MOWOOT Device Treatment for Adults with Chronic Constipation

Launched by USMIMA S.L. · Dec 7, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called the MOWOOT device for adults who suffer from chronic constipation. The main goal is to see how well this new treatment works compared to a standard method called trans-anal irrigation (TAI), which helps with bowel movements. The trial aims to measure both the effectiveness of the MOWOOT device and how it compares to TAI in terms of cost and overall patient experience.

To be eligible for this trial, participants need to be at least 18 years old and have experienced chronic constipation symptoms for at least three months. They should also be bothered by their constipation and have been using TAI for at least three months. Participants will need to be able to understand the study and provide consent to join. If you or someone you know is dealing with chronic constipation and fits these criteria, this trial might offer a new treatment option. Participants will receive the MOWOOT device and will be monitored throughout the study to evaluate its effectiveness.

Gender

ALL

Eligibility 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