Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe): a Randomized Placebo Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 9
- 主要终点
- Change From Baseline St. Mark's (Vaizey) Score
研究概览
简要总结
The study is a multi-center, randomized, placebo controlled trial with participants randomized into one of four groups:
- placebo/usual care (educational pamphlet)
- loperamide/usual care (educational pamphlet)
- placebo/anal exercises with biofeedback
- loperamide/anal exercises with biofeedback
The primary outcome, change from baseline in St. Marks (Vaizey) Score at 24 weeks, will be compared between treatment groups using linear regression.
详细描述
The goals of this trial are to compare the use of loperamide to oral placebo and to compare the use of anal sphincter exercise training with biofeedback to usual care (educational pamphlet) in the treatment of women suffering from fecal incontinence (FI). We will test the following null hypotheses:
- there is no difference in outcomes between women randomized to loperamide and women randomized to oral placebo for treatment of FI;
- there is no difference in outcomes between women randomized to anal sphincter exercises with biofeedback and women randomized to usual care (educational pamphlet) for FI treatment;
- there is no difference between women randomized to both treatments together and women randomized to either FI treatment alone; and
- there is no correlation between anal manometry measurements and digital anal squeeze strength or measures of FI severity and bother.
A supplemental study, Stool Metabolome and Microbiome in Women with Fecal Incontinence in CAPABLe, will evaluate the stool metabolome and microbiome in women with fecal incontinence and unaffected age matched controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Fecal incontinence defined as any uncontrolled loss of liquid or solid fecal material that occurs at least monthly over the last 3 months that is bothersome enough to desire treatment
排除标准
- •Stool consistency over the last 3 months that includes items 1 or 7 based on the Bristol Stool form scale
- •Current or past diagnosis of colorectal or anal malignancy
- •Diagnosis of inflammatory bowel disease
- •Current or history of rectovaginal fistula or cloacal defect
- •Rectal prolapse (mucosal or full thickness)
- •Prior removal or diversion of any portion of colon or rectum
- •Prior pelvic floor or abdominal radiation
- •Refusal or inability to provide written consent
- •Inability to conduct telephone interviews conducted in English or Spanish
- •Fecal impaction by exam
- •Untreated pelvic organ prolapse beyond the hymen; Patients with prolapse beyond the hymen who are currently using a pessary are eligible
- •Incontinence only to flatus
- •Has taken any loperamide (Imodium®) or diphenoxylate plus atropine (Lomotil®) in the last 30 days
- •Previously received and failed treatment of fecal incontinence using loperamide (Imodium®) or diphenoxylate plus atropine (Lomotil®) over the last 3 months
- •Current supervised anal sphincter exercise/pelvic floor muscle training with biofeedback
- •Previously received and failed treatment of fecal incontinence using supervised anal sphincter exercise/pelvic floor muscle training with biofeedback
- •Previous allergy or intolerance to loperamide
- •Pregnant, nursing, or planning to become pregnant before the end of the study follow-up period.
- •Childbirth within the last 3 months
- •Currently taking anti-retroviral drugs
- •Neurological disorders known to affect continence, including spinal cord injury, advanced multiple sclerosis or Parkinson's disease and debilitating stroke
- •Known diagnosis of hepatic impairment
- •Chronic abdominal pain in the absence of diarrhea
研究组 & 干预措施
Placebo - Exercise plus Biofeedback
Placebo and biofeedback intervention. Placebo doses range from 2mg every other day to 8mg per day. Capsules are taken by mouth once a day for 24 weeks.
Anal exercises with biofeedback intervention is a total of six sessions with trained personnel occurring every 2 weeks over a 12-week period. Sessions are held at the following study visits: baseline, 2, 4, 6, 9, and 12 week visits.
干预措施: Placebo (Drug)
Placebo - Exercise plus Biofeedback
Placebo and biofeedback intervention. Placebo doses range from 2mg every other day to 8mg per day. Capsules are taken by mouth once a day for 24 weeks.
Anal exercises with biofeedback intervention is a total of six sessions with trained personnel occurring every 2 weeks over a 12-week period. Sessions are held at the following study visits: baseline, 2, 4, 6, 9, and 12 week visits.
干预措施: Anal exercises with biofeedback (Behavioral)
Loperamide - Exercise plus Biofeedback
Loperamide and biofeedback intervention. Loperamide doses range from 2mg every other day to 8mg per day. Capsules are taken by mouth once a day for 24 weeks.
Anal exercises with biofeedback intervention is a total of six sessions with trained personnel occurring every 2 weeks over a 12-week period. Sessions are held at the following study visits: baseline, 2, 4, 6, 9, and 12 week visits.
干预措施: Loperamide (Drug)
Loperamide - Exercise plus Biofeedback
Loperamide and biofeedback intervention. Loperamide doses range from 2mg every other day to 8mg per day. Capsules are taken by mouth once a day for 24 weeks.
Anal exercises with biofeedback intervention is a total of six sessions with trained personnel occurring every 2 weeks over a 12-week period. Sessions are held at the following study visits: baseline, 2, 4, 6, 9, and 12 week visits.
干预措施: Anal exercises with biofeedback (Behavioral)
Placebo - Education Only
Placebo and education (usual care). Placebo doses range from 2mg every other day to 8mg per day. Capsules are taken by mouth once a day for 24 weeks.
Participants receive education and a NIDDK Bowel Control Educational pamphlet.
干预措施: Placebo (Drug)
Placebo - Education Only
Placebo and education (usual care). Placebo doses range from 2mg every other day to 8mg per day. Capsules are taken by mouth once a day for 24 weeks.
Participants receive education and a NIDDK Bowel Control Educational pamphlet.
干预措施: Usual Care (Behavioral)
Loperamide - Education Only
Loperamide and education (usual care). Loperamide doses range from 2mg every other day to 8mg per day. Capsules are taken by mouth once a day for 24 weeks.
Participants receive education and a NIDDK Bowel Control Educational pamphlet.
干预措施: Loperamide (Drug)
Loperamide - Education Only
Loperamide and education (usual care). Loperamide doses range from 2mg every other day to 8mg per day. Capsules are taken by mouth once a day for 24 weeks.
Participants receive education and a NIDDK Bowel Control Educational pamphlet.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Change From Baseline St. Mark's (Vaizey) Score
时间窗: 12 and 24 weeks
The primary outcome measure for all study arms is the change from baseline in St. Mark's (Vaizey) Score 24 weeks after treatment initiation to compare the marginal outcomes of anal exercise with biofeedback to usual care and loperamide to placebo. The St. Mark's (Vaizey) score, published in 1999, is commonly used in clinical studies and reports and was based on the Jorge-Wexner score but added two further items for assessment: the use of constipating medication and the presence of fecal urgency. Minimum score is 0 = perfect continence; maximum score is 24 = totally incontinent.
次要结局
- Change in Quality of Life on Colorectal-Anal Distress Inventory (CRADI)(12 and 24 weeks)
- Change in Colorectal-Anal Subscale of the Pelvic Floor Impact Questionnaire Short Form (CRAIQ) Score(12 and 24 weeks)
- Change From Baseline Accident-free Days at 12 and 24 Weeks(12 and 24 weeks)
- Change From Baseline Pad-change Leaks Per Day at 12 and 24 Weeks(12 and 24 weeks)
- Change From Baseline Pad-change Leaks Per Week at 12 and 24 Weeks(12 and 24 weeks)
- Change From Baseline Total Number of Leaks Per Day at 12 and 24 Weeks(12 and 24 weeks)
- Change in Fecal Incontinence Severity Index (FISI) Score(12 and 24 weeks)
- Participants With Improvement in Patient Global Impression of Improvement (PGI-I) Score(12 and 24 Weeks)
- Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks(12 and 24 weeks)
- Change From Baseline Volume of Air (mL) at First Sensation for Perception of Rectal Distention at 12 and 24 Weeks(12 and 24 weeks)
- Change From Baseline Volume of Air (mL) at Urge to Defecate at 12 and 24 Weeks(12 and 24 weeks)
- Change From Baseline Maximum Anal Pressures During Squeeze With the Catheter at the HPZ at 12 and 24 Weeks(12 and 24 weeks)