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

RecruitingNAAges 18 Years - 75 YearsAllHospital Universitari Vall d'Hebron Research Inst…
NCT06273046 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ref

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📋 Eligibility rules (as published)
Inclusion Criteria: 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. Exclusion Criteria: * 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.
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What it tests

  • Biofeedback
  • Placebo
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Where

1 site
Hospital Vall d'Hebron
Barcelona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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