MowOot and Trans-anal Irrigation fOr coNstipation
ConditionConstipation Chronic Idiopathic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorusMIMA S.L.
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- ICE Treatment
- TAI Standard-of-Care Treatment
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov