MowOot and Trans-anal Irrigation fOr coNstipation

NCT06833684 | Recruiting

• 1 other identifier: MOW-08-2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

constipation; transit problems; Trans-Anal Irrigation; Intermittent Colonic Exoperistalsis

Outcome Measures

Primary Outcomes (1)

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

  Assessed by the Bothersome Scale (a Likert scale) where 0 is 'not at all' and 10 is 'a great deal,' with higher scores indicating a worse outcome

  12 weeks

Secondary Outcomes (7)

• Changes in Quality of Life According to PAC-QOL Score

  12 weeks

• Changes in Constipation Symptoms According to PAC-SYM Score

  12 weeks

• Changes in Constipation Severity According to CCCS

  12 weeks

• Change in Time Spent in Bowel Management

  12 weeks

• Change in Time Spent in Evacuation

  12 weeks

Study Arms (2)

Experimental ICE Group

EXPERIMENTAL

Each patient will receive 1 ICE treatment of 20 minutes at least once per day, every day at the same hour, during the intervention period of 12 weeks.

Device: ICE Treatment

Control TAI Group

ACTIVE COMPARATOR

Each patient will follow the usual TAI standard-of-care treatment for the intervention period of 12 weeks.

Procedure: TAI Standard-of-Care Treatment

Interventions

ICE Treatment DEVICE

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.

Experimental ICE Group

TAI Standard-of-Care Treatment PROCEDURE

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.

Control TAI Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Able and willing to provide written informed consent to participate

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• usMIMA S.L.: lead

Study Sites (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, NW10 7NS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gregory Thomas, MD, PhD

  The Sir Alan Parks Physiology & Pelvic Floor Biofeedback Unit | Central Middlesex Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Immaculada Herrero-Fresneda, PhD

CONTACT

+34 935106653; ihf@mowoot.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study, meaning there is no masking. Both the participants and the researchers are aware of the treatment being administered. This approach is necessary due to the nature of the intervention, which makes blinding impractical.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, open-labelled, longitudinal, controlled study, with two treatment groups, performed at one single centre. For both groups, patients will be their own control in the pre and post analysis of primary and secondary outcomes.

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 19, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)