Presentations at AUGS/IUGA 2019 Scientific Meeting Focus on Sexual Function for Women with Pelvic Floor Disorders

Sexual function after pelvic floor surgery was a hot topic at the AUGS/IUGA 2019 Scientific Meeting. The featured Ulf Ulmsten Memorial Lecture focused on the subject, and there were multiple abstract presentations, including sexual function results of Boston Scientific’s three-year 522 study.

Ulf Ulmsten Memorial Lecture

The Ulf Ulmsten Memorial Lecture featured sexual function pioneer Rebecca Rogers, MD, of the University of Texas at Austin Dell Medical School. Rogers is known for having created and validated the PISQ (Pelvic Organ Prolapse–Urinary Incontinence Sexual Function Questionnaire) – the only condition-specific measure of sexual function for women with pelvic floor dysfunction.

Rogers discussed “Curing Pelvic Floor Disorders in 2040: Measuring Sex and Other Aspects of Pelvic Floor Function.” In her lecture, she challenged providers to focus less on measuring anatomy and highlighted the need to find out what truly matters to patients. She also pointed out that the standard assessment of sexual function – two finger breadths – is not enough.

“We are still focusing on anatomy,” she said. “It’s what we do. We are surgeons. But we need to look beyond that. Although we’ve come a long way, we still have a long way to go in how we measure outcomes in patients. We’re speaking a different language than our patients, and we need to learn the language they’re speaking.”

522 Study Secondary Results: Sexual Function

Assessment of sexual function was a planned secondary objective of Boston Scientific’s 522 prospective study comparing the Solyx™ Single Incision Sling (SIS) System to the gold-standard transobturator mid-urethral sling (TMUS).

The per protocol analysis, presented at the 2018 AUGS annual meeting in Chicago, showed the SIS system achieved treatment success, meeting all primary and secondary endpoints in a three-year study of 281 women with stress urinary incontinence (SUI). The trial also demonstrated that the SIS System was non-inferior to the TMUS procedure for long-term successful treatment of these patients.

The secondary analysis compared sexual function up to 36 months postoperatively. The study found patients had significant improvement in sexual function with either SIS and TMUS, and improvements persisted through the study. De novo sexual pain was rare following both sling surgeries.

“Previously we found that the Solyx Single Incision Sling was non-inferior to the transobturator mid-urethral sling with about 90.4 percent efficacy and a low rate of adverse events,” said Amanda B. White, MD, principal investigator, University of Texas Dell Medical School. “With regard to sexual function, we found that it improves after single incision sling surgery, and it’s equivalent to the improvement we see after surgery with transobturator mid-urethral slings.”

Study Design

Patient-reported outcomes of sexual function were assessed at baseline and 6, 12, 18, 24 and 36 months using the PISQ-12. Changes in sexual function were analyzed within and between groups.

Results

Baseline patient characteristics were balanced using propensity score stratification. There was a significant increase in the mean PISQ-12 score from baseline to 36 months for patients undergoing surgery with SIS and TMUS, indicating better sexual function at each follow-up visit. There were no significant differences seen in PISQ-12 scores between SIS and TMUS except at 36 months, where the difference was not clinically important. De novo dyspareunia was rare following both treatments, occurring in one SIS patient.

With these two analyses of the 522 studies, SIS demonstrated comparable outcomes to TMUS, showing its high efficacy, patient quality of life benefits and improvement in sexual function over the course of three years.

Pelvic Impact Sexual Questionnaire (PISQ-12)
*Statistically significant at 0.05 level

Pelvic Impact Sexual Questionnaire (PISQ-12)

  Treatment Propensity Adjusted Treatment Difference
Study Visit SIS TMUS Estimate [95% CI] p-value
Baseline

33.3 ± 7.1(113)

(13.0,35.0,47.0)

33.7 ± 6.5(103)

(15.0,35.0,45.0)

-0.9

[-3.0 , 1.3]

0.425
6 months

38.9 ± 4.7(97)

(22.0,40.0,46.0)

39.4 ± 4.8(93)

(25.0,40.0,47.0)

-0.5

[-2.2 , 1.3]

0.603
12 months

39.0 ± 4.6(88)

(25.0,40.0,46.0)

39.8 ± 5.2(90)

(16.0,41.0,48.0)

-0.9

[-2.8 , 0.9]

0.318
18 months

38.5 ± 5.6(87)

15.0,39.0,46.0)

40.4 ± 5.3(90)

(25.0,42.0,47.0)

-1.7

[-3.7 , 0.3]

0.093
24 months

38.5 ± 4.8(79)

(24.0,40.0,46.0)

39.6 ± 5.3(82)

(24.0,41.0,48.0)

-0.9

[-3.1 , 1.3]

0.421
36 months

37.9 ± 5.6(80)

(22.0,39.0,45.0)

40.1 ± 5.2(77)

(18.0,41.0,48.0)

-2.5

[-4.7 , -0.2]

0.031
† PISQ-12 has a range from 0-48 with higher scores indicating better sexual function.
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