Behavior Enhances Drug Reduction of Incontinence (BE-DRI)

This study has been completed.

First Received: August 27, 2004 Last Updated: December 21, 2007 History of Changes

Sponsors and Collaborators:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00090584

Purpose

The primary aim of this study is to test if the addition of behavioral treatment to drug therapy for the treatment of urge incontinence will increase the number of patients who can discontinue drug therapy and sustain a significant reduction of incontinence.

Condition	Intervention	Phase
Urinary Incontinence	Drug: Tolterodine Behavioral: Combination Drug (tolterodine) and Behavior Treatment	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Behavior Enhances Drug Reduction of Incontinence

Resource links provided by NLM:

MedlinePlus related topics: Urinary Incontinence

Drug Information available for: Tolterodine Tolterodine tartrate

U.S. FDA Resources

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

Estimated Enrollment:	300
Study Start Date:	August 2004
Estimated Study Completion Date:	June 2006

Eligibility

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

Criteria

Inclusion:

Female
Urge predominant incontinence
Incontinent > 3 mos
Available for 8 mos of followup

Exclusion:

Pregnancy or < 6 mos post-partum
Hypersensitivity to drug (tolterodine)
Systemic disease that affects bladder function (e.g., Parkinson's disease, MS, spinal cord injury)
History of extensive behavior treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090584

Locations

United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35233
United States, California
University of California
San Diego, California, United States, 92103
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
Oakwood Hospital and Medical Center
Royal Oak, Michigan, United States, 48123
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
University of Texas Health Sciences Center
San Antonio, Texas, United States, 78229
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)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Study Chair:

William D Steers, M.D.

University of Virginia

More Information

Additional Information:

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

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Burgio KL, Kraus SR, Menefee S, Borello-France D, Corton M, Johnson HW, Mallett V, Norton P, FitzGerald MP, Dandreo KJ, Richter HE, Rozanski T, Albo M, Zyczynski HM, Lemack GE, Chai TC, Khandwala S, Baker J, Brubaker L, Stoddard AM, Goode PS, Nielsen-Omeis B, Nager CW, Kenton K, Tennstedt SL, Kusek JW, Chang TD, Nyberg LM, Steers W; Urinary Incontinence Treatment Network. Behavioral therapy to enable women with urge incontinence to discontinue drug treatment: a randomized trial. Ann Intern Med. 2008 Aug 5;149(3):161-9.

Responsible Party:	NIDDK ( Debuene Chang, MD Project Officer )
Study ID Numbers:	BE-DRI
Study First Received:	August 27, 2004
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00090584 History of Changes
Health Authority:	United States: Federal Government

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

Urge urinary incontinence
Drug/Behavior treatment

Study placed in the following topic categories:

Muscarinic Antagonists
Signs and Symptoms
Neurotransmitter Agents
Cholinergic Antagonists
Urologic Diseases

Urination Disorders
Urinary Incontinence
Cholinergic Agents
Urinary Incontinence, Urge
Tolterodine

Additional relevant MeSH terms:

Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Urination Disorders
Physiological Effects of Drugs
Cholinergic Agents
Pharmacologic Actions

Muscarinic Antagonists
Urological Manifestations
Signs and Symptoms
Urologic Diseases
Urinary Incontinence
Tolterodine

ClinicalTrials.gov processed this record on July 06, 2009