ABSTRACT & COMMENTARY
The OPTIMAL Trial: SSLF and ULS for Apical Vaginal Prolapse
By Chiara Ghetti, MD
Associate Professor, Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Washington University School of Medicine, St. Louis, MO
Dr. Ghetti reports no financial relationships relevant to this field of study.
Two years after vaginal surgery for prolapse and stress urinary incontinence, uterosacral ligament suspension and sacrospinous ligament fixation had similar outcomes. Perioperative pelvic floor muscle training did not improve urinary symptoms or prolapse symptoms.
Barber MD, et al; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: The OPTIMAL randomized trial. JAMA 2014;311:1023-1034.
The objective of this study was to evaluate two primary aims in women undergoing surgery for prolapse and stress urinary incontinence: 1) compare 24-month surgical outcomes of sacrospinous ligament fixation (SSLF) and uterosacral ligament suspension (ULS) for apical vaginal or uterine prolapse; and 2) evaluate the effect of perioperative behavioral therapy with pelvic floor muscle training (BPMT) on urinary symptoms at 6 months and on anatomic outcomes prolapse symptoms 24 months after surgery. This was a randomized trial comparing two operations for both apical vaginal prolapse and stress urinary incontinence that was conducted at nine sites between January 2008 and May 2013. Women were randomized to surgical procedure and then randomized to BPMT. The primary outcome for the prolapse surgical intervention was a composite outcome of surgical success. This was defined by three measures: 1) anatomic success: no apical descent greater than one-third into vaginal canalor anterior or posterior vaginal wall beyond the hymen; 2) no bothersome vaginal bulge symptoms; and 3) no re-treatment for prolapse at 2 years. The primary outcomes for the physical therapy intervention were as follows:
1) at 6 months, urinary symptom scores using the Urinary Distress Inventory; and 2) at 24 months, both prolapse symptom scores measured by the Pelvic Organ Prolapse Distress Inventory and anatomic success, as defined previously. Differences between the surgical groups in the primary outcome of surgical success at 24 months and other categorical outcomes were evaluated using generalized linear models. A priori power calculation was performed.
The study enrolled 418 eligible women, and 408 women underwent the behavioral therapy randomization preoperatively. Of these, 374 women were randomized to both the surgical intervention (188 for ULS, 186 for SSLF) and behavioral intervention (186 for BPMT, 188 for usual care) and were included in the analysis. Women in the surgical and the behavioral intervention groups had similar clinical characteristics, with the exception of a greater degree of posterior vaginal prolapse in the SSLF group and a higher median number of vaginal deliveries in the ULS group. There were no differences in surgical interventions between the BPMT and usual care groups. A TVT was performed in 99% of the study population.
At 2 years, there was no statistically significant difference in surgical success between the surgical groups (ULS 59.2% [93/157] vs SSLF 60.5% [92/152]) and no clinically significant differences in any of the four primary outcome components. There was a low rate of adverse events that was not significantly different between groups. Overall, 18.0% of women (55/305) developed bothersome vaginal bulge symptoms, 17.5% (54/308) had anterior or posterior prolapse or both beyond the hymen, and 5.1% (16/316) underwent either conservative or surgical retreatment by 2 years. Recurrent prolapse was more likely to occur in the anterior compartment. The proportion of women with recurrent anterior (ULS 15.5% vs SSLF 13.7%) or posterior prolapse (ULS 4.5% vs SSLF 7.2%) beyond the hymen was not significantly different between treatment groups. Surgical groups were not significantly different for most secondary outcome measures. There were no significant differences between BPMT and usual perioperative care in the 6-month and 24-month primary and secondary outcomes.
Commentary
Pelvic organ prolapse and urinary incontinence are prevalent conditions that often coexist. Pelvic organ prolapse occurs when the uterus and/or vagina descend and may protrude from the vaginal opening. Studies indicate women have an 11% risk of prolapse and incontinence surgery over their lifetime. In the United States, approximately 300,000 surgeries are performed annually for prolapse. The majority are performed vaginally.1-4 Two main vaginal procedures are widely used in the correction of apical prolapse — the sacrospinous ligament fixation and the uterosacral ligament vaginal vault suspension. The SSLF procedure attaches the vaginal apex to the sacrospinous ligament using an extraperitoneal approach. The ULS uses an intraperitoneal approach to bilaterally attach the vaginal apex to the proximal uterosacral ligaments. Comparative data regarding the relative efficacy and safety of these two procedures did not exist prior to this study.
BPMT has been shown to be an effective treatment for pelvic floor symptoms, with incontinence cure rates as high as 78% and improved prolapse stage in up to 17%.5 Its possible role as perioperative adjunct therapy had not been previously explored.
This randomized study provides robust evidence of the benefits, risks, and complications of two very commonly used vaginal surgeries for the repair of apical prolapse. By using standardized anatomic and functional outcomes, this study provides important information for both patients and providers and can help inform our preoperative counseling.
This study found that in women with apical vaginal prolapse and stress urinary incontinence, surgical outcomes for two common apical transvaginal prolapse repair procedures were not different. Surgical success was defined as a composite definition that included anatomic findings, patient-reported symptoms, as well as retreatment. This study found success rates of 60%, which were notably lower than the success rates reported in the literature for these procedures, which range from 70-90%. Are we truly surprised that USL and SSLF are not different? What is remarkable to me is that two commonly performed vaginal procedures for apical prolapse are only successful 60% of the time and that only a small portion of women chose retreatment. Compared to sacrospinous ligament fixation, the abdominal sacrocolpopexy appears to be associated with less recurrent prolapse and less dyspareunia.6 Most women I counsel about having surgery for prolapse want to have surgery once and cringe when I tell them known success rates for vaginal procedures. We are in great need for the development of safe, effective, and durable vaginal procedures for the repair of vaginal apical prolapse.
References
- U.S. Food and Drug Administration. Available at: www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm262299.htm. Accessed Nov. 10, 2014.
- Brown JS, et al. Am J Obstet Gynecol 2002;186:712-716.
- Olsen AL, et al. Obstet Gynecol 1997;89:501-506.
- Boyles SH, et al. Am J Obstet Gynecol 2003;188:108-115.
- Dumoulin C, Hay-Smith J. Cochrane Database Syst Rev 2010;(1):CD005654.
- Maher C, et al. Cochrane Database Syst Rev 2010;4:CD004014.
