MowOot and Trans-anal Irrigation fOr coNstipation (NCT06833684) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares a device called MowOot with trans-anal irrigation for chronic idiopathic constipation — can you explain how each of these works and whether either one might be a reasonable option for my specific situation?
2Since this trial is listed as 'Phase NA,' it sounds like it's comparing two existing treatments rather than testing something brand new — does that change the safety picture compared to a typical drug trial, and what risks should I still be aware of?
3The main thing being measured is satisfaction with daily quality of life related to bowel management — how would that be tracked, and would I need to keep a diary or come in for regular assessments that might be hard to fit around work or family life?
4Before considering a trial like this, should I try any standard treatments for chronic idiopathic constipation first, or have I already exhausted the options that would typically come before interventions like trans-anal irrigation?
5If I enrol and find that one of the two approaches isn't working well for me, would I have the option to switch or withdraw from the trial without it affecting the rest of my care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Satisfaction with Daily Quality of Life Related to Bowel Management