MOWOOT Device Treatment for Adults With Chronic Constipation

Exclusion Criteria

• •1. Irritable Bowel Syndrome with Diarrhoea (IBS-D) or alternating constipation and diarrhoea (IBSmix): (not due to laxative use)
• •2. Inflammatory Bowel Disease (IBD)
• •3. Abdominal perimeter ≤65cm or ≥130cm
• •4. Unable to independently use the MOWOOT or TAI technology, unless a carer is available daily to assist
• •Other medical conditions, medications and contraindications:
• •5. Previous large bowel resection
• •6. The presence of a stoma
• •7. External rectal prolapse
• •8. Active anorexia or bulimia
• •9. Active abdominal cancer
• •10. Large inguinal or umbilical hernia
• •11. Recent abdominal scars, abdominal wounds or skin disorders that may make abdominal massage uncomfortable
• •12. Pregnancy or attempt to become pregnant in the next 6 months
• •13. Use of strong opioids\*
• •14. Use of antidepressants, bladder stabilisers or any other medication inducing, or treating, constipation unless used at a stable dose for at least 4 weeks before Screening Visit (this excludes laxatives which may be used as required up to three days before the screening visit)
• •15. Subjects already undertaking or have undertaken abdominal massage unless they underwent a previous washout period of at least 2 months
• •16. Participation in another parallel interventional clinical trial or less than 2 months from participation in a previous interventional clinical trial
• •17. Planned surgery for constipation if it might be within trial dates