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โ† Trials
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MowOot and Trans-anal Irrigation fOr coNstipation

RecruitingNAAges 18 Years - anyAllusMIMA S.L.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค65cm or โ‰ฅ130cm * 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)
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What it tests

  • ICE Treatment
  • TAI Standard-of-Care Treatment
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Where

1 site
The Sir Alan Parks Physiology & Pelvic Floor Biofeedback Unit., Central Hospital, Department of Physiology, St Mark's Hospital, The National Bowel Hospital
London, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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