UITN (SISTEr) Urinary Incontinence

This study has been completed.

First Received on July 10, 2003. Last Updated on April 25, 2011 History of Changes

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators:	University of Alabama at Birmingham University of California, San Diego University of Maryland University of Pittsburgh University of Texas University of Utah Beaumont Hospital Loyola University New England Research Institutes
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00064662

Purpose

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.

Condition	Intervention	Phase
Urinary Incontinence	Procedure: Burch Modified Tanagho Procedure: Autologous Fascia Sling	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Clinical Trial of the Burch Modified Tanagho and Autologous Fascia Sling Procedures for Women With Predominantly Stress Urinary Incontinence

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

urinary leakage and retreatment for stress urinary incontinence [ Time Frame: Four years ] [ Designated as safety issue: No ]
Urinary leakage and retreatment for stress urinary incontinence

Enrollment:	655
Study Start Date:	February 2002
Study Completion Date:	March 2010
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Burch The Burch colposuspension	Procedure: Burch Modified Tanagho Placement of two stitches on each side where the urethra comes out of the bladder and is attached to pelvic support tissue to help strengthen the support.
Sling Pubovaginal sling, using autologous rectus fascia	Procedure: Autologous Fascia Sling Sling procedure involves placement of the abdominal wall fascia beneath where the urethra comes out of the bladder and attached to the patient's abdominal wall support tissue.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Predominant stress urinary incontinence by self-report,examination and test;
Urethral hypermobility;
Eligible for both surgical procedures;
Ambulatory;
Not pregnant;
>12 months post-partum;
No systemic disease known to affect bladder function;
No current chemotherapy or radiation therapy;
No urethral diverticulum, augmentation cytoplasty, or artificial sphincter;
No recent pelvic surgery;
Available for follow-up and able to complete study assessments;
Signed informed consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064662

Locations

United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35249-7333
United States, California
University of California
San Diego, California, United States, 92037
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Michigan
Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas, Southwestern
Dallas, Texas, United States, 75390-9110
University of Texas Health Sciences Center
San Antonio, Texas, United States, 78229-3900
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

University of Alabama at Birmingham

University of California, San Diego

University of Maryland

University of Pittsburgh

University of Texas

University of Utah

Beaumont Hospital

Loyola University

New England Research Institutes

Investigators

Study Chair:

William D. Steers, M.D.

University of Virginia

Responsible Party:	John W. Kusek, PhD, NIDDK
ClinicalTrials.gov Identifier:	NCT00064662 History of Changes
Other Study ID Numbers:	UITN-RCT (completed)
Study First Received:	July 10, 2003
Last Updated:	April 25, 2011
Health Authority:	United States: Federal Government