NL-OMON56038
Completed
Not Applicable
Controlling Faecal incontinence with a novel anal device: a cost-effectiveness trial. (CONFIDEnCE) - CONFIDEnCE
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversiteit Maastricht
- Enrollment
- 73
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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.
Outcomes
Primary Outcomes
Not specified
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