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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 626
- 主要终点
- Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Oxybutynin Gel 56 mg/day
干预措施: Oxybutynin (Drug)
Oxybutynin Gel 56 mg/day
干预措施: Placebo (Drug)
Oxybutynin Gel 84 mg/day
干预措施: Oxybutynin (Drug)
Oxybutynin Gel 84 mg/day
干预措施: Placebo (Drug)
Placebo Gel
干预措施: Oxybutynin (Drug)
Placebo Gel
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12
时间窗: 12 weeks
Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline.
次要结局
未报告次要终点