Comparison of Surgical Procedures to Reduce Urinary Stress Incontinence

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.

Conditions

• Urinary Incontinence

Interventions

PROCEDURE

Burch Modified Tanagho

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.

PROCEDURE

Autologous Fascia Sling

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

Sponsors & Collaborators

• University of Alabama at Birmingham

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• University of Maryland

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• University of Texas

  collaborator OTHER

• The University of Texas at San Antonio

  collaborator OTHER

• University of Utah

  collaborator OTHER

• Beaumont Hospital

  collaborator OTHER

• Loyola University

  collaborator OTHER

• Carelon Research

  lead OTHER

Principal Investigators

• William D. Steers, M.D. · University of Virginia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2002-02-28

Primary Completion

2006-06-30

Completion

2010-03-31

Countries

• United States

Study Locations