NCT07473622

Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence

Outcome Research in Bowel Irrigation Techniques: A Novel Self-retaining Catheter Compared With a Conventional Balloon Catheter for the Treatment of Chronic Constipation and/or Faecal Incontinence, a Real-world Randomised Explorative Investigation.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Qufora A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Faecal Incontinence
• Chronic Constipation

Interventions

Type	Name	Description
DEVICE	Transanal irrigation	Transanal irrigation by use of irrigation devices

Timeline

• Start date: 2026-08-01
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2026-03-16
• Last updated: 2026-03-16