RecruitingNot Applicable

MowOot and Trans-anal Irrigation fOr coNstipation

United Kingdom40 participantsStarted 2025-06-25

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adult people (18 yo or older) of any gender
✓. Attending their pre-scheduled on-site visit to the site (The Sir Alan Parks Physiology \& Pelvic Floor Biofeedback Unit \| Central Middlesex Hospital) due to constipation (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
✓. Failed biofeedback (in absence of outlet problems)
✓. In waiting list to use TAI
✓. Able to undertake the treatment with the MOWOOT device or TAI 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)

What they're measuring

Change in Satisfaction with Daily Quality of Life Related to Bowel Management

Timeframe: 12 weeks

Trial details

NCT IDNCT06833684

SponsorusMIMA S.L.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-31

Contact for this trial

Immaculada Herrero-Fresneda, PhD

+34 935106653 ihf@mowoot.com

View on ClinicalTrials.gov More Constipation Chronic Idiopathic trials