NCT06833684

MowOot and Trans-anal Irrigation fOr coNstipation

Intermittent Colonic Exoperistalsis Treatment With MOWOOT Medical Device to Treat Chronic Constipation in Adult Patients Waiting for Using Trans-Anal Irrigation: A Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: usMIMA S.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective, open-labelled, longitudinal, controlled study aims to evaluate the suitability of Intermittent Colonic Exoperistalsis (ICE) treatment for 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 involves two treatment groups: an experimental group receiving daily ICE treatments and a control group following standard TAI care. Participants will serve as their own controls in pre- and post-treatment analyses to assess changes in bowel management satisfaction and other outcomes.

Detailed description

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, at the same hour, for 12 weeks. Control TAI Group: Participants will follow the usual TAI standard-of-care treatment for 12 weeks. Participants will be given the option to choose between the ICE treatment and the TAI treatment after both options are explained to them. Healthcare professionals will recommend the most suitable treatment based on individual patient needs, but the final decision will rest with the patients. 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 objectives include assessing the efficacy of the ICE treatment on chronic constipation, both qualitatively and quantitatively, and evaluating the economic impact from the hospital's perspective. 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.

Conditions

• Constipation Chronic Idiopathic

Interventions

Type	Name	Description
DEVICE	ICE Treatment	Each patient in the Experimental ICE Group will receive one Intermittent Colonic Exoperistalsis (ICE) treatment session lasting 20 minutes. These sessions will be conducted at least once per day, every day at the same hour, for a total duration of 12 weeks. The ICE treatment involves using the MOWOOT medical device designed to alleviate chronic constipation by stimulating colonic peristalsis.
PROCEDURE	TAI Standard-of-Care Treatment	Each patient in the Control TAI Group will follow the usual Trans-Anal Irrigation (TAI) standard-of-care treatment. This involves the regular use of TAI procedures as prescribed by healthcare professionals for the intervention period of 12 weeks. The TAI treatment is a well-established method for managing chronic constipation by mechanically clearing the bowel.

Timeline

• Start date: 2025-06-25
• Primary completion: 2026-07-31
• Completion: 2026-09-01
• First posted: 2025-02-19
• Last updated: 2026-01-22

Locations

1 site across 1 country: United Kingdom