Non-instrumental biofeedback for fecal incontinence and constipation issues
Tratamiento de la Incontinencia Fecal y Los Trastornos Funcionales de la defecación Mediante Biofeedback no Instrumental
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06273046 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with organic digestive diseases, neurological disorders, or a history of certain colorectal conditions may not benefit from this study.
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 performed: While instrumental biofeedback has been established, this non-instrumental approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
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 this trial is running
Barcelona
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.