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.
Abstract
Uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) are
commonly performed pelvic organ prolapse procedures despite a lack of long-term efficacy
data.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.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.Two randomizations: (1) BPMT (n = 186) or usual care (n = 188)
and (2) surgical intervention (ULS: n = 188 or SSLF: n = 186).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).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]).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.clinicaltrials.gov Identifier: NCT01166373.
Type
Journal articlePermalink
https://hdl.handle.net/10161/16621Published Version (Please cite this version)
10.1001/jama.2018.2827Publication Info
Jelovsek, J Eric; Barber, Matthew D; Brubaker, Linda; Norton, Peggy; Gantz, Marie;
Richter, Holly E; ... NICHD Pelvic Floor Disorders Network (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.
JAMA, 319(15). 10.1001/jama.2018.2827. Retrieved from https://hdl.handle.net/10161/16621.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
Collections
More Info
Show full item recordScholars@Duke
Matthew Don Barber
W. Allen Addison, M.D. Distinguished Professor of Obstetrics and Gynecology
John E Jelovsek
F. Bayard Carter Distinguished Professor of Obstetrics and Gynecology
Dr. Jelovsek is the F. Bayard Carter Distinguished Professor of OBGYN at Duke University
and serves as Director of Data Science for Women’s Health. He is Board Certified in
OBGYN by the American Board of OBGYN and in Female Pelvic Medicine & Reconstructive
Surgery by the American Board of OBGYN and American Board of Urology. He has an active
surgical practice in urogynecology based out of Duke Raleigh. He has expertise as
a clinician-scientist in developing and evaluating clini
Alison Catherine Weidner
Professor of Obstetrics and Gynecology
I am an active clinician/researcher treating women with various forms of pelvic floor
dysfunction throughout my career. I maintain a busy clinical practice and particularly
enjoy and excel at clinical and surgical training of Iearners at all levels in the
medical setting. Early in my career I designed and executed innovative clinical research
with broad-reaching impact on our knowledge of the mechanism of neuromuscular injury
to the pelvic floor and its ultimate contribution to
Alphabetical list of authors with Scholars@Duke profiles.

Articles written by Duke faculty are made available through the campus open access policy. For more information see: Duke Open Access Policy
Rights for Collection: Scholarly Articles
Works are deposited here by their authors, and represent their research and opinions, not that of Duke University. Some materials and descriptions may include offensive content. More info