Electrical Rectal Stimulation to Promote Bowel Emptying After Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Time required to complete bowel emptying
研究概览
简要总结
The investigators are testing the effect of electrical stimulation of the rectum on colonic motility. Most individuals with spinal cord injury develop neurogenic bowel dysfunction, which includes slowed colonic motility, which means that stools take longer than normal to pass through the colon. This slowed movement may result in chronic constipation and difficulty emptying the bowels. Individuals typically (without or without caregiver assistance) insert a gloved finger into the rectum and gently stretch it to improve colonic motility for a brief period to empty the bowels. The investigators hypothesize that electrically stimulating the rectum, instead of mechanically stretching it, will produce the same beneficial effect of improving colonic motility. Therefore, this study will compare the two methods. If electrical stimulation effectively improves colonic motility, then the investigator shall develop the approach as a therapeutic intervention in future studies.
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
- •Suprasacral spinal cord injury
- •Diagnosed neurogenic bowel dysfunction and using digital rectal stimulation
- •Bowel routine requires at least 30 minutes or at least 3 cycles of digital rectal stimulation
- •Neurologically stable
- •At least 18 years old
- •At least 12 months post neurological injury or disease diagnosis
排除标准
- •Active sepsis
- •Open pressure sores on or around pelvis
- •Significant colon trauma or colostomy
- •Crohn's disease
- •Colonic obstruction or gastrointestinal surgery within last 3 months
- •Significant history of autonomic dysreflexia
研究组 & 干预措施
Bowel emptying
Study participants will act as their own controls, first providing data using their usual digital rectal stimulation intervention for bowel care, then providing data using electrical stimulation for bowel care.
干预措施: Electrical Rectal Stimulation (Other)
结局指标
主要结局
Time required to complete bowel emptying
时间窗: 12 weeks
Two interventions will be tested, including the clinical standard of digital rectal stimulation and a novel approach using electrical stimulation of rectal sensory afferents, to determine the effect on colonic pressure. We will compare the time required for the participant to complete their bowel emptying routine between a control period with digital rectal stimulation and a treatment period with electrical rectal stimulation.
次要结局
未报告次要终点