MOWOOT Device Treatment for Adults With Chronic Constipation

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.

The RCT will assess clinical effectiveness by means of quantitative and qualitative variables, and the cost effectiveness by means of economic outcomes.

Inclusion Criteria:

1. Any gender 18 years or older
2. 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
3. Bothered by their constipation
4. PAC-QOL ≥1.8
5. Using TAI for at least 3 months
6. Able to undertake the treatment with TAI or with the device themselves or with a carer willing to do it
7. Able to understand the study requirements
8. Able to understand written and spoken English (due to questionnaire validity)
9. Able and willing to provide written informed consent to participate

Exclusion Criteria:

Disease phenotype 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)

   Device-related exclusion criteria:

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