Behavior Enhances Drug Reduction of Incontinence (BE-DRI)

Study Overview
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Brief Summary
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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.

Official Title
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Behavior Enhances Drug Reduction of Incontinence

Conditions
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Urinary Incontinence (UI)

Intervention / Treatment
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* Drug: Tolterodine
* Behavioral: Behavioral training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination therapy<br>Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication (tolterodine) and behavioral training. | Drug: Tolterodine<br>* 4mg/d for 10 weeks. Could be reduced to 2mg/d for managing side effects.<br>Behavioral: Behavioral training<br>* 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.<br>|
| Active Comparator: Drug therapy alone<br>Women assigned to this arm received 10 weeks of anti-cholinergic medication (tolterodine), only. | Drug: Tolterodine<br>* 4mg/d for 10 weeks. Could be reduced to 2mg/d for managing side effects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Women Who Meet Definition of Success | 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 | 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 | Change from baseline to 10 weeks in frequency of voids per day as reported on bladder diary | baseline and 10 weeks | 
| Symptom Distress | Urogenital distress inventory (UDI). Higher score indicates greater distress. Possible range 0 to 300. | baseline, 10 weeks and 8 months | 
| Symptom Bother | Disease specific overactive bladder scale (OAB-q). HIgher score indicates greater bother. Possible range 0 to 100. | baseline, 10 weeks and 8 months | 
| Satisfaction | Number of women who responded completely satisfied to question, How satisfied are you with your progress? | 10 weeks | 
| Satisfaction | Number of women who responded completely satisfied to question How satisfied are you with your progress? | 8 months | 
| Symptom Improvement | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urge urinary incontinence (UUI), Drug/Behavior treatment