Urge Urinary Incontinence Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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