Behavior Enhances Drug Reduction of Incontinence (BE-DRI) - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 27, 2004

Last Updated Date

December 21, 2007

Start Date ^†

August 2004

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00090584 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Behavior Enhances Drug Reduction of Incontinence (BE-DRI)

Official Title ^†

Behavior Enhances Drug Reduction of Incontinence

Brief Summary

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.

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Urinary Incontinence

Intervention ^†

Drug: Tolterodine
Behavioral: Combination Drug (tolterodine) and Behavior Treatment

Study Arms / Comparison Groups

Publications *

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.

* 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 ^†

Completed

Enrollment ^†

300

Completion Date

June 2006

Primary Completion Date

Eligibility 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

Gender

Female

Ages

21 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00090584

Responsible Party

Debuene Chang, MD Project Officer, NIDDK

Secondary IDs ^††

Study Sponsor ^†

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

Collaborators ^††

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

Investigators ^†

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

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.