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...
Date First Received: August 27, 2004
Last Updated: December 21, 2007
Verified by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), December 2007
Clinical Trial Phase: Phase 2/Phase 3 | Start Date: August 2004
Overall Status: Completed
Estimated Enrollment: 300
Brief Summary
Official Title: “Behavior Enhances Drug Reduction of Incontinence”
Condition Keyword(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Tolterodine
- Behavioral: Combination Drug (tolterodine) and Behavior Treatment
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 21 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Overall Clinical Trial Officials and Contacts
William D Steers, M.D. Study Chair University of Virginia
Additional Information
Information obtained from ClinicalTrials.gov on November 18, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00090584
Study ID Number: BE-DRI
ClinicalTrials.gov Identifier: NCT00090584
Health Authority: United States: Federal Government
Clinical Trials Authorship and Review
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