Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT04666155

MOWOOT Device Treatment for Adults With Chronic Constipation

Sponsor: usMIMA S.L.

View on ClinicalTrials.gov

Summary

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-04-25

Completion Date

2026-05-01

Last Updated

2026-01-22

Healthy Volunteers

Conditions

Constipation - Functional Constipation-predominant Irritable Bowel Syndrome Constipation Chronic Idiopathic Constipation; Neurogenic Constipation

Interventions

DEVICE

Intermittent Colonic Exoperistalsis with MOWOOT device

Patients under the experimental arm of the study should place the belt of the Mowoot device on the abdomen and use it for 20 minutes every day for 12 weeks. They should continue with their individualized standard of care againts constipation for the first 4 weeks. During the following 8 weeks of the interventional period of 12weeks, their use of SocTAI will be considered "rescue intervention". The 8weeks following the 12weeks of intervention, they can keep on using ICE device.or SocTAI or both.

DEVICE

Standard of care with Trans-Anal Irrigation

Patients under the active comparator arm of the study should continue with their individualized standard of care againts constipation for the 12weeks of intervention. The following 8 weeks they can keep on using SocTAI or ICE device or both.

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

Locations (3)

University Hospital of North Durham, NHS Foundation Trust

Durham, County Durham and Darlington, United Kingdom

University Hospital of North Tees, North Tees & Hartlepool NHS Foundation Trust

Hardwick, United Kingdom

The Newcastle Upon Tune Hospitals NHS Foundation Trust.

Newcastle upon Tyne, United Kingdom