Behavior Enhances Drug Reduction of Incontinence (BE-DRI) (BE-DRI)
|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|
|Urinary Incontinence (UI)||Drug: Tolterodine Behavioral: Behavioral training|
|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|
|Primary Completion Date :||December 2005|
|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?"
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|