OPTIMAL Trial Finds Comparable Outcomes for Two Vaginal Prolapse Surgical Repairs

No benefit found for behavioral therapy or pelvic floor training

By Matthew Barber, MD, MHS

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Vaginal prolapse and resultant stress urinary incontinence are a common post-childbirth complication, with approximately 300,000 prolapse surgeries performed annually in the United States.

Sacrospinous ligament fixation (SSLF) and uterosacral ligament vaginal vault suspension (ULS) are the two most frequently used procedures to correct apical vaginal prolapse. However, there have been no rigorous attempts to compare their relative efficacy and safety. Neither has there been an effort to determine whether perioperative behavioral therapy with pelvic floor muscle training (BPMT) — an effective stand-alone therapy for incontinence — improves the outcomes of prolapse surgery.

A multicenter trial known as OPTIMAL, for Operations and Pelvic Muscle Training in the Management of Apical Support Loss, sought to compare two-year outcomes of patients who underwent SSLF or ULS surgery for apical or uterine prolapse and stress urinary incontinence.

The OPTIMAL trial, conducted at Cleveland Clinic and eight other U.S. medical centers between 2008 and 2013, also evaluated whether perioperative BPMT affected urinary symptoms six months after surgery, and whether it affected anatomic outcomes and prolapse symptoms 24 months after surgery.

OPTIMAL’s findings were that neither repair procedure was superior to the other for functional or adverse event outcomes. Also, the trial determined BPMT did not improve incontinence symptoms or prolapse outcomes.

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Defining successful outcomes

OPTIMAL enrolled women 18 and older with complaints of vaginal bulge and stress urinary incontinence and undergoing surgery for stage 2 through 4 prolapse. Participants were randomly assigned to SSLF or ULS surgery, and to perioperative BPMT or usual care. BPMT involved pelvic floor muscle exercise training and behavioral strategies to reduce urinary and colorectal symptoms.

A “successful” surgical outcome was defined as the absence of:

  • Protrusion of more than one-third of the vaginal apex into the vaginal canal
  • Descent of the anterior or posterior vaginal wall beyond the hymen
  • Bothersome vaginal bulge symptoms
  • Surgical or pessary retreatment for prolapse

Success or failure of the BPMT intervention was determined by patients’ self-reported urinary and prolapse symptoms, and by continuing anatomic failure or retreatment for prolapse.

No difference in surgical outcomes

The OPTIMAL trial found that, in the 84.5 percent of participants who underwent follow-up evaluation at two years, the proportion of patients with successful outcomes was not statistically significantly different between the two surgical procedures (ULS 59.2 percent versus 60.5 percent for SSLF).

Women in the two groups had comparable proportions of severe adverse events during the two-year postoperative evaluation period (ULS 16.5 percent versus 16.7 percent for SSLF). The most common perioperative event was bladder perforation associated with placement of tension-free vaginal tape for the retropubic midurethral sling. Less than 5 percent of the adverse events were directly related to the prolapse surgery.

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BPMT patients fared the same as those who got the usual perioperative care in terms of incontinence measures at six months and prolapse symptom scores and anatomic criteria at 24 months.

No specific BPMT recommendation

The OPTIMAL trial results do not support routine recommendation of perioperative BPMT for women undergoing surgery for vaginal prolapse and stress urinary incontinence. However, existing evidence supports individualized behavioral or physical incontinence therapy for women who are experiencing new or unresolved pelvic floor symptoms.

OPTIMAL’s findings regarding the comparable efficacy and safety of ULS and SSLF are beneficial for preoperative decision-making, particularly in evaluating a patient’s preference for anatomic and subjective outcomes, as well as the likelihood and range of adverse events.

Individual patient characteristics will continue to dictate some variability in the choice of surgical repair technique for vaginal prolapse. But the OPTIMAL results provide a benchmark to assess other vaginal procedures, including those using synthetic or biologic mesh.

Dr. Barber, the OPTIMAL study’s lead author, is Vice Chairman of Clinical Research at Cleveland Clinic’s Ob/Gyn & Women’s Health Institute.