Home Versus Office Biofeedback Therapy for Fecal Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Number of episodes of fecal incontinence
研究概览
简要总结
Biofeedback therapy is a labor-intensive, multi-disciplinary, team approach for the management of patients with Fecal Incontinence. It is not easily available to the vast majority of patients in the community with this problem. It is therefore imperative that a more pragmatic therapeutic approach that can be administered easily in the community ought to be developed. However, whether a treatment program that is based on home-training can be just as useful as office-based training has not been evaluated. The purpose of this study is to assess whether having patients train their pelvic floor muscles at home is as effective as in-office biofeedback training.
详细描述
The specific hypotheses that will be tested are:
-
Home training produces a similar degree of improvement as office biofeedback in
-
overall number of episodes of fecal incontinence
-
normalization of anorectal manometric pressures
-
Overall quality of life and symptom perception on previously validated Fecal Incontinence questionnaires
Thirty patients with fecal incontinence will be recruited for this eight week therapeutic investigation. Fecal Incontinence will be defined as at least 1 episode of solid or liquid stool leakage per week. All patients will provide a detailed history and undergo physical examination, structural (colonoscopy within 10 years) and anorectal manometry. Once eligible for screening, they will sign a consent form and maintain a 2-week prospective stool diary. If the diary confirms Fecal Incontinence and the inclusion criteria are met, they will be enrolled into the study.
After enrollment, patients will be randomized to receive either office-based biofeedback therapy or home-training.
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)
盲法说明
Everyone is masked to the assignment of home or office biofeedback training. Once the subject makes it to their treatment session, then everyone will know which one the subject has been allocated to.
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
- •recurrent episodes of fecal incontinence for six months
- •no mucosal disease
- •on a two week stool diary patient will report at least one episode of incontinence a week
排除标准
- •severe diarrhea
- •on opioids, tricyclics (except on stable doses > 3months)
- •active depression
- •comorbid illnesses, severe cardiac disease, chronic renal failure or previous gastrointestinal surgery except cholecystectomy and appendectomy
- •neurologic diseases (e.g. head injury, epilepsy, multiple sclerosis, strokes, spinal cord injury)
- •impaired cognizance (mini mental score of < 15) and/or legally blind
- •metal implants, pacemakers
- •previous pelvic surgery, bladder repair, radical hysterectomy
- •ulcerative and Crohn's colitis
- •rectal prolapse, anal fissure, anal surgery or inflamed hemorrhoids
- •pregnant women or nursing mothers
结局指标
主要结局
Number of episodes of fecal incontinence
时间窗: six weeks
Assess the change in the No of FI episodes between baseline week and end of study week and compare between the two treatment groups. Responder is defined as a patient with greater than 50% reduction in FI episodes after treatment when compared to baseline. Responder rates will compared between the two treatment groups.
次要结局
- Overall quality of life and symptom perception on previously validated Fecal Incontinence questionnaires(six weeks)
- Anal sphincter pressure and rectal sensation(six weeks)
- FI severity, quality of life and bowel symptoms(Six weeks)
- Treatment compliance with home biofeedback(Six weeks)
研究者
Satish Rao
Professor of Medicine, Division Chief Fellowship Program Director Director, Digestive Health Center
Augusta University