Non-instrumental biofeedback for fecal incontinence and constipation issues
Official title: Tratamiento de la Incontinencia Fecal y Los Trastornos Funcionales de la defecación Mediante Biofeedback no Instrumental
Run by Hospital Universitari Vall d'Hebron Research Institute · NCT06273046 · Data updated 2026-11-12
This study is testing if non-instrumental biofeedback techniques can help people with fecal incontinence and constipation feel better compared to a placebo.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 96 (estimated) |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Barcelona) |
| Status | Recruiting |
| Started | April 17, 2024 |
| Main results expected | April 30, 2026 |
| Study ends | August 30, 2026 |
| Registry record updated | June 15, 2026 |
| Trial ID | NCT06273046 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients experiencing fecal incontinence with at least four episodes in the last two weeks or those with constipation characterized by less than three bowel movements per week.
✕Probably not a fit
Patients with organic digestive diseases, neurological disorders, or a history of certain colorectal conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of non-instrumental biofeedback techniques in treating fecal incontinence and functional defecation disorders. It involves cognitive interventions using audiovisual programs designed specifically for managing anorectal functional disorders. Patients will be divided into two groups based on their condition: those with fecal incontinence and those with dyssynergic defecation. The study will assess the efficacy of these techniques compared to a placebo.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive and more cost-effective treatment option for patients suffering from fecal incontinence and constipation.
How similar studies have gone: While instrumental biofeedback has been established, this non-instrumental approach is relatively novel and has not been extensively tested in similar studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Hospital Vall d'Hebron
Barcelona, Spain Recruiting
Study contacts
- Principal investigator: Jordi Serra, MD — University Hospital Vall d'Hebron
- Study coordinator: Jordi Serra, MD
- Email: jordi.serra@vallhebron.cat
- Phone: 34 932746259
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.