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

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

This study has been completed.

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
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

MedlinePlus related topics:

Pelvic Support Problems Stress Urinary Incontinence

U.S. FDA Resources

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

Estimated Enrollment:	650
Study Start Date:	February 2002
Estimated Study Completion Date:	January 2006

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

More Information

www.uitn.net This link exits the ClinicalTrials.gov site

Publications indexed to this study:

Albo ME, Richter HE, Brubaker L, Norton P, Kraus SR, Zimmern PE, Chai TC, Zyczynski H, Diokno AC, Tennstedt S, Nager C, Lloyd LK, FitzGerald M, Lemack GE, Johnson HW, Leng W, Mallett V, Stoddard AM, Menefee S, Varner RE, Kenton K, Moalli P, Sirls L, Dandreo KJ, Kusek JW, Nyberg LM, Steers W; Urinary Incontinence Treatment Network. Burch colposuspension versus fascial sling to reduce urinary stress incontinence. N Engl J Med. 2007 May 24;356(21):2143-55. Epub 2007 May 21.

Responsible Party:	NIDDK ( Debuene Chang, MD )
Study ID Numbers:	UITN-RCT
First Received:	July 10, 2003
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00064662
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Stress urinary incontinence

Surgery

Study placed in the following topic categories:

Signs and Symptoms

Urinary Incontinence, Stress

Urologic Diseases

Urination Disorders

Stress

Urinary Incontinence

Additional relevant MeSH terms:

Urological Manifestations

ClinicalTrials.gov processed this record on October 17, 2008