MOWOOT Device Treatment for Adults with Chronic Constipation
Research type
Research Study
Full 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
IRAS ID
323008
Contact name
Yan Yiannakou
Contact email
Sponsor organisation
USMIMA S.L.
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 15 days
Research summary
Constipation is a common condition which can affect people of all ages. People with constipation are not passing stools regularly or are unable to completely empty their bowel. In England, on average more than 200 people a day are admitted to hospital due to constipation.
Advice on diet and lifestyle is offered as an initial treatment for constipation. Where symptoms persist, laxatives are recommended. If symptoms are not relieved with laxatives, invasive treatment such as rectal irrigation may be considered. Trans-anal irrigation therapy (TAI) is a type of colonic irrigation which is self-administered by the patient at home. TAI therapy has been proved to be safe although discomfort and other complications have been reported.
One possible alternative to TAI is abdominal massage, which has been shown to reduce the symptoms of constipation, facilitating the passing of softer and more frequent stools. However, this type of massage is difficult to self-administer. This was the rationale for developing the wearable medical device, MOWOOT, which automatically applies intermittent colonic exoperistalsis (ICE) similar to abdominal massage. It is currently used in over 40 hospitals and assisted living facilities in Europe.
The main objective of our randomised controlled trial is to compare constipation related quality of life between participants using ICE and those using TAI. We will also look at constipation-related symptoms and compare the costs of the treatments between the two groups. The study will recruit in total 86 adults who have experienced constipation symptoms for at least 3 months. Each participant will be in the study for 22 weeks and attend 4 study visits. All participants will have the opportunity to use the MOWOOT device during the study.
The study will run from November 2023 to April 2025 at the University Hospital of North Durham and is funded by USMIMA S.L. (Spain).
REC name
London - Queen Square Research Ethics Committee
REC reference
23/LO/0949
Date of REC Opinion
21 Dec 2023
REC opinion
Further Information Favourable Opinion