CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 374 enrolled
Drug / intervention
SSLF +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00597935
NCT00597935N/ACompleted

Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial: A Randomized Trial of Sacrospinous Ligament Fixation (SSLF) Versus Uterosacral Ligament Suspension (ULS) With and Without Perioperative Behavioral Therapy/Pelvic Muscle Training

NICHD Pelvic Floor Disorders Network·interventional·Posted Jan 18, 2008·Updated Oct 22, 2020

In Brief

A clinical study evaluating SSLF, ULS, and 1 other intervention for Pelvic Organ Prolapse (POP). Completed, enrolled 374 participants across 9 sites.

Detailed Summary

Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Pelvic organ prolapse often involves a combination of support defects involving the anterior, posterior and/or apical vaginal segments. While the anterior vaginal wall is the segment most likely to demonstrate recurrent prolapse after reconstructive surgery, reoperations are highest among those who require apical suspension procedures with or without repair of other vaginal segments (12%-33%). Despite the substantial health impact, there is a paucity of high quality evidence to support different practices in the management of prolapse, particularly surgery. Thus, the objectives of the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) Trial are: 1. to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault ligament suspension (ULS); and 2. to assess the role of perioperative behavioral therapy/pelvic muscle training (PMT) in women undergoing vaginal surgery for apical or uterine prolapse and stress urinary incontinence.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 18, 2008
Enrollment StartFeb 1, 2008
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 18.5 years ago

Interventions

SSLFprocedure

sacrospinous ligament fixation (SSLF)

ULSprocedure

uterosacral vaginal vault ligament suspension (ULS)

PMTbehavioral

Pelvic muscle training and exercises (PMT)