Randomized Clinical Trial of Burch vs Sling Procedures for Women With Stress Urinary Incontinence - Tabular View

Tracking Information

First Received Date ^ICMJE

July 10, 2003

Last Updated Date

December 21, 2007

Start Date ^ICMJE

February 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00064662 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Urinary Incontinence

Intervention ^ICMJE

Procedure: Burch Modified Tanagho
Procedure: Autologous Fascia Sling

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

650

Completion Date

January 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

21 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00064662

Responsible Party

Debuene Chang, MD, NIDDK

Study ID Numbers ^ICMJE

UITN-RCT

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

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 ^ICMJE

Study Chair:

William D. Steers, M.D.

University of Virginia

Information Provided By

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

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP