Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorQufora A/S
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Faecal incontinence (FI), chronic constipation (CC) or co-existing FI/CC, all of heterogenous origin
Positive Rome IV criteria for functional constipation and/or positive Rome IV criteria for faecal incontinence
18 years or older
Ability to understand written and spoken English (due to questionnaire validity)
Disqualifiers
Prior use of transanal irrigation
Neurogenic bowel dysfunction
Low anterior resection syndrome (this group will be excluded due to the possibility of being randomised to a balloon catheter).
Previous rectal and/or anal surgery (except minor rectal or anal surgery such as haemorrhoid procedures, anal fissure surgery, drainage of a perianal/rectal abscess, or other rectal or anal surgeries deemed minor by the investigator)
Trial design
Design model
Parallel
Treatments tested in this trial
Transanal irrigation
DeviceTransanal irrigation by use of irrigation devices
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Qufora QNovaExperimental treatment 1 intervention
Group B: Qufora Irrisedo KlickActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 52Secondary outcomes
1
Patient Diary
Bowel irrigation frequency (times per week)
Time frame
Week 10, 26, and 522
Patient Diary
Bowel irrigation volume (in ml)
Time frame
Week 10, 26, and 523
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 524
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 52Locations
Source ClinicalTrials.gov
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