Behavior Enhances Drug Reduction of Incontinence (BE-DRI) (BE-DRI)
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|ClinicalTrials.gov Identifier: NCT00090584|
Recruitment Status : Completed
First Posted : August 31, 2004
Results First Posted : June 17, 2013
Last Update Posted : June 17, 2013
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence (UI)||Drug: Tolterodine Behavioral: Behavioral training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||307 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Behavior Enhances Drug Reduction of Incontinence|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||December 2005|
|Actual Study Completion Date :||August 2006|
Experimental: Combination therapy
Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication (tolterodine) and behavioral training.
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.
4mg/d for 10 weeks. Could be reduced to 2mg/d for managing side effects.
- 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.
- 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.
- 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
- Symptom Distress [ Time Frame: baseline, 10 weeks and 8 months ]Urogenital distress inventory (UDI). Higher score indicates greater distress. Possible range 0 to 300.
- 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.
- Satisfaction [ Time Frame: 10 weeks ]Number of women who responded "completely satisfied" to question, "How satisfied are you with your progress?"
- Satisfaction [ Time Frame: 8 months ]Number of women who responded "completely satisfied" to question "How satisfied are you with your progress?"
- 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?"
- 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?"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00090584
|United States, Alabama|
|University of Alabama|
|Birmingham, Alabama, United States, 35233|
|United States, California|
|University of California|
|San Diego, California, United States, 92103|
|United States, Illinois|
|Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|United States, Maryland|
|University of Maryland|
|Baltimore, Maryland, United States, 21201|
|United States, Michigan|
|Oakwood Hospital and Medical Center|
|Royal Oak, Michigan, United States, 48123|
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Texas|
|University of Texas Southwestern|
|Dallas, Texas, United States, 75390|
|University of Texas Health Sciences Center|
|San Antonio, Texas, United States, 78229|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|
|Study Chair:||William D Steers, M.D.||University of Virginia|