The Use of the Peristeen Bowel Irrigation System for People With Cauda Equina Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change from baseline on Cleveland Clinic Constipation Scoring System after 10 weeks of treatment
研究概览
简要总结
To compare the Peristeen Anal Irrigation System with conservative bowel management in a prospective study among spinal cord injured patients with lower motor neuron neurogenic bowel dysfunction.
详细描述
People with spinal cord injury (SCI) often have severe problems with management of bowel function, including incontinence, impaction, lengthy bowel routines and extremely slow transit times.The anal irrigation system is a recently available system to help patients with bowel dysfunction empty their bowels by using pulse water irrigation. The system consists of a rectal balloon catheter, manual pump and water container.
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
- •Male or female >18 years or older
- •Cauda equina spinal injury at least 12 months previously, with lower motor neuron bowel dysfunction and at least one of the following symptoms:
- •Spending 30 minutes or more attempting to defecate each day or every second day
- •Episodes of fecal incontinence once or more per month
- •Abdominal discomfort before or during defecation
排除标准
- •Coexisting major unresolved physical problems due to the injury
- •Performance of transanal irrigation on a regular basis
- •Evidence of bowel obstruction or active inflammatory bowel disease
- •History of cerebral palsy, stroke, multiple sclerosis or diabetic polyneuropathy
- •Previous colorectal or perineal surgery(excluding minor surgery such as hemorrhoidectomy)
- •Pregnancy or lactation
- •Immunosuppression
- •Prior implant for sacral nerve stimulation
结局指标
主要结局
Change from baseline on Cleveland Clinic Constipation Scoring System after 10 weeks of treatment
时间窗: At baseline Visit and again after 10 weeks of treatment
A scoring system with a range of 0-30, with 30 representing the most severe symptoms. Will be used for volunteers whose primary complaint at baseline is constipation.
Change from baseline on the St. Mark's Fecal Incontinence Grading System after 10 weeks of treatment.
时间窗: At baseline and again after 10 weeks of treatment
A Grading system with a range of 0-24, with 24 representing the most severe symptoms. This will be used for volunteers whose primary complaint at baseline is fecal incontinence.
次要结局
- Measurement of Influence of Current Bowel Management on Quality of Life(After 10 weeks of treatment)
- Change from baseline in The Neurogenic Bowel Dysfunction Score after 10 weeks of treatment(At baseline and again after 10 weeks of treatment)
- Change from baseline on a numeric box scale to measure bowel function, influence on daily activities, and general satisfaction after 10 weeks of treatment.(At baseline and after 10 weeks of treatment.)
- Change from baseline in a modified American Society of Colon and Rectal Surgeons fecal incontinence score after 10 weeks of treatment.(At baseline and again after 10 weeks of treatment)
- Change from baseline measurement of Colonic Transit Time (CTT)after 10 weeks of treatment(At baseline and again after 10 weeks of treatment.)
研究者
Dr. Karen Ethans
Director, Spinal Cord Injury Rehabilitation Program
University of Manitoba