Treatment for adults with chronic constipation using the MOWOOT device
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.
This study is testing a new device called MOWOOT to see if it can help adults with chronic constipation feel better compared to the standard treatment they currently use.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | usMIMA S.L. Industry-sponsored |
| Locations | 1 site (Durham, County Durham and Darlington) |
| Trial ID | NCT04666155 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of the MOWOOT device, which utilizes Intermittent Colonic Exoperistalsis (ICE) treatment, compared to the standard care of trans-anal irrigation (TAI) for adults suffering from chronic constipation. The study will assess both clinical effectiveness through various quantitative and qualitative measures and economic outcomes to determine cost-effectiveness. Participants will be monitored for improvements in their symptoms and overall quality of life related to constipation. The trial will include adults aged 18 and older who have been experiencing chronic constipation symptoms for at least three months.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have chronic constipation symptoms and have been using trans-anal irrigation for at least three months.
Not a fit: Patients with irritable bowel syndrome with diarrhea or inflammatory bowel disease may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for managing chronic constipation, improving patients' quality of life.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in treating chronic constipation with device-assisted methods.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Durham, County Durham and Darlington
- University Hospital of North Durham, NHS Foundation Trust — Durham, County Durham and Darlington, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Immaculada Herrero, PhD
- Email: ihf@mowoot.com
- Phone: +34935106653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.