Electrical Field Stimulation for the Treatment of Urge Urinary Incontinence and Overactive Bladder - Version: 3.0 Dated 16 APR 2012.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 130
- 主要终点
- Reduction of incontinence episodes from baseline to follow-up greater for device arm than sham arm
研究概览
简要总结
The purpose of this study is to collect data on the safety and efficacy of using an electrical field stimulation device, compared to a sham (placebo) device, to treat urinary urgency, urinary frequency and urge incontinence.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Urinary Urge Incontinence
- •Urinary Frequency
排除标准
- •Primary complaint of Stress Incontinence
- •Neurogenic bladder
- •Overflow Incontinence
- •Functional Incontinence
结局指标
主要结局
Reduction of incontinence episodes from baseline to follow-up greater for device arm than sham arm
时间窗: One week after final treatment visit
Significant increase in the percentage of patients reporting a reduction in number of incontinence episodes per day for the investigational device vs. sham
No Serious Adverse Events or Unanticipated Adverse Device Effects
时间窗: First treatment through follow-up (one week after last treatment)
Freedom from Serious Adverse Events or Unanticipated Adverse Device Effects related to procedure and/or investigational device through follow-up
次要结局
未报告次要终点