Behavior Enhances Drug Reduction of Incontinence (BE-DRI)

Not Applicable

Completed

• Conditions: Urinary Incontinence (UI)
• Interventions: Drug: Tolterodine; Behavioral: Behavioral training

• Registration Number: NCT00090584
• Lead Sponsor: Carelon Research

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

Not available

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2004-08-27
• Study First Submitted QC: 2004-08-30
• Study First Posted: 2004-08-31
• Primary Completion: 2005-12
• Study Completion: 2006-08
• Results First Submitted: 2012-08-27
• Status Verified: 2013-05
• Results First Submitted QC: 2013-05-08
• Last Update Submitted: 2013-05-08
• Results First Posted: 2013-06-17
• Last Update Posted: 2013-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 307

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination therapy	Tolterodine	Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication (tolterodine) and behavioral training.
Combination therapy	Behavioral training	Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication (tolterodine) and behavioral training.
Drug therapy alone	Tolterodine	Women assigned to this arm received 10 weeks of anti-cholinergic medication (tolterodine), only.

Primary Outcome Measures

Name	Time	Method
Proportion of Women Who Meet Definition of Success	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.

Secondary Outcome Measures

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

Trial Locations

Locations (9)

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Oakwood Hospital and Medical Center; 🇺🇸 Royal Oak, Michigan, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Texas Southwestern; 🇺🇸 Dallas, Texas, United States

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

University of California; 🇺🇸 San Diego, California, United States

University of Texas Health Sciences Center; 🇺🇸 San Antonio, Texas, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States