NCT03825575招募中不适用
Sacral Neuromodulation as Treatment for Fecal Incontinence
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in number of fecal incontinence episodes
研究概览
简要总结
The objective of this study is to investigate if low level laser therapy will do more good than harm for patients with severe refractory fecal incontinence. It is a proof of concept study without a placebo arm.
详细描述
The therapy consists of a 3 week treatment with a total of 8 sessions of low level laser therapy. Effects will be assessed using symptoms and quality of life questionnaires and physiological assessments of pelvic floor function, at 4 weeks and 12 weeks after beginning of treatment.
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
- 6 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with fecal incontinence
排除标准
- •Pregnant patients
- •Known malignancies in the area of treatment
- •Active bleeding in area of treatment
- •Active deep vein thrombosis
- •When tatoos are present at area of treatment
- •Patients that are light sensitive
- •Patients who take steroids.
结局指标
主要结局
Change in number of fecal incontinence episodes
时间窗: 4 weeks and 12 weeks
Number of fecal incontinence episodes per week
次要结局
- Change in anal sphincter tone(12 weeks)
- Change in increase of anal sphincter pressure during squeezing(12 weeks)
- Change in squeezing duration(12 weeks)
- Change in Quality of Life(4 weeks and 12 weeks)
- Change in symptoms score(4 and 12 weeks)
研究者
Jihong Chen
Assistant Professor
McMaster University
研究点 (2)
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