Behavior Enhances Drug Reduction of Incontinence
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 307
- Locations
- 9
- Primary Endpoint
- Proportion of Women Who Meet Definition of Success
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Combination therapy
Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication (tolterodine) and behavioral training.
Intervention: Tolterodine (Drug)
Combination therapy
Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication (tolterodine) and behavioral training.
Intervention: Behavioral training (Behavioral)
Drug therapy alone
Women assigned to this arm received 10 weeks of anti-cholinergic medication (tolterodine), only.
Intervention: Tolterodine (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in Incontinence Episodes(Baseline and 10 weeks)
- Change in Voids Per Day(baseline and 10 weeks)
- Symptom Distress(baseline, 10 weeks and 8 months)
- Symptom Bother(baseline, 10 weeks and 8 months)
- Satisfaction(8 months)
- Symptom Improvement(8 months)