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

Barber, Matthew D.; Brubaker, Linda; Burgio, Kathryn L.; Richter, Holly E.; Nygaard, Ingrid; Weidner, Alison C.; Menefee, Shawn A.; Lukacz, Emily S.; Norton, Peggy; Schaffer, Joseph; Nguyen, John N.; Borello-France, Diane; Goode, Patricia S.; Jakus-Waldman, Sharon; Spino, Cathie; Warren, Lauren Klein; Gantz, Marie G.; Meikle, Susan F.; for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network

Obstetrical & Gynecological Survey:
doi: 10.1097/OGX.0000000000000079
Gynecology: Urogynecology
Abstract

ABSTRACT: Surgical correction of pelvic organ prolapse (POP) is a common procedure performed in the United States. The 2 most widely used vaginal procedures for correction of POP in women with stress urinary incontinence (SUI) are sacrospinous ligament fixation (SSLF) and uterosacral ligament suspension (ULS). No comparative studies have examined the efficacy and safety of these 2 procedures. Behavioral therapy with pelvic floor muscle training (BPMT) is an effective stand-alone therapy for pelvic floor symptoms in women with SUI and may be a logical adjunct to surgery. However, it is unknown whether preoperative BPMT improves prolapse outcomes after surgery.

The OPTIMAL study was a multicenter, 2 × 2 factorial, randomized trial designed to compare surgical outcomes of SSLF and ULS after vaginal surgery in women with prolapse and SUI. The trial also compared the effect of perioperative BPMT and usual care on surgical outcomes in this patient population. Women were treated at 9 US medical centers between 2008 and 2013. The 2-year follow-up rate was 84.5%. Women undergoing surgery for POP and SUI underwent 2 randomizations, the first to perioperative BPMT (n = 186) or usual care (n = 188), and the second to SSLF (n = 186) or ULS (n = 188). Participants were masked to their surgical group assignment, and study surgeons were masked to the physical therapy group assignment. The primary surgical outcome was success at 2 years defined as the following: (1) no apical descent more than one-third into vaginal canal or anterior or posterior vaginal wall decent beyond the hymen (anatomic success), (2) no bothersome vaginal bulge symptoms, and (3) no retreatment for prolapse. Primary outcomes for BPMT were evaluated at 6 and 24 months. The primary behavioral outcome at 6 months, urinary symptom scores, was assessed using Urinary Distress Inventory (range, 0–300, higher scores indicate worse condition). The primary 24-month outcome, prolapse symptom scores, was assessed using the Pelvic Organ Prolapse Distress Inventory (range, 0–300) and anatomic success.

At 2 years, there was no significant difference between the 2 groups in surgical success rates (ULS, 59.2% [93/157] vs SSLF, 60.5% [92/152]); the unadjusted difference was −1.3%, with a 95% confidence interval (CI) of −12.2% to 9.6%, and an adjusted odds ratio of 0.9, with a 95% Cl of 0.6 to 1.5. There was also no difference between groups in 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%] and adjusted odds ratio 0.9 [95% CI, 0.5–1.6]). With respect to behavioral intervention, perioperative BPMT did not produce greater improvements either in urinary scores at 6 months (adjusted treatment difference, −6.7; 95%CI, −19.7 to 6.2), or prolapse scores at 24 months (adjusted treatment difference, −8.0; 95%CI, −22.1 to 6.1), or anatomic success at 24 months.

These data show that there was no significant difference between ULS and SSLF for anatomic, functional, or adverse event outcomes 2 years after vaginal surgery in women with prolapse and SUI. Moreover, the finding that perioperative BPMT did not improve urinary symptoms or prolapse outcomes suggests that this behavioral intervention is unnecessary for routine care in most women undergoing such surgery.

Author Information

Obstetrics/Gynecology and Women’s Health Institute, Cleveland Clinic, Cleveland, OH (M.D.B.); Departments of Obstetrics and Gynecology and Urology, Loyola University Chicago Stritch School of Medicine, Chicago, IL (L.B.); Division of Gerontology, Geriatrics, and Palliative Care (K.L.B., P.S.G.) and Department of Obstetrics and Gynecology (H.E.R.), University of Alabama at Birmingham; Department of Veterans Affairs, Birmingham, AL (K.L.B., P.S.G.); Department of Obstetrics and Gynecology, University of Utah, Medical Center, Salt Lake City, UT (I.N., P.N.); Department of Obstetrics and Gynecology, Duke University, Medical Center, Durham, NC (A.C.W.); Department of Obstetrics and Gynecology, Southern California Kaiser Permanente (S.A.M.); Department of Reproductive Medicine, University of California San Diego Health Systems, San Diego, CA (E.S.L.); Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX (J.S.); Department of Obstetrics and Gynecology, Southern California Kaiser Permanente, Downey, CA (J.N.N., S.J.-W.); Department of Physical Therapy, Duquesne University, Pittsburgh, PA (D.B.-F.); Department of Biostatistics, University of Michigan, Ann Arbor, MI (C.S.); Social, Statistical, and Environmental Sciences, RTI International, Research Triangle Park, NC (L.K.W., M.G.G.); and Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (S.F.M.)

© 2014 by Lippincott Williams & Wilkins.