Treating Anorectal Dysfunction Associated With Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Number of Participants With 30% Improvement From Baseline in Bowel Symptoms at 4 Weeks
研究概览
简要总结
The investigators seek to test whether incorporating the scheduled dosing of a bisacodyl 10 mg rectal suppository every other day improves bowel-related symptoms in patients with multiple sclerosis. Patients will be randomized to receive either a placebo suppository or bisacodyl suppository dosed every other day for 4 weeks.
详细描述
The majority of patients with multiple sclerosis (MS) suffer from some form of anorectal dysfunction, and these difficulties with bowel function are often ranked as negatively impactful on quality of life as impaired mobility. Despite the significant clinical burden of these symptoms, there remains a paucity of published literature supporting specific therapeutic options to manage anorectal dysfunction in this clinical population. Most bowel regimens rely on either oral laxatives (i.e. PEG-3350) or anti-diarrheal agents (i.e. loperamide). In their study, the investigators propose to establish the efficacy of a bowel regimen that combines both oral agents (as needed; standard care) with scheduled, every other day dosing of a placebo or stimulant laxative rectal suppository -- bisacodyl 10 mg.
Bisacodyl is a stimulant laxative medication that is available over-the-counter. It works by activating nerves in the rectum to elicit rectal contractions which ultimately leading to defecation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MS patients with mild to moderately severe disease (Multiple Sclerosis Impact Scale [MSIS-29] physical domain scores <61 or equivalent Extended Disability Severity Score [EDSS] < 6.5) of any age, gender, disease subtype, duration of illness, current use of MS disease modifying therapy, or comorbid medical condition AND who also have anorectal dysfunction (chronic constipation and/or fecal incontinence) are eligible.
排除标准
- •MS patients with severe disease (MSIS-29 physical domain scores greater than 61 or equivalently severe EDSS greater than 6.5), patients with surgically altered anorectal anatomy (i.e. proctectomy/partial colectomy, ostomy creation), active enteric infection (i.e., Clostidium Difficile), or inflammatory bowel disease (i.e. ulcerative proctitis, ulcerative colitis) will also be excluded.
研究组 & 干预措施
Placebo
Every other day placement of a placebo rectal suppository for 4 weeks
干预措施: Placebo (Other)
Bisacodyl
Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks
干预措施: Bisacodyl (Drug)
结局指标
主要结局
Number of Participants With 30% Improvement From Baseline in Bowel Symptoms at 4 Weeks
时间窗: Baseline, 4 weeks
All subjects were asked the following question at study entry ('baseline') and the end of 4 weeks of intervention: "Using a scale of 1 to 10 (1 being no problem and 10 being maximally impactful symptoms), how would you rate the severity of your bowel symptoms over the past 2 weeks?" The range of reported values was 2-9. We took a response to be a 30% decrease (i.e. improvement) in the subjective symptom score between the baseline and 4 week assessment.
次要结局
- Change From Baseline in Fecal Incontinence Quality of Life (FIQL) Score at 4 Weeks(Baseline, 4 weeks)
- Change From Baseline in SF-36 Scores at 4 Weeks(Baseline, 4 weeks)
- Change From Baseline In Percent of Subjects With Normal Average Stool Form at 4 Weeks(Baseline, 4 weeks)
- Change From Baseline in Mean PAC-SYM Subscale Scores at 4 Weeks(Baseline, 4 weeks)
- Change From Baseline in Fecal Incontinence Severity Index (FISI) Score at 4 Weeks(Baseline, 4 Weeks)
- Change From Baseline in PAC-QOL Scores at 4 Weeks(Baseline, 4 weeks)
- Change From Baseline In Average Number of Daily Bowel Movements at 4 Weeks(Baseline, 4 weeks)
- Change From Baseline In Average Number of Fecal Incontinence Episodes at 4 Weeks(Baseline, 4 weeks)
研究者
David Levinthal
Assistant Professor
University of Pittsburgh