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

NARecruitingINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

April 17, 2024

Primary Completion Date

April 30, 2026

Study Completion Date

August 30, 2026

Conditions
Fecal IncontinenceOutlet Dysfunction Constipation
Interventions
BEHAVIORAL

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.

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.

Trial Locations (1)

Unknown

RECRUITING

Hospital Vall d'Hebron, Barcelona

All Listed Sponsors
lead

Hospital Universitari Vall d'Hebron Research Institute

OTHER