MOWOOT versus trans-anal irrigation for chronic constipation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.