MOWOOT versus trans-anal irrigation for chronic constipation
Intermittent Colonic Exoperistalsis Treatment With MOWOOT Medical Device to Treat Chronic Constipation in Adult Patients Waiting for Using Trans-Anal Irrigation: A Pilot Study
This project will test whether daily Intermittent Colonic Exoperistalsis (ICE) with the MOWOOT device improves bowel management for adults with refractory chronic constipation who are waiting for trans-anal irrigation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | usMIMA S.L. Industry-sponsored |
| Locations | 1 site (London, London) |
| Trial ID | NCT06833684 on ClinicalTrials.gov |
What this trial studies
This is a prospective, open-label, single-center, controlled study comparing daily ICE using the MOWOOT device to standard trans-anal irrigation (TAI) care over 12 weeks. The experimental group will receive one 20-minute ICE session each day at a consistent time for 12 weeks, while the control group will continue usual TAI standard-of-care for 12 weeks. Participants and clinicians will discuss both options and participants may choose their treatment, with healthcare professionals advising based on individual needs. Primary outcomes focus on change in satisfaction with daily bowel management (Bothersome Likert scale), with secondary measures including PAC-QOL, constipation symptoms, and hospital economic impact.
Who should consider this trial
Good fit: Adults (18+) with refractory chronic idiopathic constipation who are on a waiting list for TAI, have failed biofeedback (when outlet problems are absent), are bothered by their constipation, and can use the device themselves or with a carer and understand English and study requirements are ideal candidates.
Not a fit: Patients with significant outlet obstruction or other non-idiopathic causes of constipation, those unable to use the MOWOOT device or TAI, or those who cannot comply with study procedures or English-language questionnaires may not receive benefit from this intervention.
Why it matters
Potential benefit: If successful, ICE with the MOWOOT device could improve patient satisfaction and reduce constipation symptoms as a non-invasive, at-home alternative to trans-anal irrigation.
How similar studies have performed: Trans-anal irrigation is an established bowel management option and preliminary studies of external abdominal stimulation devices like MOWOOT have shown promising symptom improvements, but randomized comparative evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
London, London
- 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 (Recruiting)
Study contacts
- Principal investigator: Gregory Thomas, MD, PhD — The Sir Alan Parks Physiology & Pelvic Floor Biofeedback Unit | Central Middlesex Hospital
- Study coordinator: Immaculada Herrero-Fresneda, PhD
- Email: ihf@mowoot.com
- Phone: +34 935106653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.