis for 42 patients, stage I-II endometriosis for 388 patients, and stage III-IV endometriosis for 179 patients.

Surgeries included laparoscopic hysterectomy (77.5%), operative laparoscopy (19.9%), and laparoscopic trachelectomy (2.6%). Pathological analysis of the appendices identified endometriosis in 14.9%, malignancy in 0.7%, polyps in 0.5%, and appendicitis in 0.3%.

Among women with chronic pelvic pain but no visualized endometriosis, 2.4% had appendiceal endometriosis. Among those with stage I-II endometriosis, 7% had appendiceal endometriosis, and in patients with stage III-IV endometriosis, the rate of appendiceal endometriosis was 35.2%.

In about 6% of patients with appendiceal endometriosis, the appendix was the only site of pathologically confirmed endometriosis.

Compared with chronic pelvic pain, stage III-IV endometriosis was associated with a significantly increased risk of appendiceal endometriosis (odds ratio, 22.2). The likelihood of appendiceal endometriosis also increased when the appendix looked abnormal (odds ratio, 6.5).

The probability of diagnosing appendiceal endometriosis also increases with the number of other locations of confirmed endometriosis.

“Our surgical decision making is based off of intraoperative findings. However, the final gold-standard diagnosis can’t take place until the pathologic specimen is analyzed,” she said. “We also know that there is a significant discordance, as high as 50%, in early-stage endometriosis between visual inspection and pathology findings.”

There were no complications related to the performance of a coincidental appendectomy during surgery or in the 12 weeks after.

Dr. Ross outlined surgeons’ three main options for performing coincidental appendectomy in patients undergoing surgery for chronic pelvic pain or endometriosis: universal coincidental appendectomy, targeted appendectomy based on operative findings, and performing the procedure based on the appearance of the appendix.

Basing the decision on appearance “is going to miss a lot of appendiceal endometriosis,” Dr. Ross said. In the present study, 67 of the 91 cases, about 74%, would have been missed.

Dr. Ross and Dr. Mama had no relevant financial disclosures. The study coauthors disclosed ties to Titan Medical, Merck, and AbbVie.

[email protected]

SOURCE: Ross WT et al. SGS 2020, Abstract 14.

Among women who have a coincidental appendectomy during surgery for chronic pelvic pain or endometriosis, about 15% have appendiceal endometriosis confirmed by pathological examination, according to a study.

“In the women with appendiceal endometriosis, only 26% had an appendix that looked abnormal,” said Whitney T. Ross, MD, of the department of obstetrics and gynecology at Penn State Health, Hershey.

The results, presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons, indicate that “appendiceal endometriosis is common in women receiving surgery for chronic pelvic pain or endometriosis,” she said. “This study and multiple other studies have also demonstrated that coincidental appendectomy is safe.”

The long-term impact of coincidental appendectomy and its effect on quality of life are not known, however, which may make it difficult to weigh the costs and benefits of the procedure, Dr. Ross said. “It is important to talk to patients about this procedure and determine which approach is the right approach for your institution.”

The study of 609 coincidental appendectomies did not include patients with retrocecal appendices, which may confound the true rate of appendiceal endometriosis, commented Saifuddin T. Mama, MD, MPH, of Rowan University, Camden, N.J.

When the investigators started the study, they were not sure of the risks and benefits of the procedure in patients with retrocecal appendices. An anecdotal report from another research group suggests that outcomes with retrocecal appendices may not be significantly different. “But that is certainly an important question and one that we would like to address in a future prospective study,” Dr. Ross said.

Surgeons have debated the role of coincidental appendectomy during gynecologic surgery. Concerns about safety and questions about the prevalence of appendiceal pathology are reasons that coincidental appendectomy has not been more widely adopted. On the other hand, the procedure may benefit patients and aid diagnosis.

To evaluate the role of coincidental appendectomy in the surgical excision of endometriosis, Dr. Ross and colleagues analyzed data from consecutive coincidental appendectomies performed at one institution between 2013 and 2019. They identified cases in a prospectively maintained surgical database to assess safety and the prevalence of appendiceal pathology.

iStockphoto.com

The indication for surgery was chronic pelvic pain but no visualized endometriosis for 42 patients, stage I-II endometriosis for 388 patients, and stage III-IV endometriosis for 179 patients.

Surgeries included laparoscopic hysterectomy (77.5%), operative laparoscopy (19.9%), and laparoscopic trachelectomy (2.6%). Pathological analysis of the appendices identified endometriosis in 14.9%, malignancy in 0.7%, polyps in 0.5%, and appendicitis in 0.3%.

Among women with chronic pelvic pain but no visualized endometriosis, 2.4% had appendiceal endometriosis. Among those with stage I-II endometriosis, 7% had appendiceal endometriosis, and in patients with stage III-IV endometriosis, the rate of appendiceal endometriosis was 35.2%.

In about 6% of patients with appendiceal endometriosis, the appendix was the only site of pathologically confirmed endometriosis.

Compared with chronic pelvic pain, stage III-IV endometriosis was associated with a significantly increased risk of appendiceal endometriosis (odds ratio, 22.2). The likelihood of appendiceal endometriosis also increased when the appendix looked abnormal (odds ratio, 6.5).

The probability of diagnosing appendiceal endometriosis also increases with the number of other locations of confirmed endometriosis.

“Our surgical decision making is based off of intraoperative findings. However, the final gold-standard diagnosis can’t take place until the pathologic specimen is analyzed,” she said. “We also know that there is a significant discordance, as high as 50%, in early-stage endometriosis between visual inspection and pathology findings.”

There were no complications related to the performance of a coincidental appendectomy during surgery or in the 12 weeks after.

Dr. Ross outlined surgeons’ three main options for performing coincidental appendectomy in patients undergoing surgery for chronic pelvic pain or endometriosis: universal coincidental appendectomy, targeted appendectomy based on operative findings, and performing the procedure based on the appearance of the appendix.

Basing the decision on appearance “is going to miss a lot of appendiceal endometriosis,” Dr. Ross said. In the present study, 67 of the 91 cases, about 74%, would have been missed.

Dr. Ross and Dr. Mama had no relevant financial disclosures. The study coauthors disclosed ties to Titan Medical, Merck, and AbbVie.

[email protected]

SOURCE: Ross WT et al. SGS 2020, Abstract 14.

Women undergoing vaginal surgery have better physical function after 6 weeks when they are positioned in boot stirrups rather than candy cane stirrups, according to the first randomized controlled trial comparing both types of lithotomy stirrups.

“Participants positioned in candy cane stirrups had greater hip abduction than those positioned in boot stirrups, which could provide a rationale for our findings,” suggested Ankita Gupta, MD, MPH, of the University of Louisville (Ky.), and colleagues. Their report is in Obstetrics & Gynecology.

But one expert questions this interpretation, calling it a major limitation of the study.

“The only difference between the two arms of the study is associated with the angles between the femurs,” said Rosanne M. Kho, MD, a gynecologic surgeon at Cleveland Clinic, who was not involved in the study. “The difference of the angles at the femur is not inherent to the type of stirrup but in the method in which the patients were positioned using the two different types of stirrups,” she said. “The same wide angle between the femurs can be attained with the boot stirrups if the patient is not positioned properly. To determine if the same benefit in physical function is achieved with a lesser angle between the femur, the investigators should use only one type of stirrup (whether the candy cane or the boot stirrups) and change only the angles of the femur.”

The study was a single-masked, randomized controlled trial of women undergoing vaginal surgery at the University of Louisville’s division of urogynecology between March 2018 and Oct. 2019. Surgeries included any combination of vaginal hysterectomy, vaginal vault suspension (uterosacral or sacrospinous ligament fixation), vaginectomy (partial or total), mid-urethral slings, or other surgeries such as urethral diverticulectomy, fistula repair, or mesh excision.

Among the 138 women included in the intention-to-treat analysis, 72 were randomized to candy cane, and 66 to boot (Yellofin) stirrups. They were positioned in the assigned stirrup by the attending surgeon, with assistance from the surgical team, after administration of anesthesia and were not informed of their allocation until the end of the study at 6 weeks post surgery.

On day 1 post surgery, a 100-point visual analog scale (VAS) questionnaire was administered for pain in the lower back, hips, buttocks, thighs, knees, calves, and feet, followed by a series of questionnaires at 6 weeks post surgery, including the PROMIS (Patient-Reported Outcomes Measurement Information System) forms on physical function, pain intensity, and pain interference, as well as the Pelvic Floor Disability Index (PFDI-20) and the Patient Global Impression of Improvement forms.

While the authors acknowledged that neurologic injuries following vaginal surgery are rare, and therefore difficult to measure, physical function is a “prudent” alternative measurement.

Although the study was designed to compare lithotomy stirrups, patient positioning also was measured. Once the patient was anesthetized, the surgeon used a goniometer to measure flexion at the hip and knee joints, the angle of abduction and external rotation at the hip. The “angle between the femurs” was measured by placing the fulcrum of the goniometer at the anal opening.

While the angles of flexion at the hips and knees were similar between groups, the study found a significant difference between groups in the angle between the femurs (mean ± standard deviation, 88.7 ± 13.4 candy cane vs. 77.2 ± 13.3 boot, P < .01).

In addition, the primary outcome, change in physical function based on the PROMIS physical function shortform-20a, was significantly different between the two groups: While subjects in the candy cane group demonstrated a decline of 1.9 in mean physical function score at 6 weeks compared to baseline, those in the boot stirrup group showed an increase of 1.9 from baseline. The mean 6-week postoperative scores were 45.8 versus 49.8 for the candy cane and boot stirrup groups respectively (P < .01).

Although it was “well executed by a well-respected group of vaginal surgeons at a major academic institution,” the study has other limitations, noted Dr. Kho.

“Though the measurements were obtained with the goniometer at the beginning of the surgery, it does not appear that a repeat measurement was performed at the end of the case. Is it possible that positioning could have shifted and resulted in further change in the angle of the femur/hip/knees compared to the beginning of the surgery?” she asked.

In addition, “compared to the candy canes, the boot stirrup has bulky boots that could limit opportunities for bedside assistants who were standing next to the primary surgeon to lean against the patient’s thighs during the surgery. Were there measures done to ensure that assistants were not leaning against the [candy cane] patients?”

In terms of the 6-week outcome measure, Dr. Kho suggested PROMIS outcomes measured at 2 weeks and at 4 or 6 weeks “would have provided greater insight to the study question.

“The authors acknowledge that neuropathies due to patient positioning manifest soon after surgery and tend to be transient. Incidence of neuropathy is extremely low in both groups and is equivalent. Factors that could impair quick return to normal activity as a result of the neuromuscular effects due to patient positioning should have been measured earlier,” she suggested.

Finally, Dr. Kho noted that the authors “fail to provide any likely rationale for the impaired physical function measured at 6 weeks that can be attributed to the difference in the angles at the femur. The findings of decreased physical function at 6 weeks in the candy cane group may be incidental, and may be different if measured at an earlier time (which would be more pertinent for this study) or at a later time such as 3 months.”

Individual authors acknowledged personal funds from Society of Gynecologic Surgeons, Elsevier publishing, RBI Medical, and AMAG Pharmaceuticals. Dr. Kho had no relevant financial disclosures.

SOURCE: Gupta A et al. Obstet Gynecol. 2020 July 8. doi: 10.1097/AOG.0000000000003954.

Women undergoing vaginal surgery have better physical function after 6 weeks when they are positioned in boot stirrups rather than candy cane stirrups, according to the first randomized controlled trial comparing both types of lithotomy stirrups.

“Participants positioned in candy cane stirrups had greater hip abduction than those positioned in boot stirrups, which could provide a rationale for our findings,” suggested Ankita Gupta, MD, MPH, of the University of Louisville (Ky.), and colleagues. Their report is in Obstetrics & Gynecology.

But one expert questions this interpretation, calling it a major limitation of the study.

“The only difference between the two arms of the study is associated with the angles between the femurs,” said Rosanne M. Kho, MD, a gynecologic surgeon at Cleveland Clinic, who was not involved in the study. “The difference of the angles at the femur is not inherent to the type of stirrup but in the method in which the patients were positioned using the two different types of stirrups,” she said. “The same wide angle between the femurs can be attained with the boot stirrups if the patient is not positioned properly. To determine if the same benefit in physical function is achieved with a lesser angle between the femur, the investigators should use only one type of stirrup (whether the candy cane or the boot stirrups) and change only the angles of the femur.”

The study was a single-masked, randomized controlled trial of women undergoing vaginal surgery at the University of Louisville’s division of urogynecology between March 2018 and Oct. 2019. Surgeries included any combination of vaginal hysterectomy, vaginal vault suspension (uterosacral or sacrospinous ligament fixation), vaginectomy (partial or total), mid-urethral slings, or other surgeries such as urethral diverticulectomy, fistula repair, or mesh excision.

Among the 138 women included in the intention-to-treat analysis, 72 were randomized to candy cane, and 66 to boot (Yellofin) stirrups. They were positioned in the assigned stirrup by the attending surgeon, with assistance from the surgical team, after administration of anesthesia and were not informed of their allocation until the end of the study at 6 weeks post surgery.

On day 1 post surgery, a 100-point visual analog scale (VAS) questionnaire was administered for pain in the lower back, hips, buttocks, thighs, knees, calves, and feet, followed by a series of questionnaires at 6 weeks post surgery, including the PROMIS (Patient-Reported Outcomes Measurement Information System) forms on physical function, pain intensity, and pain interference, as well as the Pelvic Floor Disability Index (PFDI-20) and the Patient Global Impression of Improvement forms.

While the authors acknowledged that neurologic injuries following vaginal surgery are rare, and therefore difficult to measure, physical function is a “prudent” alternative measurement.

Although the study was designed to compare lithotomy stirrups, patient positioning also was measured. Once the patient was anesthetized, the surgeon used a goniometer to measure flexion at the hip and knee joints, the angle of abduction and external rotation at the hip. The “angle between the femurs” was measured by placing the fulcrum of the goniometer at the anal opening.

While the angles of flexion at the hips and knees were similar between groups, the study found a significant difference between groups in the angle between the femurs (mean ± standard deviation, 88.7 ± 13.4 candy cane vs. 77.2 ± 13.3 boot, P < .01).

In addition, the primary outcome, change in physical function based on the PROMIS physical function shortform-20a, was significantly different between the two groups: While subjects in the candy cane group demonstrated a decline of 1.9 in mean physical function score at 6 weeks compared to baseline, those in the boot stirrup group showed an increase of 1.9 from baseline. The mean 6-week postoperative scores were 45.8 versus 49.8 for the candy cane and boot stirrup groups respectively (P < .01).

Although it was “well executed by a well-respected group of vaginal surgeons at a major academic institution,” the study has other limitations, noted Dr. Kho.

“Though the measurements were obtained with the goniometer at the beginning of the surgery, it does not appear that a repeat measurement was performed at the end of the case. Is it possible that positioning could have shifted and resulted in further change in the angle of the femur/hip/knees compared to the beginning of the surgery?” she asked.

In addition, “compared to the candy canes, the boot stirrup has bulky boots that could limit opportunities for bedside assistants who were standing next to the primary surgeon to lean against the patient’s thighs during the surgery. Were there measures done to ensure that assistants were not leaning against the [candy cane] patients?”

In terms of the 6-week outcome measure, Dr. Kho suggested PROMIS outcomes measured at 2 weeks and at 4 or 6 weeks “would have provided greater insight to the study question.

“The authors acknowledge that neuropathies due to patient positioning manifest soon after surgery and tend to be transient. Incidence of neuropathy is extremely low in both groups and is equivalent. Factors that could impair quick return to normal activity as a result of the neuromuscular effects due to patient positioning should have been measured earlier,” she suggested.

Finally, Dr. Kho noted that the authors “fail to provide any likely rationale for the impaired physical function measured at 6 weeks that can be attributed to the difference in the angles at the femur. The findings of decreased physical function at 6 weeks in the candy cane group may be incidental, and may be different if measured at an earlier time (which would be more pertinent for this study) or at a later time such as 3 months.”

Individual authors acknowledged personal funds from Society of Gynecologic Surgeons, Elsevier publishing, RBI Medical, and AMAG Pharmaceuticals. Dr. Kho had no relevant financial disclosures.

SOURCE: Gupta A et al. Obstet Gynecol. 2020 July 8. doi: 10.1097/AOG.0000000000003954.

Women undergoing vaginal surgery have better physical function after 6 weeks when they are positioned in boot stirrups rather than candy cane stirrups, according to the first randomized controlled trial comparing both types of lithotomy stirrups.

“Participants positioned in candy cane stirrups had greater hip abduction than those positioned in boot stirrups, which could provide a rationale for our findings,” suggested Ankita Gupta, MD, MPH, of the University of Louisville (Ky.), and colleagues. Their report is in Obstetrics & Gynecology.

But one expert questions this interpretation, calling it a major limitation of the study.

“The only difference between the two arms of the study is associated with the angles between the femurs,” said Rosanne M. Kho, MD, a gynecologic surgeon at Cleveland Clinic, who was not involved in the study. “The difference of the angles at the femur is not inherent to the type of stirrup but in the method in which the patients were positioned using the two different types of stirrups,” she said. “The same wide angle between the femurs can be attained with the boot stirrups if the patient is not positioned properly. To determine if the same benefit in physical function is achieved with a lesser angle between the femur, the investigators should use only one type of stirrup (whether the candy cane or the boot stirrups) and change only the angles of the femur.”

The study was a single-masked, randomized controlled trial of women undergoing vaginal surgery at the University of Louisville’s division of urogynecology between March 2018 and Oct. 2019. Surgeries included any combination of vaginal hysterectomy, vaginal vault suspension (uterosacral or sacrospinous ligament fixation), vaginectomy (partial or total), mid-urethral slings, or other surgeries such as urethral diverticulectomy, fistula repair, or mesh excision.

Among the 138 women included in the intention-to-treat analysis, 72 were randomized to candy cane, and 66 to boot (Yellofin) stirrups. They were positioned in the assigned stirrup by the attending surgeon, with assistance from the surgical team, after administration of anesthesia and were not informed of their allocation until the end of the study at 6 weeks post surgery.

On day 1 post surgery, a 100-point visual analog scale (VAS) questionnaire was administered for pain in the lower back, hips, buttocks, thighs, knees, calves, and feet, followed by a series of questionnaires at 6 weeks post surgery, including the PROMIS (Patient-Reported Outcomes Measurement Information System) forms on physical function, pain intensity, and pain interference, as well as the Pelvic Floor Disability Index (PFDI-20) and the Patient Global Impression of Improvement forms.

While the authors acknowledged that neurologic injuries following vaginal surgery are rare, and therefore difficult to measure, physical function is a “prudent” alternative measurement.

Although the study was designed to compare lithotomy stirrups, patient positioning also was measured. Once the patient was anesthetized, the surgeon used a goniometer to measure flexion at the hip and knee joints, the angle of abduction and external rotation at the hip. The “angle between the femurs” was measured by placing the fulcrum of the goniometer at the anal opening.

While the angles of flexion at the hips and knees were similar between groups, the study found a significant difference between groups in the angle between the femurs (mean ± standard deviation, 88.7 ± 13.4 candy cane vs. 77.2 ± 13.3 boot, P < .01).

In addition, the primary outcome, change in physical function based on the PROMIS physical function shortform-20a, was significantly different between the two groups: While subjects in the candy cane group demonstrated a decline of 1.9 in mean physical function score at 6 weeks compared to baseline, those in the boot stirrup group showed an increase of 1.9 from baseline. The mean 6-week postoperative scores were 45.8 versus 49.8 for the candy cane and boot stirrup groups respectively (P < .01).

Although it was “well executed by a well-respected group of vaginal surgeons at a major academic institution,” the study has other limitations, noted Dr. Kho.

“Though the measurements were obtained with the goniometer at the beginning of the surgery, it does not appear that a repeat measurement was performed at the end of the case. Is it possible that positioning could have shifted and resulted in further change in the angle of the femur/hip/knees compared to the beginning of the surgery?” she asked.

In addition, “compared to the candy canes, the boot stirrup has bulky boots that could limit opportunities for bedside assistants who were standing next to the primary surgeon to lean against the patient’s thighs during the surgery. Were there measures done to ensure that assistants were not leaning against the [candy cane] patients?”

In terms of the 6-week outcome measure, Dr. Kho suggested PROMIS outcomes measured at 2 weeks and at 4 or 6 weeks “would have provided greater insight to the study question.

“The authors acknowledge that neuropathies due to patient positioning manifest soon after surgery and tend to be transient. Incidence of neuropathy is extremely low in both groups and is equivalent. Factors that could impair quick return to normal activity as a result of the neuromuscular effects due to patient positioning should have been measured earlier,” she suggested.

Finally, Dr. Kho noted that the authors “fail to provide any likely rationale for the impaired physical function measured at 6 weeks that can be attributed to the difference in the angles at the femur. The findings of decreased physical function at 6 weeks in the candy cane group may be incidental, and may be different if measured at an earlier time (which would be more pertinent for this study) or at a later time such as 3 months.”

Individual authors acknowledged personal funds from Society of Gynecologic Surgeons, Elsevier publishing, RBI Medical, and AMAG Pharmaceuticals. Dr. Kho had no relevant financial disclosures.

SOURCE: Gupta A et al. Obstet Gynecol. 2020 July 8. doi: 10.1097/AOG.0000000000003954.

Polycystic ovarian syndrome (PCOS) was associated with a nearly doubled risk of developing psoriasis in a propensity score–matched analysis conducted in Taiwan.

PCOS is characterized by androgen elevation that can lead to insulin resistance and metabolic syndrome, which have also been associated with an increased risk of psoriasis. Previous retrospective analyses have suggested an increased risk of psoriasis associated with PCOS, and psoriasis patients with PCOS have been reported to have more severe skin lesions, compared with those who do not have PCOS.

“The incidence of psoriasis is indeed higher in the PCOS group than in the control group, and the comorbidities related to metabolic syndrome did not modify the adjusted hazard ratio,” said Ming-Li Chen, during her presentation of the study results at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. Dr. Chen is at Chung Shan Medical University in Taiwan.

The researchers analyzed 1 million randomly selected records from Taiwan’s Longitudinal Health Insurance database, a subset of the country’s National Health Insurance Program. Between 2000 and 2012, they identified a case group with at least three outpatient diagnoses or one inpatient diagnosis of PCOS; they then compared each with four patients who did not have PCOS who were matched by age and index year. The mean age in both groups was about 27 years.

The mean follow-up times were 6.99 years for 4,707 cases and 6.94 years for 18,828 controls. Comorbidities were slightly higher in the PCOS group, including asthma (6.7% vs. 4.9%; P less than .001), chronic obstructive pulmonary disease (14% vs. 11%; P less than .001), chronic liver disease (8.0% vs. 5.0%; P less than .001), diabetes mellitus (3.0% vs. 1.4%; P less than .001), hypertension (2.4% vs. 1.5%; P less than .001), hyperlipidemia (5.4% vs. 2.5%; P less than .001), depression (5.4% vs. 3.9%; P less than .001), and sleep apnea (0.23% vs. 0.10%; P = .040).

There was a higher cumulative incidence of psoriasis in the PCOS group (adjusted hazard ratio, 2.07; 95% confidence interval, 1.25-3.44). Other factors associated with increased risk of psoriasis were advanced age (greater than 50 years old; aHR, 14.13; 95% CI, 1.8-110.7) and having a cancer diagnosis (aHR, 11.72; 95% CI, 2.87-47.9).

When PCOS patients were stratified by age, the researchers noted a higher risk of psoriasis among those 20 years or younger (aHR, 4.02; 95% CI, 1.16-13.9) than among those aged 20-50 years (aHR, 1.88; 95% CI, 1.07-3.29). Among those older than 50 years, there was no significantly increased risk, although the number of psoriasis diagnoses and population sizes were small in the latter category. Among patients with PCOS, a cancer diagnosis was not associated with a statistically significant increased risk of psoriasis.

The mechanisms underlying the association between PCOS and psoriasis should be studied further, she noted.

Following Dr. Chen’s prerecorded presentation, there was a live discussion session led by Alice Gottlieb, MD, PhD, medical director of Mount Sinai Beth Israel Dermatology, New York, and Ennio Lubrano, MD, associate professor of rheumatology at the University of Molise (Italy). Dr. Gottlieb noted that the study did not appear to account for weight in the association between PCOS and psoriasis, since heavier people are known to be at greater risk of developing psoriasis. Dr. Chen acknowledged that the study had no records of BMI or weight.

Dr. Gottlieb also wondered if treatment of PCOS led to any improvements in psoriasis in patients with the two diagnoses. “If we treat PCOS, does the psoriasis get better?” Again, the study did not address the question. “We didn’t follow up on therapies,” Dr. Chen said.

Dr. Chen reported no relevant financial disclosures. Dr. Gottlieb is a consultant, advisory board member and/or speaker for AbbVie, Allergan, Avotres Therapeutics, Beiersdorf, Bristol-Myers Squibb, Celgene, Dermira, Eli Lilly, Incyte, Janssen, Leo, Novartis, Reddy Labs, Sun Pharmaceutical Industries, UCB Pharma and Xbiotech. She has received research or educational grants from Boehringer Ingelheim, Incyte, Janssen, Novartis and Xbiotech.

Polycystic ovarian syndrome (PCOS) was associated with a nearly doubled risk of developing psoriasis in a propensity score–matched analysis conducted in Taiwan.

PCOS is characterized by androgen elevation that can lead to insulin resistance and metabolic syndrome, which have also been associated with an increased risk of psoriasis. Previous retrospective analyses have suggested an increased risk of psoriasis associated with PCOS, and psoriasis patients with PCOS have been reported to have more severe skin lesions, compared with those who do not have PCOS.

“The incidence of psoriasis is indeed higher in the PCOS group than in the control group, and the comorbidities related to metabolic syndrome did not modify the adjusted hazard ratio,” said Ming-Li Chen, during her presentation of the study results at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. Dr. Chen is at Chung Shan Medical University in Taiwan.

The researchers analyzed 1 million randomly selected records from Taiwan’s Longitudinal Health Insurance database, a subset of the country’s National Health Insurance Program. Between 2000 and 2012, they identified a case group with at least three outpatient diagnoses or one inpatient diagnosis of PCOS; they then compared each with four patients who did not have PCOS who were matched by age and index year. The mean age in both groups was about 27 years.

The mean follow-up times were 6.99 years for 4,707 cases and 6.94 years for 18,828 controls. Comorbidities were slightly higher in the PCOS group, including asthma (6.7% vs. 4.9%; P less than .001), chronic obstructive pulmonary disease (14% vs. 11%; P less than .001), chronic liver disease (8.0% vs. 5.0%; P less than .001), diabetes mellitus (3.0% vs. 1.4%; P less than .001), hypertension (2.4% vs. 1.5%; P less than .001), hyperlipidemia (5.4% vs. 2.5%; P less than .001), depression (5.4% vs. 3.9%; P less than .001), and sleep apnea (0.23% vs. 0.10%; P = .040).

There was a higher cumulative incidence of psoriasis in the PCOS group (adjusted hazard ratio, 2.07; 95% confidence interval, 1.25-3.44). Other factors associated with increased risk of psoriasis were advanced age (greater than 50 years old; aHR, 14.13; 95% CI, 1.8-110.7) and having a cancer diagnosis (aHR, 11.72; 95% CI, 2.87-47.9).

When PCOS patients were stratified by age, the researchers noted a higher risk of psoriasis among those 20 years or younger (aHR, 4.02; 95% CI, 1.16-13.9) than among those aged 20-50 years (aHR, 1.88; 95% CI, 1.07-3.29). Among those older than 50 years, there was no significantly increased risk, although the number of psoriasis diagnoses and population sizes were small in the latter category. Among patients with PCOS, a cancer diagnosis was not associated with a statistically significant increased risk of psoriasis.

The mechanisms underlying the association between PCOS and psoriasis should be studied further, she noted.

Following Dr. Chen’s prerecorded presentation, there was a live discussion session led by Alice Gottlieb, MD, PhD, medical director of Mount Sinai Beth Israel Dermatology, New York, and Ennio Lubrano, MD, associate professor of rheumatology at the University of Molise (Italy). Dr. Gottlieb noted that the study did not appear to account for weight in the association between PCOS and psoriasis, since heavier people are known to be at greater risk of developing psoriasis. Dr. Chen acknowledged that the study had no records of BMI or weight.

Dr. Gottlieb also wondered if treatment of PCOS led to any improvements in psoriasis in patients with the two diagnoses. “If we treat PCOS, does the psoriasis get better?” Again, the study did not address the question. “We didn’t follow up on therapies,” Dr. Chen said.

Dr. Chen reported no relevant financial disclosures. Dr. Gottlieb is a consultant, advisory board member and/or speaker for AbbVie, Allergan, Avotres Therapeutics, Beiersdorf, Bristol-Myers Squibb, Celgene, Dermira, Eli Lilly, Incyte, Janssen, Leo, Novartis, Reddy Labs, Sun Pharmaceutical Industries, UCB Pharma and Xbiotech. She has received research or educational grants from Boehringer Ingelheim, Incyte, Janssen, Novartis and Xbiotech.

Polycystic ovarian syndrome (PCOS) was associated with a nearly doubled risk of developing psoriasis in a propensity score–matched analysis conducted in Taiwan.

PCOS is characterized by androgen elevation that can lead to insulin resistance and metabolic syndrome, which have also been associated with an increased risk of psoriasis. Previous retrospective analyses have suggested an increased risk of psoriasis associated with PCOS, and psoriasis patients with PCOS have been reported to have more severe skin lesions, compared with those who do not have PCOS.

“The incidence of psoriasis is indeed higher in the PCOS group than in the control group, and the comorbidities related to metabolic syndrome did not modify the adjusted hazard ratio,” said Ming-Li Chen, during her presentation of the study results at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. Dr. Chen is at Chung Shan Medical University in Taiwan.

The researchers analyzed 1 million randomly selected records from Taiwan’s Longitudinal Health Insurance database, a subset of the country’s National Health Insurance Program. Between 2000 and 2012, they identified a case group with at least three outpatient diagnoses or one inpatient diagnosis of PCOS; they then compared each with four patients who did not have PCOS who were matched by age and index year. The mean age in both groups was about 27 years.

The mean follow-up times were 6.99 years for 4,707 cases and 6.94 years for 18,828 controls. Comorbidities were slightly higher in the PCOS group, including asthma (6.7% vs. 4.9%; P less than .001), chronic obstructive pulmonary disease (14% vs. 11%; P less than .001), chronic liver disease (8.0% vs. 5.0%; P less than .001), diabetes mellitus (3.0% vs. 1.4%; P less than .001), hypertension (2.4% vs. 1.5%; P less than .001), hyperlipidemia (5.4% vs. 2.5%; P less than .001), depression (5.4% vs. 3.9%; P less than .001), and sleep apnea (0.23% vs. 0.10%; P = .040).

There was a higher cumulative incidence of psoriasis in the PCOS group (adjusted hazard ratio, 2.07; 95% confidence interval, 1.25-3.44). Other factors associated with increased risk of psoriasis were advanced age (greater than 50 years old; aHR, 14.13; 95% CI, 1.8-110.7) and having a cancer diagnosis (aHR, 11.72; 95% CI, 2.87-47.9).

When PCOS patients were stratified by age, the researchers noted a higher risk of psoriasis among those 20 years or younger (aHR, 4.02; 95% CI, 1.16-13.9) than among those aged 20-50 years (aHR, 1.88; 95% CI, 1.07-3.29). Among those older than 50 years, there was no significantly increased risk, although the number of psoriasis diagnoses and population sizes were small in the latter category. Among patients with PCOS, a cancer diagnosis was not associated with a statistically significant increased risk of psoriasis.

The mechanisms underlying the association between PCOS and psoriasis should be studied further, she noted.

Following Dr. Chen’s prerecorded presentation, there was a live discussion session led by Alice Gottlieb, MD, PhD, medical director of Mount Sinai Beth Israel Dermatology, New York, and Ennio Lubrano, MD, associate professor of rheumatology at the University of Molise (Italy). Dr. Gottlieb noted that the study did not appear to account for weight in the association between PCOS and psoriasis, since heavier people are known to be at greater risk of developing psoriasis. Dr. Chen acknowledged that the study had no records of BMI or weight.

Dr. Gottlieb also wondered if treatment of PCOS led to any improvements in psoriasis in patients with the two diagnoses. “If we treat PCOS, does the psoriasis get better?” Again, the study did not address the question. “We didn’t follow up on therapies,” Dr. Chen said.

Dr. Chen reported no relevant financial disclosures. Dr. Gottlieb is a consultant, advisory board member and/or speaker for AbbVie, Allergan, Avotres Therapeutics, Beiersdorf, Bristol-Myers Squibb, Celgene, Dermira, Eli Lilly, Incyte, Janssen, Leo, Novartis, Reddy Labs, Sun Pharmaceutical Industries, UCB Pharma and Xbiotech. She has received research or educational grants from Boehringer Ingelheim, Incyte, Janssen, Novartis and Xbiotech.

Women with a high body mass index who request tubal ligation immediately post partum face no increased risk of complications, compared with normal-weight woman, according to a large, single-institution, retrospective study.

“Our study underscores the overall safety of postpartum tubal ligation among overweight and obese women,” John J. Byrne, MD, MPH, and colleagues at the University of Texas, Dallas, reported in Obstetrics & Gynecology.

“Even among women in the highest BMI category, this procedure is safe and effective,” they noted, despite previous studies identifying body mass index (BMI) higher than 40 kg/m² “as a significant barrier to this procedure.”

“For the woman who is appropriately counseled and desires permanent contraception, BMI should not impede her access to the procedure,” Dr. Byrne and associates said.

The study included 3,670 women undergoing postpartum tubal ligation after a vaginal delivery between August 2015 and March 2019 at Parkland Hospital, which is operated by the Dallas County Hospital District.

The method used was the Parkland-type tubal ligation – a bilateral midsegment partial salpingectomy performed through a 2-3 cm infraumbilical incision. Women were excluded if they were planning additional surgery, such as ovarian cyst removal or hernia repair at the same time.

Comparing a composite outcome of surgical complications and subsequent pregnancies over a 5-year follow-up, the study found no differences across all maternal BMI categories, which were stratified as: underweight or normal weight (BMI, 24.9 or lower), overweight (25-29.9), class I obesity (30-34.9), class II obesity (35-39.9), and class III obesity (40 or higher).

A full breakdown of the composite morbidity included “blood transfusion, aborted procedure, intraoperative complications (bleeding requiring additional surgery, extension of incision), anesthetic complication (high spinal, bronchospasm, postdural puncture headaches requiring blood patch, and allergic reaction to anesthetic), postoperative complication (deep wound infection, venous thromboembolism, ileus, small bowel obstruction, acute intestinal herniation, peritonitis), return to operating room, incomplete transection of fallopian tube, and subsequent pregnancy,” they reported.

Among the study subjects, the mean BMI was 32.2, with 263 being underweight or normal weight at the time of admission, 1,044 being overweight, 1,371 having class I obesity, 689 having class II obesity, 303 having class III obesity, and 11 patients classified as supermorbidly obese (a BMI of 50 or higher).

Overall, “composite morbidity occurred in 49 (1.3%) women and was not significantly different across BMI categories (P = .07),” noted the authors.

More specifically, there were 19 (1.5%) composite morbidity events in the nonobese cohort and 30 (1.3%) in the obese cohort. “Even among women who had undergone prior abdominal surgery, there was no association of BMI with the rate of procedural complication,” Dr. Byrne and associates added.

The subsequent pregnancy rate was 1.63 per 1,000 procedures performed, which is “significantly lower than previously reported estimates,” they noted. In total, there were six subsequent pregnancies in the cohort: three full term, two ectopic, and one of unknown location.

“Although there was variability in operative time in all BMI categories, this is likely not clinically relevant as the range in operative time overlapped across groups,” reported the authors. “Other surgical metrics, such as estimated blood loss and length of hospitalization after tubal ligation, were found to be no different between BMI categories.”

Their findings “can be generalized to other tubal ligation forms, such as modified Pomeroy and even possibly salpingectomy, if the minilaparotomy incision is the same,” Dr. Byrne and colleagues suggested.

“This innovative study adds an important practical perspective to the literature on postpartum permanent contraception – a finding that should be reassuring for obstetrician/gynecologists,” commented Eve Espey, MD MPH, who was not involved in the research.

“Women with high BMI are significantly less likely to receive desired postvaginal delivery tubal ligation, compared to lower-BMI women, as documented in several prior studies,” said Dr. Espey, who is professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque.

“Although those studies did not explore the reasons for nonfulfillment, intuitively concerns about complications or inability to complete the procedure are the most likely explanations,” she added.

“Although this study is limited by its retrospective nature, the smaller number of women in the highest BMI category, and lack of information on patients with unfulfilled requests for tubal ligation, it is overall well designed and should serve to encourage physicians to proceed with postvaginal delivery tubal ligation in patients across all BMI categories,” Dr. Espey concluded.

The study received no external funding; Dr. Byrne and associates reported no relevant financial disclosures. Dr. Espey is a member of the Ob.Gyn. News editorial advisory board, and said she has no relevant financial disclosures.

SOURCE: Byrne JJ et al. Obstet Gynecol. 2020;136:342-8.
 

Women with a high body mass index who request tubal ligation immediately post partum face no increased risk of complications, compared with normal-weight woman, according to a large, single-institution, retrospective study.

“Our study underscores the overall safety of postpartum tubal ligation among overweight and obese women,” John J. Byrne, MD, MPH, and colleagues at the University of Texas, Dallas, reported in Obstetrics & Gynecology.

“Even among women in the highest BMI category, this procedure is safe and effective,” they noted, despite previous studies identifying body mass index (BMI) higher than 40 kg/m² “as a significant barrier to this procedure.”

“For the woman who is appropriately counseled and desires permanent contraception, BMI should not impede her access to the procedure,” Dr. Byrne and associates said.

The study included 3,670 women undergoing postpartum tubal ligation after a vaginal delivery between August 2015 and March 2019 at Parkland Hospital, which is operated by the Dallas County Hospital District.

The method used was the Parkland-type tubal ligation – a bilateral midsegment partial salpingectomy performed through a 2-3 cm infraumbilical incision. Women were excluded if they were planning additional surgery, such as ovarian cyst removal or hernia repair at the same time.

Comparing a composite outcome of surgical complications and subsequent pregnancies over a 5-year follow-up, the study found no differences across all maternal BMI categories, which were stratified as: underweight or normal weight (BMI, 24.9 or lower), overweight (25-29.9), class I obesity (30-34.9), class II obesity (35-39.9), and class III obesity (40 or higher).

A full breakdown of the composite morbidity included “blood transfusion, aborted procedure, intraoperative complications (bleeding requiring additional surgery, extension of incision), anesthetic complication (high spinal, bronchospasm, postdural puncture headaches requiring blood patch, and allergic reaction to anesthetic), postoperative complication (deep wound infection, venous thromboembolism, ileus, small bowel obstruction, acute intestinal herniation, peritonitis), return to operating room, incomplete transection of fallopian tube, and subsequent pregnancy,” they reported.

Among the study subjects, the mean BMI was 32.2, with 263 being underweight or normal weight at the time of admission, 1,044 being overweight, 1,371 having class I obesity, 689 having class II obesity, 303 having class III obesity, and 11 patients classified as supermorbidly obese (a BMI of 50 or higher).

Overall, “composite morbidity occurred in 49 (1.3%) women and was not significantly different across BMI categories (P = .07),” noted the authors.

More specifically, there were 19 (1.5%) composite morbidity events in the nonobese cohort and 30 (1.3%) in the obese cohort. “Even among women who had undergone prior abdominal surgery, there was no association of BMI with the rate of procedural complication,” Dr. Byrne and associates added.

The subsequent pregnancy rate was 1.63 per 1,000 procedures performed, which is “significantly lower than previously reported estimates,” they noted. In total, there were six subsequent pregnancies in the cohort: three full term, two ectopic, and one of unknown location.

“Although there was variability in operative time in all BMI categories, this is likely not clinically relevant as the range in operative time overlapped across groups,” reported the authors. “Other surgical metrics, such as estimated blood loss and length of hospitalization after tubal ligation, were found to be no different between BMI categories.”

Their findings “can be generalized to other tubal ligation forms, such as modified Pomeroy and even possibly salpingectomy, if the minilaparotomy incision is the same,” Dr. Byrne and colleagues suggested.

“This innovative study adds an important practical perspective to the literature on postpartum permanent contraception – a finding that should be reassuring for obstetrician/gynecologists,” commented Eve Espey, MD MPH, who was not involved in the research.

“Women with high BMI are significantly less likely to receive desired postvaginal delivery tubal ligation, compared to lower-BMI women, as documented in several prior studies,” said Dr. Espey, who is professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque.

“Although those studies did not explore the reasons for nonfulfillment, intuitively concerns about complications or inability to complete the procedure are the most likely explanations,” she added.

“Although this study is limited by its retrospective nature, the smaller number of women in the highest BMI category, and lack of information on patients with unfulfilled requests for tubal ligation, it is overall well designed and should serve to encourage physicians to proceed with postvaginal delivery tubal ligation in patients across all BMI categories,” Dr. Espey concluded.

The study received no external funding; Dr. Byrne and associates reported no relevant financial disclosures. Dr. Espey is a member of the Ob.Gyn. News editorial advisory board, and said she has no relevant financial disclosures.

SOURCE: Byrne JJ et al. Obstet Gynecol. 2020;136:342-8.
 

Women with a high body mass index who request tubal ligation immediately post partum face no increased risk of complications, compared with normal-weight woman, according to a large, single-institution, retrospective study.

“Our study underscores the overall safety of postpartum tubal ligation among overweight and obese women,” John J. Byrne, MD, MPH, and colleagues at the University of Texas, Dallas, reported in Obstetrics & Gynecology.

“Even among women in the highest BMI category, this procedure is safe and effective,” they noted, despite previous studies identifying body mass index (BMI) higher than 40 kg/m² “as a significant barrier to this procedure.”

“For the woman who is appropriately counseled and desires permanent contraception, BMI should not impede her access to the procedure,” Dr. Byrne and associates said.

The study included 3,670 women undergoing postpartum tubal ligation after a vaginal delivery between August 2015 and March 2019 at Parkland Hospital, which is operated by the Dallas County Hospital District.

The method used was the Parkland-type tubal ligation – a bilateral midsegment partial salpingectomy performed through a 2-3 cm infraumbilical incision. Women were excluded if they were planning additional surgery, such as ovarian cyst removal or hernia repair at the same time.

Comparing a composite outcome of surgical complications and subsequent pregnancies over a 5-year follow-up, the study found no differences across all maternal BMI categories, which were stratified as: underweight or normal weight (BMI, 24.9 or lower), overweight (25-29.9), class I obesity (30-34.9), class II obesity (35-39.9), and class III obesity (40 or higher).

A full breakdown of the composite morbidity included “blood transfusion, aborted procedure, intraoperative complications (bleeding requiring additional surgery, extension of incision), anesthetic complication (high spinal, bronchospasm, postdural puncture headaches requiring blood patch, and allergic reaction to anesthetic), postoperative complication (deep wound infection, venous thromboembolism, ileus, small bowel obstruction, acute intestinal herniation, peritonitis), return to operating room, incomplete transection of fallopian tube, and subsequent pregnancy,” they reported.

Among the study subjects, the mean BMI was 32.2, with 263 being underweight or normal weight at the time of admission, 1,044 being overweight, 1,371 having class I obesity, 689 having class II obesity, 303 having class III obesity, and 11 patients classified as supermorbidly obese (a BMI of 50 or higher).

Overall, “composite morbidity occurred in 49 (1.3%) women and was not significantly different across BMI categories (P = .07),” noted the authors.

More specifically, there were 19 (1.5%) composite morbidity events in the nonobese cohort and 30 (1.3%) in the obese cohort. “Even among women who had undergone prior abdominal surgery, there was no association of BMI with the rate of procedural complication,” Dr. Byrne and associates added.

The subsequent pregnancy rate was 1.63 per 1,000 procedures performed, which is “significantly lower than previously reported estimates,” they noted. In total, there were six subsequent pregnancies in the cohort: three full term, two ectopic, and one of unknown location.

“Although there was variability in operative time in all BMI categories, this is likely not clinically relevant as the range in operative time overlapped across groups,” reported the authors. “Other surgical metrics, such as estimated blood loss and length of hospitalization after tubal ligation, were found to be no different between BMI categories.”

Their findings “can be generalized to other tubal ligation forms, such as modified Pomeroy and even possibly salpingectomy, if the minilaparotomy incision is the same,” Dr. Byrne and colleagues suggested.

“This innovative study adds an important practical perspective to the literature on postpartum permanent contraception – a finding that should be reassuring for obstetrician/gynecologists,” commented Eve Espey, MD MPH, who was not involved in the research.

“Women with high BMI are significantly less likely to receive desired postvaginal delivery tubal ligation, compared to lower-BMI women, as documented in several prior studies,” said Dr. Espey, who is professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque.

“Although those studies did not explore the reasons for nonfulfillment, intuitively concerns about complications or inability to complete the procedure are the most likely explanations,” she added.

“Although this study is limited by its retrospective nature, the smaller number of women in the highest BMI category, and lack of information on patients with unfulfilled requests for tubal ligation, it is overall well designed and should serve to encourage physicians to proceed with postvaginal delivery tubal ligation in patients across all BMI categories,” Dr. Espey concluded.

The study received no external funding; Dr. Byrne and associates reported no relevant financial disclosures. Dr. Espey is a member of the Ob.Gyn. News editorial advisory board, and said she has no relevant financial disclosures.

SOURCE: Byrne JJ et al. Obstet Gynecol. 2020;136:342-8.
 

Improving hand hygiene, optimizing antibiotic order sets, and removing catheters sooner were among the interventions associated with a decreased risk of infections after hysterectomy, according to research presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

rclassenlayouts/Getty Images

“Implementation of bundled interventions and an institutional focus on reducing infection can successfully reduce the burden of posthysterectomy infectious morbidity,” said study author Shitanshu Uppal, MBBS, an ob.gyn. specializing in gynecologic oncology at the University of Michigan in Ann Arbor.

To assess the impact of quality improvement efforts on infectious morbidity after hysterectomy, Dr. Uppal and colleagues analyzed data from 1,867 hysterectomies performed between Oct. 8, 2015, and Oct. 7, 2018. Patients were at least 18 years old, younger than 90 years old, and underwent hysterectomy via any route at the University of Michigan Medical Center Hospital.

Interventions to reduce infections included the use of cefazolin as a preferred antibiotic, the addition of metronidazole to first-generation cephalosporins for antibiotic prophylaxis, subcuticular closure of open incisions, and earlier removal of Foley catheters. In addition, the institution evaluated and shared information about doctors’ hand hygiene, implemented enhanced recovery after surgery (ERAS) protocols, and held periodic meetings with doctors to discuss efforts to reduce infections. Most interventions were implemented by November 2017.

The primary outcome was overall infection rate in the 30 days after surgery for each of the 3 years included the study. Infections included superficial surgical site infections, deep infections, Clostridium difficile infections, and urinary tract infections, among others.

Patients’ baseline clinical characteristics did not differ during the 3 years studied. Length of stay decreased, which may be attributed to increased use of ERAS protocols and institution of same-day discharge in laparoscopic cases, Dr. Uppal said. The rate of malignancy on final pathology decreased from 29% in year 1 to 23% in year 3. The rate of laparoscopic surgery increased from 55% to 64%.

Infectious morbidity rates decreased from 7% in year 1 (47 infections per 644 cases) to 4% in year 3 (22 infections per 616 cases).

“We saw a reduction in infection rate in all categories,” said Dr. Uppal. “However, the reduction in urinary tract infection as well as superficial surgical site infection was most pronounced.”

After adjustment for the route of surgery, body mass index, age, malignancy on final pathology, modality of surgery, and comorbidities, performance of hysterectomy in year 3 was independently predictive of lower rates of infectious morbidity by 56%.

In addition, the standardized incidence ratio for surgical site infection as reported by the Centers for Medicare & Medicaid Services decreased. In December 2016, Michigan Medicine’s ratio was 1.057. At the end of 2018, the projected ratio was 0.243.

The interventions started on different dates, and “we are unable to conclude, from all the implemented interventions, which one worked,” Dr. Uppal noted.

“I hope the elements from this quality improvement initiative will become the standard of care in order to benefit our patients,” said Amy Park, MD, section head of female pelvic medicine and reconstructive surgery at Cleveland Clinic.

[email protected]

SOURCE: Uppal S et al. SGS 2020, Abstract 16.

Improving hand hygiene, optimizing antibiotic order sets, and removing catheters sooner were among the interventions associated with a decreased risk of infections after hysterectomy, according to research presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

rclassenlayouts/Getty Images

“Implementation of bundled interventions and an institutional focus on reducing infection can successfully reduce the burden of posthysterectomy infectious morbidity,” said study author Shitanshu Uppal, MBBS, an ob.gyn. specializing in gynecologic oncology at the University of Michigan in Ann Arbor.

To assess the impact of quality improvement efforts on infectious morbidity after hysterectomy, Dr. Uppal and colleagues analyzed data from 1,867 hysterectomies performed between Oct. 8, 2015, and Oct. 7, 2018. Patients were at least 18 years old, younger than 90 years old, and underwent hysterectomy via any route at the University of Michigan Medical Center Hospital.

Interventions to reduce infections included the use of cefazolin as a preferred antibiotic, the addition of metronidazole to first-generation cephalosporins for antibiotic prophylaxis, subcuticular closure of open incisions, and earlier removal of Foley catheters. In addition, the institution evaluated and shared information about doctors’ hand hygiene, implemented enhanced recovery after surgery (ERAS) protocols, and held periodic meetings with doctors to discuss efforts to reduce infections. Most interventions were implemented by November 2017.

The primary outcome was overall infection rate in the 30 days after surgery for each of the 3 years included the study. Infections included superficial surgical site infections, deep infections, Clostridium difficile infections, and urinary tract infections, among others.

Patients’ baseline clinical characteristics did not differ during the 3 years studied. Length of stay decreased, which may be attributed to increased use of ERAS protocols and institution of same-day discharge in laparoscopic cases, Dr. Uppal said. The rate of malignancy on final pathology decreased from 29% in year 1 to 23% in year 3. The rate of laparoscopic surgery increased from 55% to 64%.

Infectious morbidity rates decreased from 7% in year 1 (47 infections per 644 cases) to 4% in year 3 (22 infections per 616 cases).

“We saw a reduction in infection rate in all categories,” said Dr. Uppal. “However, the reduction in urinary tract infection as well as superficial surgical site infection was most pronounced.”

After adjustment for the route of surgery, body mass index, age, malignancy on final pathology, modality of surgery, and comorbidities, performance of hysterectomy in year 3 was independently predictive of lower rates of infectious morbidity by 56%.

In addition, the standardized incidence ratio for surgical site infection as reported by the Centers for Medicare & Medicaid Services decreased. In December 2016, Michigan Medicine’s ratio was 1.057. At the end of 2018, the projected ratio was 0.243.

The interventions started on different dates, and “we are unable to conclude, from all the implemented interventions, which one worked,” Dr. Uppal noted.

“I hope the elements from this quality improvement initiative will become the standard of care in order to benefit our patients,” said Amy Park, MD, section head of female pelvic medicine and reconstructive surgery at Cleveland Clinic.

[email protected]

SOURCE: Uppal S et al. SGS 2020, Abstract 16.

Improving hand hygiene, optimizing antibiotic order sets, and removing catheters sooner were among the interventions associated with a decreased risk of infections after hysterectomy, according to research presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

rclassenlayouts/Getty Images

“Implementation of bundled interventions and an institutional focus on reducing infection can successfully reduce the burden of posthysterectomy infectious morbidity,” said study author Shitanshu Uppal, MBBS, an ob.gyn. specializing in gynecologic oncology at the University of Michigan in Ann Arbor.

To assess the impact of quality improvement efforts on infectious morbidity after hysterectomy, Dr. Uppal and colleagues analyzed data from 1,867 hysterectomies performed between Oct. 8, 2015, and Oct. 7, 2018. Patients were at least 18 years old, younger than 90 years old, and underwent hysterectomy via any route at the University of Michigan Medical Center Hospital.

Interventions to reduce infections included the use of cefazolin as a preferred antibiotic, the addition of metronidazole to first-generation cephalosporins for antibiotic prophylaxis, subcuticular closure of open incisions, and earlier removal of Foley catheters. In addition, the institution evaluated and shared information about doctors’ hand hygiene, implemented enhanced recovery after surgery (ERAS) protocols, and held periodic meetings with doctors to discuss efforts to reduce infections. Most interventions were implemented by November 2017.

The primary outcome was overall infection rate in the 30 days after surgery for each of the 3 years included the study. Infections included superficial surgical site infections, deep infections, Clostridium difficile infections, and urinary tract infections, among others.

Patients’ baseline clinical characteristics did not differ during the 3 years studied. Length of stay decreased, which may be attributed to increased use of ERAS protocols and institution of same-day discharge in laparoscopic cases, Dr. Uppal said. The rate of malignancy on final pathology decreased from 29% in year 1 to 23% in year 3. The rate of laparoscopic surgery increased from 55% to 64%.

Infectious morbidity rates decreased from 7% in year 1 (47 infections per 644 cases) to 4% in year 3 (22 infections per 616 cases).

“We saw a reduction in infection rate in all categories,” said Dr. Uppal. “However, the reduction in urinary tract infection as well as superficial surgical site infection was most pronounced.”

After adjustment for the route of surgery, body mass index, age, malignancy on final pathology, modality of surgery, and comorbidities, performance of hysterectomy in year 3 was independently predictive of lower rates of infectious morbidity by 56%.

In addition, the standardized incidence ratio for surgical site infection as reported by the Centers for Medicare & Medicaid Services decreased. In December 2016, Michigan Medicine’s ratio was 1.057. At the end of 2018, the projected ratio was 0.243.

The interventions started on different dates, and “we are unable to conclude, from all the implemented interventions, which one worked,” Dr. Uppal noted.

“I hope the elements from this quality improvement initiative will become the standard of care in order to benefit our patients,” said Amy Park, MD, section head of female pelvic medicine and reconstructive surgery at Cleveland Clinic.

[email protected]

SOURCE: Uppal S et al. SGS 2020, Abstract 16.

A study has found that 7 days of treatment with tamoxifen can help treat troublesome bleeding in women who are using an etonogestrel implant for birth control.

“Our data support the use of tamoxifen as an effective option that offers the benefit of a shorter duration of treatment than other approaches such as combined oral contraceptives,” wrote Alison B. Edelman, MD, MPH, of Oregon Health & Science University, Portland, and coauthors. The report is in Obstetrics & Gynecology.

To determine if a short course of tamoxifen – typically used to treat breast cancer – could prove beneficial in reducing bothersome bleeding, the researchers launched a 90-day, double-blind randomized trial of women between the ages of 15 and 45 years who had been using the etonogestrel 68-mg subdermal contraceptive implant for at least 30 days. All participants suffered from frequent or prolonged bleeding or spotting during the previous month; their mean age was 24, and most (n = 62) identified as White.

Of the initial 112 participants, 107 began treatment and were split into two groups: 10 mg of tamoxifen twice a day for 7 days (n = 55) or placebo (n = 52). One hundred and four patients completed treatment one, and 88 completed 90 days. After the first treatment, women in the tamoxifen group experienced 9.8 more consecutive days of amenorrhea (95% confidence interval, 4.6-15.0) compared with the placebo group, as well as more total days of no bleeding in the first 90 days (median 73.5 [24-89] versus 68 [11-81], P = .001).

Afterward, both groups underwent a 90-day, open-label study where all participants took tamoxifen. The differences between the groups mostly disappeared, as they both experienced more amenorrhea days (median 56 [6-81] for tamoxifen and 67.5 [7-83] for placebo) and fewer bleeding days (median 12 [0-63] for tamoxifen and 12 [0-82] for placebo) compared with the placebo group during the initial 90 days. Although no serious adverse events occurred, more women taking tamoxifen reported fluid retention (12 versus 1), headache (19 versus 1), and mood changes (13 versus 2).

“This is a very promising drug for this purpose,” Catherine Cansino, MD, MPH, of the University of California, Davis, said in an interview, adding that it is “a bit unconventional because tamoxifen is traditionally used for cancer or precancer.”

As such, she recognized that young people of reproductive age might be a little wary of the drug. That said, having an effective treatment for troublesome bleeding beyond estrogen-based products should ultimately prove beneficial for clinicians and patients alike.

“Unfortunately, we don’t have long-term data so it’s unclear what the safety outcomes are,” she said, “but having another option to address bothersome bleeding can help women stay on birth control longer. The alternative would be pregnancy, with its own associated risks.”

The authors acknowledged their study’s limitations, including a lack of Black patients and the likelihood that their volunteer cohort “may not reflect the general population of implant users who present for discontinuation owing to bleeding problems.” They also enrolled a small but notable number of women who had been using the implant for less than 3 months, noting that bleeding patterns often change from the first 90 days and so “some of these women would likely experience better (or worse) bleeding irrespective of treatment.”

The study was supported by a Merck Women’s Health Investigator Initiated Studies Program and the Oregon Clinical and Translational Research Institute. Four of the authors acknowledged receiving consulting fees and research support from various organizations and pharmaceutical companies. The remaining three had no relevant financial disclosures. Dr. Cansino is a member of the Ob.Gyn. News editorial advisory board. She said she had no relevant financial disclosures.

SOURCE: Edelman AB et al. Obstet Gynecol. 2020 Jul 9. doi: 10.1097/AOG.0000000000003896.

A study has found that 7 days of treatment with tamoxifen can help treat troublesome bleeding in women who are using an etonogestrel implant for birth control.

“Our data support the use of tamoxifen as an effective option that offers the benefit of a shorter duration of treatment than other approaches such as combined oral contraceptives,” wrote Alison B. Edelman, MD, MPH, of Oregon Health & Science University, Portland, and coauthors. The report is in Obstetrics & Gynecology.

To determine if a short course of tamoxifen – typically used to treat breast cancer – could prove beneficial in reducing bothersome bleeding, the researchers launched a 90-day, double-blind randomized trial of women between the ages of 15 and 45 years who had been using the etonogestrel 68-mg subdermal contraceptive implant for at least 30 days. All participants suffered from frequent or prolonged bleeding or spotting during the previous month; their mean age was 24, and most (n = 62) identified as White.

Of the initial 112 participants, 107 began treatment and were split into two groups: 10 mg of tamoxifen twice a day for 7 days (n = 55) or placebo (n = 52). One hundred and four patients completed treatment one, and 88 completed 90 days. After the first treatment, women in the tamoxifen group experienced 9.8 more consecutive days of amenorrhea (95% confidence interval, 4.6-15.0) compared with the placebo group, as well as more total days of no bleeding in the first 90 days (median 73.5 [24-89] versus 68 [11-81], P = .001).

Afterward, both groups underwent a 90-day, open-label study where all participants took tamoxifen. The differences between the groups mostly disappeared, as they both experienced more amenorrhea days (median 56 [6-81] for tamoxifen and 67.5 [7-83] for placebo) and fewer bleeding days (median 12 [0-63] for tamoxifen and 12 [0-82] for placebo) compared with the placebo group during the initial 90 days. Although no serious adverse events occurred, more women taking tamoxifen reported fluid retention (12 versus 1), headache (19 versus 1), and mood changes (13 versus 2).

“This is a very promising drug for this purpose,” Catherine Cansino, MD, MPH, of the University of California, Davis, said in an interview, adding that it is “a bit unconventional because tamoxifen is traditionally used for cancer or precancer.”

As such, she recognized that young people of reproductive age might be a little wary of the drug. That said, having an effective treatment for troublesome bleeding beyond estrogen-based products should ultimately prove beneficial for clinicians and patients alike.

“Unfortunately, we don’t have long-term data so it’s unclear what the safety outcomes are,” she said, “but having another option to address bothersome bleeding can help women stay on birth control longer. The alternative would be pregnancy, with its own associated risks.”

The authors acknowledged their study’s limitations, including a lack of Black patients and the likelihood that their volunteer cohort “may not reflect the general population of implant users who present for discontinuation owing to bleeding problems.” They also enrolled a small but notable number of women who had been using the implant for less than 3 months, noting that bleeding patterns often change from the first 90 days and so “some of these women would likely experience better (or worse) bleeding irrespective of treatment.”

The study was supported by a Merck Women’s Health Investigator Initiated Studies Program and the Oregon Clinical and Translational Research Institute. Four of the authors acknowledged receiving consulting fees and research support from various organizations and pharmaceutical companies. The remaining three had no relevant financial disclosures. Dr. Cansino is a member of the Ob.Gyn. News editorial advisory board. She said she had no relevant financial disclosures.

SOURCE: Edelman AB et al. Obstet Gynecol. 2020 Jul 9. doi: 10.1097/AOG.0000000000003896.

A study has found that 7 days of treatment with tamoxifen can help treat troublesome bleeding in women who are using an etonogestrel implant for birth control.

“Our data support the use of tamoxifen as an effective option that offers the benefit of a shorter duration of treatment than other approaches such as combined oral contraceptives,” wrote Alison B. Edelman, MD, MPH, of Oregon Health & Science University, Portland, and coauthors. The report is in Obstetrics & Gynecology.

To determine if a short course of tamoxifen – typically used to treat breast cancer – could prove beneficial in reducing bothersome bleeding, the researchers launched a 90-day, double-blind randomized trial of women between the ages of 15 and 45 years who had been using the etonogestrel 68-mg subdermal contraceptive implant for at least 30 days. All participants suffered from frequent or prolonged bleeding or spotting during the previous month; their mean age was 24, and most (n = 62) identified as White.

Of the initial 112 participants, 107 began treatment and were split into two groups: 10 mg of tamoxifen twice a day for 7 days (n = 55) or placebo (n = 52). One hundred and four patients completed treatment one, and 88 completed 90 days. After the first treatment, women in the tamoxifen group experienced 9.8 more consecutive days of amenorrhea (95% confidence interval, 4.6-15.0) compared with the placebo group, as well as more total days of no bleeding in the first 90 days (median 73.5 [24-89] versus 68 [11-81], P = .001).

Afterward, both groups underwent a 90-day, open-label study where all participants took tamoxifen. The differences between the groups mostly disappeared, as they both experienced more amenorrhea days (median 56 [6-81] for tamoxifen and 67.5 [7-83] for placebo) and fewer bleeding days (median 12 [0-63] for tamoxifen and 12 [0-82] for placebo) compared with the placebo group during the initial 90 days. Although no serious adverse events occurred, more women taking tamoxifen reported fluid retention (12 versus 1), headache (19 versus 1), and mood changes (13 versus 2).

“This is a very promising drug for this purpose,” Catherine Cansino, MD, MPH, of the University of California, Davis, said in an interview, adding that it is “a bit unconventional because tamoxifen is traditionally used for cancer or precancer.”

As such, she recognized that young people of reproductive age might be a little wary of the drug. That said, having an effective treatment for troublesome bleeding beyond estrogen-based products should ultimately prove beneficial for clinicians and patients alike.

“Unfortunately, we don’t have long-term data so it’s unclear what the safety outcomes are,” she said, “but having another option to address bothersome bleeding can help women stay on birth control longer. The alternative would be pregnancy, with its own associated risks.”

The authors acknowledged their study’s limitations, including a lack of Black patients and the likelihood that their volunteer cohort “may not reflect the general population of implant users who present for discontinuation owing to bleeding problems.” They also enrolled a small but notable number of women who had been using the implant for less than 3 months, noting that bleeding patterns often change from the first 90 days and so “some of these women would likely experience better (or worse) bleeding irrespective of treatment.”

The study was supported by a Merck Women’s Health Investigator Initiated Studies Program and the Oregon Clinical and Translational Research Institute. Four of the authors acknowledged receiving consulting fees and research support from various organizations and pharmaceutical companies. The remaining three had no relevant financial disclosures. Dr. Cansino is a member of the Ob.Gyn. News editorial advisory board. She said she had no relevant financial disclosures.

SOURCE: Edelman AB et al. Obstet Gynecol. 2020 Jul 9. doi: 10.1097/AOG.0000000000003896.