MOWOOT Device Treatment for Adults With Chronic Constipation (NCT04666155) | Clinical Trial Compass
CompletedNot Applicable
MOWOOT Device Treatment for Adults With Chronic Constipation
United Kingdom86 participantsStarted 2024-04-25
Plain-language summary
The primary objective is to compare the effectiveness of the experimental Intermittent Colonic Exoperistalsis (ICE) treatment with MOWOOT, with the active control of trans-anal irrigation (TAI) as standard-of-care. The secondary objectives are to further compare the ICE treatment with MOWOOT to the TAI standard-of-care clinically and economically.
Who can participate
Age range18 Years – 99 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Any gender 18 years or older
✓. Symptoms meeting the American College of Gastroenterology definition of chronic constipation: unsatisfactory defaecation characterized by infrequent stool, difficult stool passage or both for at least previous 3 months
✓. Bothered by their constipation
✓. PAC-QOL ≥1.8
✓. Using TAI for at least 3 months
✓. Able to undertake the treatment with TAI or with the device themselves or with a carer willing to do it
✓. Able to understand the study requirements
✓. Able to understand written and spoken English (due to questionnaire validity)
Exclusion criteria
✕. Irritable Bowel Syndrome with Diarrhoea (IBS-D) or alternating constipation and diarrhoea (IBSmix): (not due to laxative use)
✕. Inflammatory Bowel Disease (IBD)
✕. Abdominal perimeter ≤65cm or ≥130cm
✕. Unable to independently use the MOWOOT or TAI technology, unless a carer is available daily to assist
✕. Previous large bowel resection
✕
What they're measuring
1
Changes in quality of life (PAC-QoL)
Timeframe: End of treatment (week 14, last week of treatment) - Baseline (before treatment)