Pelvic organ prolapse (protrusion) occurs when the uterus descends into the lower vagina or vaginal walls protrude beyond the vaginal opening, and can occur as a result of childbirth. Approximately 300,000 surgeries for prolapse are performed annually in the United States; the two most widely used vaginal procedures for correcting apical (upper vaginal) prolapse are sacrospinous ligament fixation (SSLF) and the uterosacral ligament vaginal vault suspension (ULS). To date, no comparative data exist about their relative efficacy and safety, according to background information in the article.
A majority of women seeking vaginal prolapse surgery report urinary incontinence, including the common subtype of stress incontinence or involuntary urine loss with coughing, sneezing, or physical activity. Behavioral therapy with pelvic floor (the area underneath the pelvis composed of muscle fibers and soft tissue) muscle training (BPMT) is an effective stand-alone therapy for incontinence.
Matthew D. Barber, M.D., M.H.S., of the Cleveland Clinic, and colleagues 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 researchers found that in the 84.5 percent of participants followed up at two 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: (ULS, 59.2 percent vs SSLF, 60.5 percent). In addition, serious adverse event proportions were comparable (ULS, 16.5 percent vs SSLF, 16.7 percent). 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."
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.