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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qufora QNova | Experimental |
| |
| Qufora Irrisedo Klick | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transanal irrigation | Device | Transanal irrigation by use of irrigation devices |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bowel Irrigation Questionnaire (BIQ) 4-point ordinal scale | Participant experience with device (0: strongly disagree, 4: strongly agree) | Week 4, 10, 26, and 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Diary | Bowel irrigation frequency (times per week) | Week 10, 26, and 52 |
| Patient Diary | Bowel irrigation volume (in ml) | Week 10, 26, and 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haya N.H. Pedersen | Contact | +45 31394941 | hap@qufora.com |
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| ID | Term |
|---|---|
| D004688 | Encopresis |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
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Post-market, exploratory, randomised, parallel, open-label
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| Cleveland Clinic Constipation Score (CCCS) | Constipation severity (Higher scores indicate worse constipation symptoms; score range: 0-30) | 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) | 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) | Week 0, 4, 10, 26, and 52 |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |