At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 322 enrolled

Drug / intervention

Burch urethropexy at time of sacrocolpopexyprocedure

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/NCT00065845

NCT00065845Phase 3Completed

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CARE: A Randomized Trial of Colpopexy and Urinary Reduction Efforts

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·interventional·Posted Aug 5, 2003·Updated Jan 11, 2011

In Brief

A Phase 3 clinical trial evaluating Burch urethropexy at time of sacrocolpopexy for Urinary Incontinence, Stress and 2 related conditions. Completed, enrolled 322 participants across 7 sites.

Detailed Summary

Pelvic organ prolapse occurs when the muscles holding pelvic organs (e.g., the uterus or bladder) weaken and the organs fall or slide down into the vagina. Pelvic organ prolapse can be corrected with surgery. However, women who have this surgery may develop urinary incontinence. This study will determine how doctors can predict this problem and whether an additional surgical procedure at the time of prolapse surgery can prevent the development of urinary incontinence.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsUrinary Incontinence, Stress, Uterine Prolapse, Vaginal Prolapse

CountriesUnited States

Collaborators--

Timeline

Phase 3CompletedFinished

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartApr 2002

First PostedAug 2003

Primary CompletionMar 2007

Study CompletionApr 2007

TodayJul 2026

First PostedAug 5, 2003

Enrollment StartApr 1, 2002

Primary CompletionMar 1, 2007

Study CompletionApr 1, 2007

TodayJul 2, 2026

Enrollment to primary: 4.9 yearsPosted 22.9 years ago

Interventions

Burch urethropexy at time of sacrocolpopexyprocedure

The Burch colposuspension procedure entails the retropubic placement of at least two stitches in the vaginal tissue lateral to each side of the urethra, and suspension of these stitches from Cooper's ligament (the iliopectineal line at the superior aspect of the posterior pubic bone).