NCT00080470已完成3 期
Battery Powered Bion Clinical Investigation: An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 11
- 主要终点
- Number of Leaks Per Day
研究概览
简要总结
This clinical trial is being conducted to investigate the safety and effectiveness of a new device designed to treat urinary urge incontinence in those patients who have tried and failed two or more conservative therapies.
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
- Single (Participant)
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
- •Age 18 years and above.
- •Diagnosed with urinary urge incontinence.
- •Have no reported history of urethral obstruction/stricture, bladder calculi or bladder tumor.
- •Have normal upper urinary tract function.
- •Be capable of giving informed consent.
- •Be capable and willing to follow all study related procedures.
排除标准
- •Have any active implantable device regardless of whether stimulation status is ON or OFF.
- •Are pregnant as confirmed by a urine pregnancy test or plan to become pregnant during the following 12 months period.
- •Less than one year post partum and/or are breast-feeding.
- •Have any passive implant that contains metal or electrically conductive materials.
- •Have conditions requiring Magnetic Resonance Imaging (MRI) evaluation.
- •Have conditions requiring diathermy procedures.
- •Have an inability to operate the bion Remote Control and bion Recharging System either by self or caregiver.
- •Have diabetes with peripheral nerve involvement or have severe uncontrolled diabetes.
- •Have history of coagulopathy or bleeding disorder.
- •Have a history of pelvic pain as primary diagnosis.
- •Have anatomical restrictions such that the study device placement is not possible.
- •Are currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function.
- •Have a life expectancy of less than 1 year.
- •Cannot independently comprehend and complete the QoL questionnaires.
研究组 & 干预措施
1
Experimental
Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
干预措施: bion (Device)
2
Sham Comparator
No Stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
干预措施: bion (Device)
结局指标
主要结局
Number of Leaks Per Day
时间窗: 12 months
Freedom From Major Complications
时间窗: 5 years
次要结局
未报告次要终点
研究者
研究点 (11)
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