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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
66
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.