Prolapse, SUI treatments found largely equivalent

For women undergoing surgery for vaginal prolapse and stress urinary incontinence, neither sacrospinous ligament fixation (SSLF) nor uterosacral ligament vaginal vault suspension (ULS) was superior to the other for functional or adverse event outcomes, according to a recent study.

In addition, perioperative behavioral therapy with pelvic floor muscle training (BPMT) did not improve urinary symptoms or prolapse outcomes after surgery, the study’s authors reported in JAMA (2014; 311:1023-34).

In the OPTIMAL (Operations and Pelvic Muscle Training in the Management of Apical Support Loss) trial, randomized 374 women undergoing surgery to treat both apical vaginal prolapse and stress urinary incontinence at nine U.S. medical centers to SSLF (n=186) or ULS (n=188), and to receive BPMT (n=186) or usual care (n=188).

The authors, led by first author Matthew D. Barber, MD, MHS, of Cleveland Clinic, found that in the 84.5% of participants followed up at 2 years, the proportion of patients who had successful surgery (defined as a composite of anatomic results, patient-reported symptoms, and retreatment) was not different between groups: 59.2% for ULS versus 60.5% for SSLF. In addition, serious adverse event proportions were comparable (ULS, 16.5% vs. SSLF, 16.7%).

BPMT around the time of surgery was not associated with greater improvements in incontinence measures at 6 months, prolapse symptom scores at 24 months, or measures of anatomic success (as defined by certain criteria) at 24 months.

The authors write that their study provides evidence for patients and their surgeons about the benefits, risks, and complications of these two surgical procedures, as well as the role of BPMT.

“Although our results do not support routinely offering perioperative BPMT to women undergoing vaginal surgery for prolapse and stress urinary incontinence, previous evidence supports offering individualized treatment, including behavioral or physical therapy, to those who report new or unresolved pelvic floor symptoms,” the authors wrote.

“Little has been known until now about how these procedures compare to each other,” said co-author Linda Brubaker, MD, MS, of Loyola University Chicago Stritch School of Medicine, Chicago. “This study provides guidance to physicians on the benefits and risks of two widely used surgical interventions without vaginal prolapse mesh."

They add that although variability in surgical recommendations for vaginal prolapse repair is likely to persist because of individual patient characteristics, their data provide a metric against which other vaginal procedures can be assessed.

A number of study co-authors reported being consultants for Pfizer, Astellas, GlaxoSmithKline, Uromedica, IDEO, Xanodyne, Renew Medical, American Medical Systems, and Ferring Pharmaceuticals.

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