Treatment of Fecal Incontinence and Functional Evacuation Disorders Using Non-instrumental Biofeedback

Официальное название

Tratamiento de la Incontinencia Fecal y Los Trastornos Funcionales de la defecación Mediante Biofeedback no Instrumental

Обзор

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.

Вмешательства

• Поведенческое Biofeedback
  Three visits will be made throughout the study. The first visit (Day -14) will consist of an evaluation of the inclusion criteria. A pre-treatment anorectal manometry will be performed, and a daily symptom questionnaire will be given to the patient. The second visit will take place 14 days later (Day 0). During this visit, the daily clinical symptom questionnaire will be collected and it will be verified that the patient meets the inclusion criteria. Patients who meet the criteria will be random
• Поведенческое Placebo
  Three visits will be made throughout the study following the same procedure as patients in the active arm. Patients randomized to placebo treatment will receive instructions to take a pill of placebo containing 0.3 g glucose daily at home. A final visit will be performed at the end of the study alike the active treatment group.

Первичные конечные точки

• Fecal incontinence study: Number of anal leaks [Срок оценки: 3 months]
• Dyssinergic defecation study: Number of bowel movements [Срок оценки: 4 weeks]

Вторичные конечные точки (9)

• Incontinence study: Wexner scale [Срок оценки: 3 and 6 months]
• Incontinence study: Quality of life [Срок оценки: 3 months]
• Incontinence study: anxiety and depression [Срок оценки: 3 months]
• Incontinence study: Anal sphincter function [Срок оценки: 3 months]
• Dyssinergic defecation study: sensation of outlet obstructed evacuation [Срок оценки: 4 weeks]
• Dyssinergic defecation study: Wexner scale [Срок оценки: 4 weeks]
• Dyssinergic defecation study: Quality of life [Срок оценки: 4 weeks]
• Dyssinergic defecation study: anxiety and depression [Срок оценки: 4 weeks]
• Dyssinergic defecation study: defecatory maneuvers [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Vall d'Hebron — Barcelona

Публикации

• Serra J, Pohl D, Azpiroz F, Chiarioni G, Ducrotte P, Gourcerol G, Hungin APS, Layer P, Mendive JM, Pfeifer J, Rogler G, Scott SM, Simren M, Whorwell P; Functional Constipation Guidelines Working Group. European society of neurogastroenterology and motility guidelines on functional constipation in adults. Neurogastroenterol Motil. 2020 Feb;32(2):e13762. doi: 10.1111/nmo.13762. Epub 2019 Nov 22. PMID 31756783

Идентификаторы

NCT: NCT06273046 · PR(AG)614/2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗