Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Percentage of Bowel Movements With Incontinence
研究概览
简要总结
The purpose of this study is to evaluate and compare treatment with fiber and loperamide for fecal incontinence.
详细描述
Fecal incontinence (FI) affects 4-24% adults in the community and greatly impacts quality of life. Both fiber and loperamide are common, first-line treatments for diarrhea-associated FI in primary care. No known studies exist that compare fiber and loperamide for diarrhea-predominant FI. Further knowledge is needed to define which treatment is more effective and to compare drug tolerability (side effects) for FI. This study will also look at changes in quality of life with treatment and potential mechanisms of drug treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •weekly fecal incontinence
排除标准
- •fecal impaction
- •inability to complete a baseline 1-week bowel diary
- •rectal prolapse
- •any prior radiation to the pelvis
- •colo-rectal cancer
- •rectal fistula
- •inflammatory bowel disease
- •neurological diseases (spinal cord injury, multiple sclerosis, Parkinson's disease)
- •constipation (<2 bowel movements/week) or total colectomy
研究组 & 干预措施
Arm 1
Fiber (psyllium) powder
干预措施: Psyllium powder (Drug)
Arm 2
Loperamide
干预措施: Loperamide (Drug)
结局指标
主要结局
Percentage of Bowel Movements With Incontinence
时间窗: 4 weeks
After consent, 7-day bowel diary was assessed at baseline (2-week visit), during the last week of the 4-week intervention (6-week visit), during the second week of the 2-week wash-out period at 8-weeks, and during the last week of the second 4-week intervention (12 weeks). We compared the percentage of the total number of fecal incontinence episodes over the total number of bowel movements from a 7-day bowel diary from each time point between the groups.
7-day Bowel Diary, Number of Fecal Incontinence Episodes
时间窗: 6 weeks and 12 weeks
After consent, 7-day bowel diary was assessed at baseline (2-week visit), during the last week of the 4-week intervention (6-week visit), during the second week of the 2-week wash-out period at 8-weeks, and during the last week of the second 4-week intervention (12 weeks). The mean number of total fecal incontinence episodes from a 7-day bowel diary from each time point was compared between the groups.
次要结局
- Fecal Incontinence Severity Index Score, FISI(baseline, 4 week and 12 weeks)