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MowOot and Trans-anal Irrigation fOr coNstipation

NCT06833684 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-22

No results posted yet for this study

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.

Conditions

  • Constipation Chronic Idiopathic

Interventions

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.

Sponsors & Collaborators

  • usMIMA S.L.

    lead INDUSTRY

Principal Investigators

  • Gregory Thomas, MD, PhD · The Sir Alan Parks Physiology & Pelvic Floor Biofeedback Unit | Central Middlesex Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-25
Primary Completion
2026-07-31
Completion
2026-09-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06833684 on ClinicalTrials.gov