NCT01666405终止1 期
A Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Effectiveness
研究概览
简要总结
The purpose of this study is to determine the effectiveness of percutaneous tibial nerve stimulation (PTNS) therapy with the Urgent® PC Neuromodulation System (Uroplasty, Inc., Minnetonka, MN, USA) for the treatment of fecal incontinence (FI).
详细描述
Pilot Study
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient history of chronic FI of more than staining for at least 6 months; staining defined as less than the size of a 25¢ piece (quarter)
- •Patient reported and/or failed ≥ 2 conservative therapies (e.g., diet/fiber modification, anti-diarrheal medication, pelvic floor muscle training, biofeedback, medical management, etc.)
排除标准
- •Pregnancy or intention to become pregnant during the course of the study
- •Implanted electro-medical device (i.e., pacemaker, defibrillator, deep brain stimulator, etc.)
- •Clinically significant neurological diseases or nerve damage impacting tibial nerve or pelvic floor function
- •Prone to excessive bleeding or bleeding diathesis
研究组 & 干预措施
Urgent(R) PC Neuromodulation System
Experimental
Urgent(R) PC Neuromodulation System
干预措施: Urgent(R) PC Neuromodulation System (Device)
结局指标
主要结局
Effectiveness
时间窗: 18 weeks
To assess the effectiveness of PTNS by measuring the proportion of patients with ≥50% decrease in the number of fecal incontinence episodes per week based on the results of the 14-day bowel diary at 18 weeks compared to baseline
Safety
时间窗: 18 weeks
To characterize adverse events experienced throughout the study
次要结局
未报告次要终点
研究者
研究点 (6)
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