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New treatment option for Constipation Chronic Idiopathic
Official title MowOot and Trans-anal Irrigation fOr coNstipation
ClinicalTrials.gov ID: NCT06833684
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Bothered by their constipation
- Failed biofeedback (in absence of outlet problems)
- In waiting list to use TAI
You likely can't join if
- 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
See the full eligibility criteria
- 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...
- Bothered by their constipation
- Failed biofeedback (in absence of outlet problems)
- In waiting list to use TAI
- Able to undertake the treatment with the MOWOOT device or TAI themselves, or with a carer willing to do it
- Able to understand the study requirements
- Able to understand written and spoken English (due to questionnaire validity)
- Able and willing to provide written informed consent to participate
- 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 treatment clinical trial or less than 2 months from participation in a previous treatment clinical trial
- Planned surgery\ if it might be within trial dates (\ minor surgery not affecting adherence to treatment is allowed)
The study team makes the final eligibility decision.
Where it's taking place
- London, London, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.