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

May 8, 2013 updated by: HealthCore-NERI

Behavior Enhances Drug Reduction of Incontinence

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

307

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama
    • California
      • San Diego, California, United States, 92103
        • University of California
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
    • Michigan
      • Royal Oak, Michigan, United States, 48123
        • Oakwood Hospital and Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Sciences Center
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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, Multiple Sclerosis, spinal cord injury)
  • History of extensive behavior treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination therapy
Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication (tolterodine) and behavioral training.
Drug: Tolterodine
4mg/d for 10 weeks. Could be reduced to 2mg/d for managing side effects.
Behavioral: Behavioral training
Training in pelvic floor muscle control and exercises; behavioral strategies to diminish urgency, suppress bladder contractions and prevent incontinence; delayed voiding; and individualized fluid management.
Active Comparator: Drug therapy alone
Women assigned to this arm received 10 weeks of anti-cholinergic medication (tolterodine), only.
Drug: Tolterodine
4mg/d for 10 weeks. Could be reduced to 2mg/d for managing side effects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Women Who Meet Definition of Success
Time Frame: 8 months
Proportion of women who meet definition of success: not taking drug or receiving other urge UI therapy (i.e., neuromodulation, botox injections, myomectomy, electrical stimulation, or any intravesical therapy) and not taking a tricyclic antidepressant or duloxetine at 8 months; and a >70% reduction in number of incontinence episodes as compared to baseline.
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Incontinence Episodes
Time Frame: Baseline and 10 weeks
Change from baseline to 10 weeks in number of incontinence episodes per week as reported on bladder diary.
Baseline and 10 weeks
Change in Voids Per Day
Time Frame: baseline and 10 weeks
Change from baseline to 10 weeks in frequency of voids per day as reported on bladder diary
baseline and 10 weeks
Symptom Distress
Time Frame: baseline, 10 weeks and 8 months
Urogenital distress inventory (UDI). Higher score indicates greater distress. Possible range 0 to 300.
baseline, 10 weeks and 8 months
Symptom Bother
Time Frame: baseline, 10 weeks and 8 months
Disease specific overactive bladder scale (OAB-q). HIgher score indicates greater bother. Possible range 0 to 100.
baseline, 10 weeks and 8 months
Satisfaction
Time Frame: 10 weeks
Number of women who responded "completely satisfied" to question, "How satisfied are you with your progress?"
10 weeks
Satisfaction
Time Frame: 8 months
Number of women who responded "completely satisfied" to question "How satisfied are you with your progress?"
8 months
Symptom Improvement
Time Frame: 10 weeks
Number of women who responded "much better" or "better" to question: "Overall, do you feel that you are much better, better, about the same, worse or much worse?"
10 weeks
Symptom Improvement
Time Frame: 8 months
Number of women who responded "much better" or "better" to question: "Overall, do you feel that you are much better, better, about the same, worse or much worse?"
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthCore-NERI

Collaborators

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

Investigators

  • Study Chair: William D Steers, M.D., University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

August 27, 2004

First Submitted That Met QC Criteria

August 30, 2004

First Posted (Estimate)

August 31, 2004

Study Record Updates

Last Update Posted (Estimate)

June 17, 2013

Last Update Submitted That Met QC Criteria

May 8, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BE-DRI (completed)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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