Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence

Study Overview
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Brief Summary
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The primary objective of the double-blind phase of the study is to compare the effects of two doses of oxybutynin gel to placebo gel. The objective of the open-label extension is to evaluate the extended safety and skin-irritation profile of topically administered oxybutynin gel. The hypothesis is that topically administered oxybutynin gel will decrease (compared to placebo) the number of incontinence episodes per week, average daily urinary frequency, and urinary urgency; increase average urinary void volume; and improve patient quality of life.

Official Title
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A Double-Blind, Randomized, Parallel, Placebo-Controlled, Multicenter Study Evaluating the Effect of Treatment With Topically Administered Oxybutynin Gel in Patients With Urinary Frequency, and Urge and Mixed Urinary Incontinence With a Predominance of Urge Incontinence Episodes With an Open-Label Extension

Conditions
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Urge Urinary Incontinence, Urinary Frequency

Intervention / Treatment
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* Drug: Oxybutynin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overactive bladder (OAB) symptoms of urge and/or mixed UI with a predominance of urge incontinence for at least 3 months Have a history of at least 1 - 2 urge episodes and 8 or more voids per day Exclusion Criteria: Incontinence that is predominantly stress, insensate, or overflow in nature, or incontinence related to chronic illness, anatomical weakness/abnormalities or concomitant medications PVR volume > 200 mL or relative PVR > 50% of pre-void volume as determined by bladder ultrasound History of urinary retention, gastric retention, or uncontrollable narrow-angle glaucoma, or patients who are at risk for these conditions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxybutynin Gel 56 mg/day<br> | Drug: Oxybutynin<br>* Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo<br>* Other names: Anturol; Oxybutynin Gel 3%;Drug: Placebo<br>* Placebo Gel Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo<br>* Other names: Anturol; Oxybutynin Gel 3%;|
| Experimental: Oxybutynin Gel 84 mg/day<br> | Drug: Oxybutynin<br>* Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo<br>* Other names: Anturol; Oxybutynin Gel 3%;Drug: Placebo<br>* Placebo Gel Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo<br>* Other names: Anturol; Oxybutynin Gel 3%;|
| Placebo Comparator: Placebo Gel<br> | Drug: Oxybutynin<br>* Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo<br>* Other names: Anturol; Oxybutynin Gel 3%;Drug: Placebo<br>* Placebo Gel Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo<br>* Other names: Anturol; Oxybutynin Gel 3%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12 | Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline. | 12 weeks |