Status:
RECRUITING
MOWOOT Device Treatment for Adults With Chronic Constipation
Lead Sponsor:
usMIMA S.L.
Collaborating Sponsors:
County Durham and Darlington NHS Foundation Trust
University of York
Conditions:
Constipation - Functional
Constipation-predominant Irritable Bowel Syndrome
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief 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 sta...
Detailed Description
The RCT will assess clinical effectiveness by means of quantitative and qualitative variables, and the cost effectiveness by means of economic outcomes.
Eligibility Criteria
Inclusion
- Any gender 18 years or older
- 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
- Bothered by their constipation
- PAC-QOL ≥1.8
- Using TAI for at least 3 months
- Able to undertake the treatment with TAI or with the device themselves or with a carer willing to do it
- Able to understand the study requirements
- Able to understand written and spoken English (due to questionnaire validity)
- Able and willing to provide written informed consent to participate
Exclusion
- Disease phenotype exclusion criteria:
- Irritable Bowel Syndrome with Diarrhoea (IBS-D) or alternating constipation and diarrhoea (IBSmix): (not due to laxative use)
- Inflammatory Bowel Disease (IBD)
- Device-related exclusion criteria:
- Abdominal perimeter ≤65cm or ≥130cm
- Unable to independently use the MOWOOT or TAI technology, unless a carer is available daily to assist
- Other medical conditions, medications and contraindications:
- Previous large bowel resection
- The presence of a stoma
- External rectal prolapse
- Active anorexia or bulimia
- Active abdominal cancer
- Large inguinal or umbilical hernia
- Recent abdominal scars, abdominal wounds or skin disorders that may make abdominal massage uncomfortable
- Pregnancy or attempt to become pregnant in the next 6 months
- Use of strong opioids\*
- 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)
- Subjects already undertaking or have undertaken abdominal massage unless they underwent a previous washout period of at least 2 months
- Participation in another parallel interventional clinical trial or less than 2 months from participation in a previous interventional clinical trial
- Planned surgery for constipation if it might be within trial dates
Key Trial Info
Start Date :
April 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT04666155
Start Date
April 25 2024
End Date
May 1 2026
Last Update
September 17 2025
Active Locations (3)
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1
University Hospital of North Durham, NHS Foundation Trust
Durham, County Durham and Darlington, United Kingdom, DH5TW
2
University Hospital of North Tees, North Tees & Hartlepool NHS Foundation Trust
Hardwick, United Kingdom
3
The Newcastle Upon Tune Hospitals NHS Foundation Trust.
Newcastle upon Tyne, United Kingdom