Title
Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence
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
Phase
Phase 3Lead Sponsor
Antares Pharma Inc.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Urge Urinary Incontinence Urinary FrequencyIntervention/Treatment
oxybutynin ...Study Participants
626The 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.
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
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
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
| Event Type | Organ System | Event Term | Oxybutynin Gel 56 mg/Day | Oxybutynin Gel 84 mg/Day | Placebo Gel |
|---|
Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline.
