An interventional study of Transanal irrigation in Faecal Incontinence and Chronic Constipation, sponsored by Qufora A/S. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Qufora A/S · Not applicable, Interventional, and Other
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.
35 studies on the registry are indexed under Encopresis; 13 are open to participants now.
This study's planned enrollment of 66 is close to the median of 66 across 27 interventional studies indexed under Encopresis.
Browse Encopresis studies →Qufora A/S is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Transanal irrigation
Device: Transanal irrigation
Transanal irrigation by use of irrigation devices
Bowel Irrigation Questionnaire (BIQ) 4-point ordinal scale
Participant experience with device (0: strongly disagree, 4: strongly agree)
Time frame: Week 4, 10, 26, and 52
Patient Diary
Bowel irrigation frequency (times per week)
Time frame: Week 10, 26, and 52
Patient Diary
Bowel irrigation volume (in ml)
Time frame: Week 10, 26, and 52
Cleveland Clinic Constipation Score (CCCS)
Constipation severity (Higher scores indicate worse constipation symptoms; score range: 0-30)
Time frame: Week 0, 4, 10, 26, and 52
St Mark's Incontinence Score (SMIS
Fecal incontinence severity (Higher scores indicate worse incontinence symptoms; score range: 0-24)
Time frame: Week 0, 4, 10, 26, and 52
The 5-level EQ-5D (EQ-5D-5L) index score
General health-related quality of life (measure across five dimensions; higher levels indicate greater health impairment)
Time frame: Week 0, 4, 10, 26, and 52
No study locations are listed for this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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