Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Condition(s) studied
Investigational drug(s) / intervention(s)
Transanal irrigation: Transanal irrigation by use of irrigation devices
Study summary
This clinical investigation is a post-market, exploratory, randomised, parallel, open-label investigation comparing two UKCA/CE-marked transanal irrigation products for the management of faecal incontinence and/or chronic constipation of heterogenous origin. The aim of this investigation is to assess outcomes in a real-world clinical setting, by following the typical clinical routine, with randomisation and more frequent visits/phone calls as the only difference from typical clinical procedure.
During 4-week training period, participants will trained by nurse specialists on how to use the device to which they were randomised to and will be instructed to irrigate once per day. For the remainder of the investigation, participants will be advised to continue irrigation once daily (or a minimum of 3 times a week). Participants will be followed up via phone call or in-person visit up to 52 weeks.
Eligibility
Primary outcome measure(s)
- Bowel Irrigation Questionnaire (BIQ) 4-point ordinal scale — Week 4, 10, 26, and 52
Participant experience with device (0: strongly disagree, 4: strongly agree)
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| University Hospital Southampton | Southampton | United Kingdom | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07473622 on ClinicalTrials.gov ↗ ← All trials in the UK