NCT00131573已完成3 期
Battery Powered Bion Clinical Investigation: Bion - An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urgency-Frequency Syndrome
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 21
- 主要终点
- Average Number of Voids Per Day
研究概览
简要总结
The goal of this study is to investigate the safety and effectiveness of a new implanted device designed to treat Urinary Urgency-Frequency Syndrome.
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
- 未提供
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 month period.
- •Less than one year post partum and/or are breast-feeding.
- •Have any large passive implant that contains metal located within 30 cm of the chair pad while seated (e.g., hip replacement).
- •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 pelvic pain in the absence of voiding dysfunction.
- •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.
- •Cannot independently comprehend and complete the questionnaires.
结局指标
主要结局
Average Number of Voids 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 (21)
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