At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 655 enrolled

Drug / intervention

Burch Modified Tanagho +1 moreprocedure

Likely dose

Not stated in record

Key inclusion· 6

✓Predominant stress urinary incontinence confirmed by self-report, examination, and testing
✓Documented urethral hypermobility
✓Eligible for both surgical procedures (Burch and autologous fascia sling)
✓Ambulatory status

Key exclusion· 5

✕Systemic disease known to affect bladder function
✕Current chemotherapy or radiation therapy
✕History of urethral diverticulum, augmentation cytoplasty, or artificial sphincter
✕Recent pelvic surgery

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

Search/NCT00064662

NCT00064662Phase 3Completed

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Randomized Clinical Trial of the Burch Modified Tanagho and Autologous Fascia Sling Procedures for Women With Predominantly Stress Urinary Incontinence

Carelon Research·interventional·Posted Jul 11, 2003·Updated May 10, 2013

In Brief

A Phase 3 clinical trial evaluating Burch Modified Tanagho and Autologous Fascia Sling for Urinary Incontinence. Completed, enrolled 655 participants across 9 sites.

Detailed Summary

The primary aim of this clinical trial is to compare the treatment success for two surgical procedures that are frequently used and have similar cure rates, yet have not been compared directly to each other in a large, rigorously conducted randomized trial. The secondary aims of the trial are to compare other outcomes for the two surgical procedures, including quality of life, sexual function, satisfaction with treatment outcomes, complications, and need for other treatment(s)after surgery. Follow-up will be a minimum of two years and up to four years.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsUrinary Incontinence

CountriesUnited States

CollaboratorsUniversity of Alabama at Birmingham, University of California, San Diego, University of Maryland, University of Pittsburgh, University of Texas, The University of Texas at San Antonio, University of Utah, Beaumont Hospital, Loyola University

Timeline

Phase 3CompletedFinished

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartFeb 2002

First PostedJul 2003

Primary CompletionJun 2006

Study CompletionMar 2010

TodayJul 2026

First PostedJul 11, 2003

Enrollment StartFeb 1, 2002

Primary CompletionJun 1, 2006

Study CompletionMar 1, 2010

TodayJul 2, 2026

Enrollment to primary: 4.3 yearsPosted 23.0 years ago

Interventions

Burch Modified Tanaghoprocedure

The Burch colposuspension is a well-established procedure for surgically treating women with stress urinary incontinence. The Burch modified colposuspension suspends the anterior vaginal wall (at the level of the bladder neck) with permanent sutures tied to the iliopectineal ligament.

Autologous Fascia Slingprocedure

The fascial sling is also a well-established procedure for surgically treating women with stress urinary incontinence. The autologous sling procedure places a harvested strip of rectus fascia transvaginally at the level of the proximal urethra. The fascial strip is secured superiorly to the rectus fascia with permanent sutures