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
Overview
- Phase
- Phase 3
- Intervention
- Oxybutynin
- Conditions
- Urge Urinary Incontinence
- Sponsor
- Antares Pharma Inc.
- Enrollment
- 626
- Primary Endpoint
- Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Oxybutynin Gel 56 mg/day
Intervention: Oxybutynin
Oxybutynin Gel 56 mg/day
Intervention: Placebo
Oxybutynin Gel 84 mg/day
Intervention: Oxybutynin
Oxybutynin Gel 84 mg/day
Intervention: Placebo
Placebo Gel
Intervention: Oxybutynin
Placebo Gel
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12
Time Frame: 12 weeks
Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline.