Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06833684

MowOot and Trans-anal Irrigation fOr coNstipation

Sponsor: usMIMA S.L.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-06-25

Completion Date

2026-09-01

Last Updated

2026-01-22

Healthy Volunteers

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.

Inclusion Criteria: 1. Adult people (18 yo or older) of any gender 2. 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. 3. Bothered by their constipation 4. Failed biofeedback (in absence of outlet problems) 5. In waiting list to use TAI 6. Able to undertake the treatment with the MOWOOT device or TAI themselves, or with a carer willing to do it 7. Able to understand the study requirements 8. Able to understand written and spoken English (due to questionnaire validity) 9. Able and willing to provide written informed consent to participate Exclusion Criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply: Disease phenotype exclusion criteria: * Irritable Bowel Syndrome with Diarrhoea (IBS-D) or alternating constipation and diarrhoea (IBSmix): (not due to laxative use) * Inflammatory Bowel Disease (IBD) * Significant outlet problem * Trapping rectocele * Intra anal rectal intussusception * External rectal prolapse Device-related exclusion criteria: * Abdominal perimeter ≤65cm or ≥130cm * Unable to independently use the MOWOOT technology, unless a carer is available daily to assist Other medical conditions, medications and contraindications: * Pregnancy or attempt to become pregnant in the next 6 months. * Previous large bowel resection * Active anorexia or bulimia * Active abdominal cancer * Large inguinal or umbilical hernia * Recent abdominal scars, abdominal wounds or skin disorders that may make abdominal massage uncomfortable * Any condition that contraindicates abdominal massage. * Significant abdominal pain * Participation in another parallel interventional clinical trial or less than 2 months from participation in a previous interventional clinical trial * Planned surgery\* if it might be within trial dates (\* minor surgery not affecting adherence to treatment is allowed)

Locations (1)

The Sir Alan Parks Physiology & Pelvic Floor Biofeedback Unit., Central Hospital, Department of Physiology, St Mark's Hospital, The National Bowel Hospital

London, London, United Kingdom