TY - JOUR
T1 - 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
AU - Jelovsek, J. Eric
AU - Barber, Matthew D.
AU - Norton, Peggy
AU - Brubaker, Linda
AU - Gantz, Marie
AU - Richter, Holly E.
AU - Weidner, Alison
AU - Menefee, Shawn
AU - Schaffer, Joseph
AU - Pugh, Norma
AU - Meikle, Susan
N1 - Funding Information:
completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Jelovsek reported receiving grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Pelvic Floor Disorders Network and royalties from UpToDate. Dr Barber reported receiving royalties from UptoDate and Elsevier. Dr Brubaker reported receiving grants and other funding from the National Institutes of Health (NIH), JAMA, Journal of Female Pelvic Medicine and Reconstructive Surgery, UpToDate, and the American Board of Obstetrics and Gynecology. Dr Gantz reported receiving grants from the NICHD. Dr Richter reported receiving grants from the NICHD, NIH/Washington University, PCORI/Brown University, UT Southwestern, and Renovia and royalties from UpToDate. Dr Richter was previously on an advisory board for Kimberly-Clark. Dr Weidner reported receiving a grant from the NIH. Dr Menefee reported receiving grants from the NICHD and personal fees from UpToDate. Dr Schaffer reported receiving grants from the NIH and personal fees from Astellas, Boston Scientific, and McGraw-Hill Publishing.
Funding Information:
Funding/Support: This study was supported by grants U01 HD041249, U10 HD041250, U10 HD041261, U10 HD041267, U10 HD054136, U10 HD054214, U10 HD054215, U01 HD069031, and U10 HD054241 from the NICHD and the NIH Office of Research on Women’s Health.
Publisher Copyright:
© 2018 American Medical Association. All rights reserved.
PY - 2018/4/17
Y1 - 2018/4/17
N2 - 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.
AB - 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.
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U2 - 10.1001/jama.2018.2827
DO - 10.1001/jama.2018.2827
M3 - Article
C2 - 29677302
AN - SCOPUS:85046101220
SN - 0098-7484
VL - 319
SP - 1554
EP - 1565
JO - JAMA - Journal of the American Medical Association
JF - JAMA - Journal of the American Medical Association
IS - 15
ER -