Treatment of Fecal Incontinence and Chronic Constipation With Low-volume Irrigation (NCT05773742) | Clinical Trial Compass
CompletedNot Applicable
Treatment of Fecal Incontinence and Chronic Constipation With Low-volume Irrigation
Denmark92 participantsStarted 2023-04-17
Plain-language summary
The aim of this study is to investigate the efficacy of low-volume irrigation on bowel function among patients with fecal incontinence and/or chronic constipation (of heterogenous origin).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with FI, CC or co-existing FI and CC of heterogenous origin.
* Positive Rome IV criteria for constipation and/or positive Rome IV criteria for fecal incontinence.
* Patients with Bristol stool type 1-5 as their primary stool consistency.
* 18 years.
* Ability to understand written and spoken Danish (due to questionnaire validity).
Exclusion Criteria:
* Prior use of transanal irrigation or mini enema.
* Patients with chronic diarrhea (Bristol stool type 6-7).
* Patients with neurogenic bowel dysfunction.
* Participation in research conflicting with the current study.
* Diseases treated with rectal or anal surgery (except minor rectal or anal surgery).
* Physical disability that affects the ability to use QuforaÃ’ IrriSedo MiniGo.
* Major psychiatric diagnoses.
* Patients with constipation with a chronic opioid use or other medications inducing constipation.
* Pregnancy or plans to become pregnant.