SUBCUTANEOUS TIBIAL NERVE STIMULATION FOR URGENCY URINARY INCONTINENCE: A FOLLOW-ON STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 12
- 主要终点
- Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
研究概览
简要总结
This trial is a prospective, multicenter, single-arm follow-on study will evaluate the safety and effectiveness of eCoinTM tibial nerve stimulation in subjects with urgency urinary incontinence (UUI) as defined by the American Urological Association (30). The follow-on study will evaluate changes from baseline in OAB symptoms as measured by voiding diaries and patient-reported outcomes through 24 weeks of eCoinTM therapy (which is the same as 28 weeks from study device reimplantation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individual participated in the eCoin Feasibility Study for Urgency Urinary Incontinence.
- •Individual was implanted with the study device during the eCoin Feasibility Study for Urgency Urinary Incontinence.
排除标准
- •In the opinion of the investigator, individual is not a good candidate for participation in the study.
结局指标
主要结局
Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
时间窗: 12 weeks after device activation.
Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 4 Months After Implantation.
时间窗: 16 weeks after device implantation.
Instances of a related adverse event.
次要结局
- Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 6 Months After Implantation.(28 weeks after device implantation.)
- Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.(24 weeks after device activation.)