Tratamiento de la Incontinencia Fecal y Los Trastornos Funcionales de la defecación Mediante Biofeedback no Instrumental
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Fecal incontinence study: Number of anal leaks
研究概览
简要总结
Background. Rehabilitation and re-education using instrumental anorectal biofeedback are the main treatment of anorectal functional disorders producing incontinence and outlet obstructed defecation. These treatments imply intubation of patient and several sessions of treatment leading to high consumption of resources and costs.
Hypothesis. A cognitive intervention based on original audiovisual programs developed specifically for the management of anorectal functional disorders is effective in correcting anorectal function disorders that cause fecal incontinence and evacuation disorders.
Aim. To prove in two different protocols (fecal incontinence and dyssinergic defecation) the efficacy of specifically developed non-instrumental biofeedback techniques.
Selection criteria. Patients with fecal incontinence and altered sphincter function and patients with outlet obstructed evacuation referred for biofeedback treatment.
Intervention. In separate studies (incontinence and dyssynergic defecation) patients will be randomized into biofeedback and placebo groups. One session of either biofeedback or placebo intervention will be performed at the beginning of the intervention period and patients will be instructed to performed the assigned daily treatment at home. A visit for outcome assessment will be performed at 3 months in incontinence study and at 4 weeks in the dyssinergic defecation study. In addition, in the incontinence study a phone call will be performed after 6 months of the beginning of the study to evaluate treatment outcome.
Biofeedback: patients will be taught to control anal and abdominal muscular activity by providing instructions using original video supports. Patients will be instructed to perform the same exercises daily at home in scheduled times.
Placebo: a pill of placebo containing 0.3 g glucose will be administered every day at home.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Incontinence studies
- •Patients who have at least 4 episodes of fecal incontinence during the last 14 days.
- •Patients able to follow instructions and attend study visits.
- •Dyssinergic defecation studies
- •Patients with constipation who present less than 3 complete spontaneous bowel movements per week and/or who have Bristol 1 or Bristol 2 type stools in more than 25% of the bowel movements in the 2 weeks prior to the study
- •Patients able to follow instructions and attend study visits.
排除标准
- •Patients with organic digestive diseases such as inflammatory bowel disease, celiac disease, gastro-duodenal ulcer...
- •Patients with neurological diseases (spinal cord injury, multiple sclerosis, Parkinson's disease).
- •Patients with previous of active colon and/or rectal cancer.
- •Patients with rectal fistula.
- •Patients with rectal prolapse.
- •Patients with total colectomy.
- •Patients who have had any radiation to the pelvis in the last month.
研究组 & 干预措施
Biofeedback
干预措施: Biofeedback (Behavioral)
Placebo
干预措施: Placebo (Behavioral)
结局指标
主要结局
Fecal incontinence study: Number of anal leaks
时间窗: 3 months
Number of involuntary leaks during the last 15 days of study compared to the 15 days prior to treatment start.
Dyssinergic defecation study: Number of bowel movements
时间窗: 4 weeks
Number and type (according to Bristol scale) of bowel movements during the last 15 days of study compared to the 15 days prior to treatment start.
次要结局
- Incontinence study: Quality of life(3 months)
- Incontinence study: Anal sphincter function(3 months)
- Dyssinergic defecation study: Quality of life(4 weeks)
- Dyssinergic defecation study: sensation of outlet obstructed evacuation(4 weeks)
- Incontinence study: anxiety and depression(3 months)
- Dyssinergic defecation study: Wexner scale(4 weeks)
- Dyssinergic defecation study: anxiety and depression(4 weeks)
- Incontinence study: Wexner scale(3 and 6 months)
- Dyssinergic defecation study: defecatory maneuvers(4 weeks)