protocolSection identificationModule nctId: NCT06273046, orgStudyIdInfo id: PR(AG)614/2023, briefTitle: Treatment of Fecal Incontinence and Functional Defecation Disorders Using Non-instrumental Biofeedback, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-19, primaryCompletionDateStruct date: 2025-04-28, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Hospital Universitari Vall d'Hebron Research Institute, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Fecal Incontinence, conditions: Outlet Dysfunction Constipation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: Biofeedback, interventions name: Placebo, outcomesModule primaryOutcomes measure: Fecal incontinence study: Number of anal leaks, primaryOutcomes measure: Dyssinergic defecation study: Number of bowel movements, secondaryOutcomes measure: Incontinence study: Wexner scale, secondaryOutcomes measure: Incontinence study: Quality of life, secondaryOutcomes measure: Incontinence study: anxiety and depression, secondaryOutcomes measure: Incontinence study: Anal sphincter function, secondaryOutcomes measure: Dyssinergic defecation study: sensation of outlet obstructed evacuation, secondaryOutcomes measure: Dyssinergic defecation study: Wexner scale, secondaryOutcomes measure: Dyssinergic defecation study: Quality of life, secondaryOutcomes measure: Dyssinergic defecation study: anxiety and depression, secondaryOutcomes measure: Dyssinergic defecation study: defecatory maneuvers, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Vall d'Hebron, status: RECRUITING, city: Barcelona, country: Spain, contacts name: Jordi Serra, MD, role: CONTACT, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False