A Placebo-Controlled Study of Clonidine for Fecal Incontinence.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Mean Fecal Incontinence and Constipation Assessment (FICA) Score
研究概览
简要总结
Fecal incontinence is the involuntary leakage of stool from the anus. Doctors at Mayo Clinic are doing a research study to assess the effects of a medication, clonidine, on fecal incontinence and rectal functions in women. Clonidine has been approved by the Food and Drug Administration (FDA) for treating high blood pressure, but not for treating incontinence and rectal functions. The hypothesis of this study is clonidine will improve fecal incontinence, increase rectal capacity and reduce rectal sensation to a greater extent than placebo in women.
详细描述
Available therapeutic options for idiopathic fecal incontinence (FI) are limited and unsatisfactory. In addition to weak anal sphincters, our data suggest that reduced rectal capacity may contribute to rectal hypersensitivity and the symptom of rectal urgency in FI. During a 4 week study, oral clonidine restored rectal capacity and improved fecal continence in women with urge-predominant FI. Clonidine improves fecal continence and stool consistency in diarrhea-predominant irritable bowel syndrome (IBS). Therefore, we now propose a placebo-controlled study of clonidine for FI. Our aims are to (i) compare the effects of clonidine and placebo, to be given for 4 weeks, on symptoms, anal pressures, rectal compliance and sensation in women with FI. Forty four women (18-75 y) with urge predominant "idiopathic" FI and ≥ 4 episodes of FI during a 4 week screening period will be recruited to this study. Thereafter, patients will be treated with clonidine or placebo for 4 weeks. Bowel symptoms will be recorded in a diary. Anal sphincter pressures, rectal compliance and sensation will be evaluated before and during treatment with clonidine.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-75 years with urge predominant FI, as defined by a validated questionnaire, for greater than or equal to 1 year duration will be eligible to participate
- •Absence of organic disease (i.e., ulcerative colitis, cancer) as evidenced by colonoscopy, or barium enema and sigmoidoscopy within the last 3 years
排除标准
- •History of clinically significant cardiovascular or pulmonary disease or EKG abnormalities within the last 6 months [i.e., atrial flutter or fibrillation, sinus tachycardia (> 110/minute) or bradycardia (< 45 beats/minute), or prolonged corrected QT (QTc) interval (> 460 msec)
- •Current or past history of rectal cancer, scleroderma, inflammatory bowel disease, congenital anorectal abnormalities, greater than or equal to Grade 2 rectal prolapse, history of rectal resection or pelvic irradiation
- •Neurological disorders - Spinal cord injuries, dementia (Mini-mental status score <20/25), multiple sclerosis, Parkinson's disease, peripheral neuropathy
- •Conditions precluding safe use of clonidine, i.e., symptomatic hypotension, or systolic blood pressure of <100 mm Hg on initial screening visit
- •Pregnant or nursing women
- •Severe diarrhea during the run in phase defined as greater than 6 liquid stools daily (Bristol 6 or 7)
- •Medications: Absolute - opioid analgesics, anticholinergic drugs [low doses of tricyclic antidepressants, e.g., nortriptyline (up to 50 mg/day) or amitriptyline (up to 25 mg/day) will be permitted provided they were begun 3 months prior to the screening period]
- •Medications: Relative - other antihypertensive agents (i.e., if there is concern about synergistic effects and hypotension)
研究组 & 干预措施
Oral Clonidine
Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
干预措施: Clonidine (Drug)
Oral Placebo
Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Fecal Incontinence and Constipation Assessment (FICA) Score
时间窗: 4 weeks baseline, 4 weeks treatment
The FICA severity scale has 4 items (frequency, type, amount of leakage, and presence of urgency) and is used to rate the severity of fecal incontinence. The parameter was computed from values in the weekly diaries. The FICA score can range from 1 to 13. Symptom severity scores of 1-6, 7-10, and 11-13 are categorized as mild, moderate, and severe, respectively. Scores were averaged over the 4 week baseline period and the 4 week treatment periods.
次要结局
- Mean Number of Days With Fecal Incontinence(4 weeks baseline, 4 weeks treatment)
- Mean Number of Fecal Incontinence Episodes(4 weeks baseline, 4 weeks treatment)
- Mean Percentage of Bowel Movements Which Were Incontinent(4 weeks baseline, 4 weeks treatment)
- Mean Severity of Fecal Incontinence(4 weeks baseline, 4 weeks treatment)
- Impact of Fecal Incontinence on Baseline Quality of Life(4 weeks baseline)
- Impact of Fecal Incontinence on Post-Treatment Quality of Life(after 4 weeks treatment)
- Satisfaction With Treatment(4 weeks baseline, 4 week treatment)
- Percentage of Bowel Movements Preceded by Rectal Urgency(4 weeks baseline, 4 weeks treatment)
- Percentage of Bowel Movements With Semi-formed and Loose Stools in Subjects With and Without Diarrhea(4 weeks baseline, 4 weeks treatment)
- Percentage of Bowel Movements With Semi-formed and Loose Stools Post-treatment Adjusted for Baseline(4 weeks treatment)
- Percentage of Days With Fecal Incontinence (FI)(4 weeks baseline, 4 weeks treatment)
- Percentage of Days With FI Post-treatment Adjusted for Baseline(4 weeks treatment)