NCT02619721Unknown1 期
Clinical Trial of Sacral Neuromodulation for Treatment of Refractory Overactive Bladder (OAB)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Changes in voiding frequency from baseline to the voiding frequency evaluvation period 6 month
研究概览
简要总结
Evaluate the long-term clinical effectiveness and safety of the PINS Sacral Neuromodulation to patients with refractory Overactive Bladder.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 16 years OAB and/or OAB symptoms Refractory to standard medical therapy 100ml bladder capacity with normal upper urinary tract Good surgical candidate Able to complete study documentation and return for followup evaluation
排除标准
- •Neurological conditions Stress urinary incontinence OAB symptoms caused by urinary tract infections
研究组 & 干预措施
Sacral Neuromodulation is on
Experimental
Sacral Neuromodulation is on as soon as implantation
干预措施: PINS SNS (Device)
Sacral Neuromodulation is off
Placebo Comparator
Sacral Neuromodulation is off after implantation
干预措施: PINS SNS (Device)
结局指标
主要结局
Changes in voiding frequency from baseline to the voiding frequency evaluvation period 6 month
时间窗: 6 month of stimulation
次要结局
未报告次要终点
研究者
研究点 (1)
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