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

NCT ID: NCT06273046

Last Updated: 2025-07-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-17
• Study Completion Date: 2026-08-30

Brief Summary

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.

Conditions

Fecal Incontinence; Outlet Dysfunction Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Biofeedback

Group Type: EXPERIMENTAL

Biofeedback

Intervention Type: BEHAVIORAL

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 randomized 2:1 to active treatment or placebo. Patients will receive instructions, by means of psychoeducational videos on the exercises to be performed daily at home. A final visit will be performed at the end of the study (3 months in incontinence studies and 4 weeks in dyssynergic defecation studies). In incontinence study a final phone call will be performed at 6 months.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BEHAVIORAL

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.

Interventions

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 randomized 2:1 to active treatment or placebo. Patients will receive instructions, by means of psychoeducational videos on the exercises to be performed daily at home. A final visit will be performed at the end of the study (3 months in incontinence studies and 4 weeks in dyssynergic defecation studies). In incontinence study a final phone call will be performed at 6 months.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jordi Serra, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Vall d'Hebron

Locations

Hospital Vall d'Hebron

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Jordi Serra, MD

Role: CONTACT

jordi.serra@vallhebron.cat

34 932746259

Gloria Santaliestra

Role: CONTACT

gloria.santaliestra@vhir.org

Facility Contacts

Jordi Serra, MD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 31756783 (View on PubMed)

Other Identifiers

PR(AG)614/2023

Identifier Type: -

Identifier Source: org_study_id