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Behavior Enhances Drug Reduction of Incontinence (BE-DRI)

NCT00090584 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 307

Last updated 2013-06-17

Study results available
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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.

Conditions

  • Urinary Incontinence (UI)

Interventions

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.

Sponsors & Collaborators

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

    collaborator NIH

  • Carelon Research

    lead OTHER

Principal Investigators

  • William D Steers, M.D. · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2005-12-31
Completion
2006-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00090584 on ClinicalTrials.gov