A Randomised Controlled Trial to Evaluate Effectiveness and Cost-Effectiveness of Intermittent Colonic Exoperistalsis Treatment With MOWOOT Medical Device in Adults With Chronic Constipation Using Trans-Anal Irrigation.
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.
• 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)
• Able and willing to provide written informed consent to participate