N/A
Completed N=307
Behavior Enhances Drug Reduction of Incontinence (BE-DRI)
Urinary Incontinence (UI)
Source: ClinicalTrials.gov NCT00090584 ↗
Enrolled (actual)
307
Serious AEs
1.3%
Results posted
Jun 2013
Primary outcomePrimary: Proportion of Women Who Meet Definition of Success — 43; 41 participants — p=0.74
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Women Who Meet Definition of Success |
43; 41 | 0.74 |
| SECONDARY Change in Incontinence Episodes |
-20.4; -18.5 | 0.34 |
| SECONDARY Change in Voids Per Day |
-0.5; 0.3 | 0.08 |
| SECONDARY Symptom Distress |
121.4; 47.3; 61.9; 118.2; 58.1; 83.3 | 0.0006 sig |
| SECONDARY Symptom Bother |
59.9; 23.1; 29.0; 60.0; 29.6; 39.6 | 0.0005 sig |
| SECONDARY Satisfaction |
38; 25 | 0.02 sig |
| SECONDARY Symptom Improvement |
80; 54 | <0.0001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00090584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.