NCT05688644Enrolling By Invitation不适用
Efficacy and Safety of Sacral Neuromodulation With InterStim II in Neurogenic Bladder and/or Bowel Patients
Omri Schwarztuch Gildor1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年12月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Decrease of at least 50% in number of catheterizations per day
研究概览
简要总结
The goal of this observational study is to evaluate efficacy and safety of sacral neuromodulation in neurogenic patients compared to non-neurogenic (idiopathic) patients. [. The main question[s] it aims to answer are:
- determine efficacy and safety of the therapy in neurogenic patients.
- compare outcomes of the therapy to idiopathic patients.
If there is a comparison group: Researchers will compare the outcomes of the therapy between the neurogenic and non-neurogenic subset of patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients who underwent InterStim II advanced evaluation for approved indication
排除标准
- 未提供
结局指标
主要结局
Decrease of at least 50% in number of catheterizations per day
时间窗: 1 year
Decrease of at least 50% in number of fecal incontinence episodes
时间窗: 1 year
Decrease of at least 50% in number of urge urinary incontinence episodes
时间窗: 1 year
次要结局
- Number of revision surgeries(1 year)
- number of follow-up visits for programming and/or troubleshooting(1 year)
研究者
Omri Schwarztuch Gildor
Urologist
Clalit Health Services
研究点 (1)
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