Chronic Constipation, Faecal Incontinence
Conditions
Brief 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.
Interventions
DEVICETransanal irrigation
Transanal irrigation by use of irrigation devices
Sponsors
Qufora A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Post-market, exploratory, randomised, parallel, open-label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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) * Ability to understand and provide written, informed consent prior to any investigation-specific procedures
Exclusion criteria
* 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) * Physical disability that affects the ability to independently use the irrigation device * Intermittent use of opioids inducing chronic constipation * Patulous anus * Participation in research conflicting with the current investigation * Physical or mental conditions affecting the ability to comply with the clinical investigation plan * Pregnancy or plans to become pregnant during the investigation period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel Irrigation Questionnaire (BIQ) 4-point ordinal scale | Week 4, 10, 26, and 52 | Participant experience with device (0: strongly disagree, 4: strongly agree) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Diary | Week 10, 26, and 52 | Bowel irrigation frequency (times per week) |
| Cleveland Clinic Constipation Score (CCCS) | Week 0, 4, 10, 26, and 52 | Constipation severity (Higher scores indicate worse constipation symptoms; score range: 0-30) |
| St Mark's Incontinence Score (SMIS | Week 0, 4, 10, 26, and 52 | Fecal incontinence severity (Higher scores indicate worse incontinence symptoms; score range: 0-24) |
| The 5-level EQ-5D (EQ-5D-5L) index score | Week 0, 4, 10, 26, and 52 | General health-related quality of life (measure across five dimensions; higher levels indicate greater health impairment) |
Contacts
CONTACTHaya N.H. Pedersen
Outcome results
None listed