Controlling Faecal incontinence with a novel anal device: a cost-effectiveness trial. (CONFIDEnCE)
- Conditions
- Faecal incontinenceinvoluntary soiling10017977
- Registration Number
- NL-OMON56038
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 73
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method