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Original Investigation
March 12, 2014

Comparison of 2 Transvaginal Surgical Approaches and Perioperative Behavioral Therapy for Apical Vaginal Prolapse: The OPTIMAL Randomized Trial

Author Affiliations
  • 1Obstetrics/Gynecology and Women’s Health Institute, Cleveland Clinic, Cleveland, Ohio
  • 2Departments of Obstetrics and Gynecology and Urology, Loyola University Chicago Stritch School of Medicine, Chicago, Illinois
  • 3Division of Gerontology, Geriatrics, and Palliative Care, University of Alabama at Birmingham
  • 4Department of Veterans Affairs, Birmingham, Alabama
  • 5Department of Obstetrics and Gynecology, University of Alabama at Birmingham
  • 6Department of Obstetrics and Gynecology, University of Utah, Medical Center, Salt Lake City
  • 7Department of Obstetrics and Gynecology, Duke University, Medical Center, Durham, North Carolina
  • 8Department of Obstetrics and Gynecology, Southern California Kaiser Permanente, San Diego
  • 9Department of Reproductive Medicine, University of California San Diego Health Systems
  • 10Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas
  • 11Department of Obstetrics and Gynecology, Southern California Kaiser Permanente, Downey
  • 12Department of Physical Therapy, Duquesne University, Pittsburgh, Pennsylvania
  • 13Department of Biostatistics, University of Michigan, Ann Arbor
  • 14Social, Statistical, and Environmental Sciences, RTI International, Research Triangle Park, North Carolina
  • 15Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland
JAMA. 2014;311(10):1023-1034. doi:10.1001/jama.2014.1719

Importance  More than 300 000 surgeries are performed annually in the United States for pelvic organ prolapse. Sacrospinous ligament fixation (SSLF) and uterosacral ligament suspension (ULS) are commonly performed transvaginal surgeries to correct apical prolapse. Little is known about their comparative efficacy and safety, and it is unknown whether perioperative behavioral therapy with pelvic floor muscle training (BPMT) improves outcomes of prolapse surgery.

Objective  To compare outcomes between (1) SSLF and ULS and (2) perioperative BPMT and usual care in women undergoing surgery for vaginal prolapse and stress urinary incontinence.

Design, Setting, and Participants  Multicenter, 2 × 2 factorial, randomized trial of 374 women undergoing surgery to treat both apical vaginal prolapse and stress urinary incontinence was conducted between 2008 and 2013 at 9 US medical centers. Two-year follow-up rate was 84.5%.

Interventions  The surgical intervention was transvaginal surgery including midurethral sling with randomization to SSLF (n = 186) or ULS (n = 188); the behavioral intervention was randomization to receive perioperative BPMT (n = 186) or usual care (n = 188).

Main Outcomes and Measures  The primary outcome for the surgical intervention (surgical success) was defined as (1) no apical descent greater than one-third into vaginal canal or anterior or posterior vaginal wall beyond the hymen (anatomic success), (2) no bothersome vaginal bulge symptoms, and (3) no re-treatment for prolapse at 2 years. For the behavioral intervention, primary outcome at 6 months was urinary symptom scores (Urinary Distress Inventory; range 0-300, higher scores worse), and primary outcomes at 2 years were prolapse symptom scores (Pelvic Organ Prolapse Distress Inventory; range 0-300, higher scores worse) and anatomic success.

Results  At 2 years, surgical group was not significantly associated with surgical success rates (ULS, 64.5% [100/155] vs SSLF, 63.1% [94/149]; unadjusted difference, 1.4%; 95% CI, −9.4% to 12.2%; adjusted odds ratio [OR], 1.1; 95% CI, 0.7 to 1.7) or serious adverse event rates (ULS, 16.5% [31/188] vs SSLF, 16.7% [31/186]; unadjusted difference, −0.2%; 95% CI, −7.7% to 7.4%; adjusted OR, 0.9; 95% CI, 0.5 to 1.6). Perioperative BPMT was not associated with greater improvements in urinary scores at 6 months (adjusted treatment difference, −6.7; 95% CI, −19.7 to 6.2), prolapse scores at 24 months (adjusted treatment difference, −8.0; 95% CI, −22.1 to 6.1), or anatomic success at 24 months.

Conclusions and Relevance  Two years after vaginal surgery for prolapse and stress urinary incontinence, neither ULS nor SSLF was significantly superior to the other for anatomic, functional, or adverse event outcomes. Perioperative BPMT did not improve urinary symptoms at 6 months or prolapse outcomes at 2 years.

Trial Registration  clinicaltrials.gov Identifier: NCT00597935