Clinical Trial: Randomized Clinical Trial of Burch vs Sling Procedures for Women with Stress Urinary Incontinence

This study is no longer recruiting patients.

Sponsors and Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Alabama, 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)

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

MedlinePlus related topics:  Urinary Incontinence

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Official Title: Randomized Clinical Trial of the Burch Modified Tanagho and Autologous Fascia Sling Procedures for Women with Predominantly Stress Urinary Incontinence

Further Study Details: 

Expected Total Enrollment:  650

Study start: February 2002;  Study completion: January 2006

Eligibility

Ages Eligible for Study:  21 Years and above,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

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.

Location Information


Alabama
      University of Alabama, Birmingham,  Alabama,  35249-7333,  United States

California
      University of California, San Diego,  California,  92037,  United States

Illinois
      Loyola University Medical Center, Maywood,  Illinois,  60153,  United States

Maryland
      University of Maryland, Baltimore,  Maryland,  21201,  United States

Michigan
      Beaumont Hospital, Royal Oak,  Michigan,  48073,  United States

Pennsylvania
      University of Pittsburgh, Pittsburgh,  Pennsylvania,  15213,  United States

Texas
      University of Texas, Southwestern, Dallas,  Texas,  75390-9110,  United States

      University of Texas Health Sciences Center, San Antonio,  Texas,  78229-3900,  United States

Utah
      University of Utah, Salt Lake City,  Utah,  84132,  United States

Study chairs or principal investigators

William D. Steers, M.D.,  Study Chair,  University of Virginia   

More Information

www.uitn.net

Study ID Numbers:  UITN-RCT
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  July 10, 2003
ClinicalTrials.gov Identifier:  NCT00064662
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005