NCT04001426已完成不适用
Pilot Phase for an Acute Evaluation of a Non-Implantable Electrical Continence Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Evoked Potential response
研究概览
简要总结
The purpose of this feasibility clinical investigation is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.
详细描述
The FemPulse System is a vaginal ring intended to provide mild electrical stimulation to nerves that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Normal healthy women ≥ 21 years old
- •Using contraception if of reproductive age
排除标准
- •Pregnant, recently pregnant or actively trying to conceive
- •Prior hysterectomy
- •Current or recent urinary tract or vaginal infection
结局指标
主要结局
Evoked Potential response
时间窗: Up to 6 hours
Surface electrodes will be used to detect whether evoked potentials are generated during device activation
Autonomic nervous system response
时间窗: Up to 6 hours
The Quantitative Sudomotor Axon Reflex Test (QSART) will be used to detect changes in autonomic nervous system activity during device activation
次要结局
未报告次要终点
研究者
研究点 (2)
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