Actively Recruiting
MowOot and Trans-anal Irrigation fOr coNstipation
Led by usMIMA S.L. · Updated on 2026-01-22
40
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
MowOot and Trans-anal Irrigation fOr coNstipation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Attending a scheduled visit for constipation at the specified hospital unit
- Experiencing chronic constipation symptoms for at least 3 months as defined by the American College of Gastroenterology
- Feeling bothered by their constipation
- Have failed biofeedback therapy (if no outlet problems present)
- On a waiting list to start trans-anal irrigation (TAI)
- Able to perform treatment with the MOWOOT device or TAI themselves or have a carer willing to assist
- Able to understand study requirements
- Able to read and understand written and spoken English
- Able and willing to give written informed consent
You will not qualify if you...
- Diagnosis of irritable bowel syndrome with diarrhea or alternating constipation and diarrhea (not caused by laxatives)
- Diagnosis of inflammatory bowel disease
- Significant outlet problems such as trapping rectocele, intra-anal rectal intussusception, or external rectal prolapse
- Abdominal perimeter less than 65 cm or greater than 130 cm
- Unable to use the MOWOOT device independently without daily carer assistance
- Pregnancy or planning pregnancy in the next 6 months
- Previous large bowel surgery
- Active anorexia or bulimia
- Active abdominal cancer
- Large inguinal or umbilical hernia
- Recent abdominal scars, wounds, or skin conditions making abdominal massage uncomfortable
- Any condition that contraindicates abdominal massage
- Significant abdominal pain
- Participation in another interventional clinical trial currently or within the last 2 months
- Planned surgery during the trial period (minor surgery not affecting treatment adherence allowed)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
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, NW10 7NS
Actively Recruiting
Research Team
I
Immaculada Herrero-Fresneda, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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