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Clinical Trials/NL-OMON56038
NL-OMON56038
Completed
Not Applicable

Controlling Faecal incontinence with a novel anal device: a cost-effectiveness trial. (CONFIDEnCE) - CONFIDEnCE

niversiteit Maastricht0 sites73 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

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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