The MOTION study: MowOot and Trans-anal Irrigation fOr coNstipation
Research type
Research Study
Full title
INTERMITTENT COLONIC EXOPERISTALSIS TREATMENT WITH MOWOOT MEDICAL DEVICE TO TREAT CHRONIC CONSTIPATION IN ADULTS PATIENTS WAITING FOR USING TRANS-ANAL IRRIGATION. A PILOT STUDY.
IRAS ID
353188
Contact name
Gregory T Thomas
Contact email
Sponsor organisation
USMIMA S.L.
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 28 days
Research summary
This study is a prospective, open-labelled, longitudinal, controlled trial conducted at a single center. It aims to assess the suitability of Intermittent Colonic Exoperistalsis (ICE) treatment for bowel management in adults with refractory chronic constipation who are awaiting trans-anal irrigation (TAI). The ICE treatment will be applied using the MOWOOT device (USMIMA). The study includes two treatment groups:
Experimental ICE Group: Participants will receive one ICE treatment session lasting 20 minutes daily for 12 weeks.
Control TAI Group: Participants will follow the usual TAI standard-of-care treatment for 12 weeks.
The primary objective is to evaluate the change in satisfaction with daily quality of life related to bowel management, measured by a Likert scale (Bothersome scale).
Secondary outcomes will be measured through various patient-reported and health professional-reported metrics, including changes in quality of life (PAC-QOL), constipation symptoms (PAC-SYM), constipation severity (CCCS), time spent in bowel management and evacuation, use of other treatments, number of consultations and hospital admissions, productivity, acceptability and ease of use of the ICE treatment, reported problems, compliance, adherence, and persistence in treatment. Health professional outcomes will include time spent per visit, total time spent until independent use of MOWOOT, ease of patient management, and patient treatment preferences.
REC name
North of Scotland Research Ethics Committee 1
REC reference
25/NS/0028
Date of REC Opinion
28 Mar 2025
REC opinion
Favourable Opinion