Conditions: Urge Urinary Incontinence Urinary Frequency
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 626
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Oxybutynin intervention 2: Placebo
Intervention descriptions: intervention 1: 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 intervention 2: 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

Protocol document: