Controlling Faecal Incontinence With a Novel Anal Device: a Cost-effectiveness Trial

Inclusion Criteria: For run in period * Patients with FI according to Rome IV criteria (i.e. recurrent uncontrolled passage of faecal matter for at least 3 months) * Aged between 16-90 years For randomisation and treatment period * Patients with FI according to Rome IV criteria (i.e. recurrent uncontrolled passage of faecal matter for at least 3 months) * Aged between 16-90 years * patients who experience at least 1 episode of accidental bowel leakage during the 2 week run-in period will be eligible for randomisation. Exclusion Criteria: * Insufficient cognitive skills to fill in patient-reported questionnaires, inability to present to hospital for screening visit and inclusion, neurological/psychiatric or physical inability to comply with the study protocol (including diary assessments) at the investigator's discretion, or insufficient command of the Dutch language. * Anatomic abnormalities: known communication between the anal and vaginal tracts, prior diagnosis of congenital anorectal malformations, previous rectal surgery, radiotherapy to a pelvic organ (uterus, prostate, rectum). * Prior diagnosis of inflammatory bowel disease. * Pregnancy or intention to become pregnant during the study period.