Effect of Uterosacral Ligament Suspension vs Sacrospinous Ligament Fixation With or Without Perioperative Behavioral Therapy for Pelvic Organ Vaginal Prolapse on Surgical Outcomes and Prolapse Symptoms at 5 Years in the OPTIMAL Randomized Clinical Trial | Surgery | JAMA | JAMA Network
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Original Investigation
April 17, 2018

Effect of Uterosacral Ligament Suspension vs Sacrospinous Ligament Fixation With or Without Perioperative Behavioral Therapy for Pelvic Organ Vaginal Prolapse on Surgical Outcomes and Prolapse Symptoms at 5 Years in the OPTIMAL Randomized Clinical 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
  • 3Associate Editor, JAMA
  • 4Department of Obstetrics and Gynecology, University of Utah, Medical Center, Salt Lake City
  • 5RTI International, Research Triangle Park, North Carolina
  • 6Department of Obstetrics and Gynecology, University of Alabama at Birmingham
  • 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 Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas
  • 10Northwest Physician Group, Amarillo, Texas
JAMA. 2018;319(15):1554-1565. doi:10.1001/jama.2018.2827
Key Points

Question  What are the 5-year outcomes associated with uterosacral ligament suspension or sacrospinous ligament fixation with perioperative behavioral therapy and pelvic floor muscle training compared with usual care for women undergoing vaginal prolapse surgery?

Findings  The estimated probability of surgical failure was 61.5% with uterosacral ligament suspension vs 70.3% with sacrospinous ligament fixation, a nonsignificant difference. Anatomic failure was 48% with perioperative behavioral therapy and pelvic floor muscle training and 49.5% with usual care, while Prolapse Organ Prolapse Distress Inventory scores improved by −59.4 points vs −61.8 points, respectively, signifying nonsignificant differences.

Meaning  Vaginal surgery for prolapse failure rates are high despite maintenance of improved prolapse symptoms.

Abstract

Importance  Uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) are commonly performed pelvic organ prolapse procedures despite a lack of long-term efficacy data.

Objective  To compare outcomes in women randomized to (1) ULS or SSLF and (2) usual care or perioperative behavioral therapy and pelvic floor muscle training (BPMT) for vaginal apical prolapse.

Design, Setting, and Participants  This 2 × 2 factorial randomized clinical trial was conducted at 9 US medical centers. Eligible participants who completed the Operations and Pelvic Muscle Training in the Management of Apical Support Loss Trial enrolled between January 2008 and March 2011 and were followed up 5 years after their index surgery from April 2011 through June 2016.

Interventions  Two randomizations: (1) BPMT (n = 186) or usual care (n = 188) and (2) surgical intervention (ULS: n = 188 or SSLF: n = 186).

Main Outcomes and Measures  The primary surgical outcome was time to surgical failure. Surgical failure was defined as (1) apical descent greater than one-third of total vaginal length or anterior or posterior vaginal wall beyond the hymen or retreatment for prolapse (anatomic failure), or (2) bothersome bulge symptoms. The primary behavioral outcomes were time to anatomic failure and Pelvic Organ Prolapse Distress Inventory scores (range, 0-300).

Results  The original study randomized 374 patients, of whom 309 were eligible for this extended trial. For this study, 285 enrolled (mean age, 57.2 years), of whom 244 (86%) completed the extended trial. By year 5, the estimated surgical failure rate was 61.5% in the ULS group and 70.3% in the SSLF group (adjusted difference, −8.8% [95% CI, −24.2 to 6.6]). The estimated anatomic failure rate was 45.6% in the BPMT group and 47.2% in the usual care group (adjusted difference, −1.6% [95% CI, −21.2 to 17.9]). Improvements in Pelvic Organ Prolapse Distress Inventory scores were −59.4 in the BPMT group and −61.8 in the usual care group (adjusted mean difference, 2.4 [95% CI, −13.7 to 18.4]).

Conclusions and Relevance  Among women who had undergone vaginal surgery for apical pelvic organ vaginal prolapse, there was no significant difference between ULS and SSLF in rates of surgical failure and no significant difference between perioperative behavioral muscle training and usual care on rates of anatomic success and symptom scores at 5 years. Compared with outcomes at 2 years, rates of surgical failure increased during the follow-up period, although prolapse symptom scores remained improved.

Trial Registration  clinicaltrials.gov Identifier: NCT01166373

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