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Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial

NCT00597935 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 374

Last updated 2020-10-22

Study results available
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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.

Conditions

  • Pelvic Organ Prolapse (POP)

Interventions

PROCEDURE

SSLF

sacrospinous ligament fixation (SSLF)

PROCEDURE

ULS

uterosacral vaginal vault ligament suspension (ULS)

BEHAVIORAL

PMT

Pelvic muscle training and exercises (PMT)

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • NICHD Pelvic Floor Disorders Network

    lead NETWORK

Principal Investigators

  • Matthew Barber, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00597935 on ClinicalTrials.gov