Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • ICE Treatment

    Device

    Each patient in the Experimental ICE Group will receive one Intermittent Colonic Exoperistalsis (ICE) treatment session lasting 20 minutes. These sessions will be conducted at least once per day, every day at the same hour, for a total duration of 12 weeks. The ICE treatment involves using the MOWOOT medical device designed to alleviate chronic constipation by stimulating colonic peristalsis.

  • TAI Standard-of-Care Treatment

    Procedure/Surgery

    Each patient in the Control TAI Group will follow the usual Trans-Anal Irrigation (TAI) standard-of-care treatment. This involves the regular use of TAI procedures as prescribed by healthcare professionals for the intervention period of 12 weeks. The TAI treatment is a well-established method for managing chronic constipation by mechanically clearing the bowel.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Experimental ICE GroupExperimental treatment 1 intervention
Group B: Control TAI GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Satisfaction with Daily Quality of Life Related to Bowel Management

Assessed by the Bothersome Scale (a Likert scale) where 0 is 'not at all' and 10 is 'a great deal,' with higher scores indicating a worse outcome

Time frame
12 weeks

Secondary outcomes

1

Changes in Quality of Life According to PAC-QOL Score

Assessed by the PAC-QOL (Patient Assessment of Constipation Quality of Life) scale, where higher scores indicate a worse quality of life.

Time frame
12 weeks
2

Changes in Constipation Symptoms According to PAC-SYM Score

Measured using the PAC-SYM (Patient Assessment of Constipation Symptoms) scale, with higher scores reflecting more severe constipation symptoms

Time frame
12 weeks
3

Changes in Constipation Severity According to CCCS

Evaluated by the CCCS (Constipation Clinical Severity Scale), where higher scores denote greater severity of constipation

Time frame
12 weeks
4

Change in Time Spent in Bowel Management

Measured in minutes per day, data from bowel diaries.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

usMIMA S.L.

Lead sponsor

Source ClinicalTrials.gov
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