Constipation Chronic IdiopathicMOTIONNCT06833684
MowOot and Trans-anal Irrigation fOr coNstipation
A study testing ICE Treatment and TAI Standard-of-Care Treatment in people with Constipation Chronic Idiopathic, run by usMIMA S.L. at 1 site in United Kingdom.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation Chronic Idiopathic
- What is being tested?
- ICE Treatment and TAI Standard-of-Care Treatment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Jun 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- 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
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- 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
Who cannot join
- 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
Show all 22Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
The Sir Alan Parks Physiology & Pelvic Floor Biofeedback Unit., Central Hospital, Department of Physiology, St Mark's Hospital, The National Bowel Hospital
London, London, NW10 7NS
Alex Bortolotti, 020 8963 7189, enquiries@trustplus.co.uk
Tatenda Marunda
About this study
Official title: Intermittent Colonic Exoperistalsis Treatment With MOWOOT Medical Device to Treat Chronic Constipation in Adult Patients Waiting for Using Trans-Anal Irrigation: A Pilot Study
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.
Read the detailed description
This study is a prospective, open-labelled, longitudinal, controlled trial conducted at a single center. It aims to assess the suitability of Intermittent Colonic Exoperistalsis (ICE) treatment for bowel management in 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 includes two treatment groups:
Experimental ICE Group: Participants will receive one ICE treatment session lasting 20 minutes daily, at the same hour, for 12 weeks.
Control TAI Group: Participants will follow the usual TAI standard-of-care treatment for 12 weeks.
Participants will be given the option to choose between the ICE treatment and the TAI treatment after both options are explained to them. Healthcare professionals will recommend the most suitable treatment based on individual patient needs, but the final decision will rest with the patients.
The primary objective is to evaluate the change in satisfaction with daily quality of life related to bowel management, measured by a Likert scale (Bothersome scale). Secondary objectives include assessing the efficacy of the ICE treatment on chronic constipation, both qualitatively and quantitatively, and evaluating the economic impact from the hospital's perspective.
Secondary outcomes will be measured through various patient-reported and health professional-reported metrics, including changes in quality of life (PAC-QOL), constipation symptoms (PAC-SYM), constipation severity (CCCS), time spent in bowel management and evacuation, use of other treatments, number of consultations and hospital admissions, productivity, acceptability and ease of use of the ICE treatment, reported problems, compliance, adherence, and persistence in treatment. Health professional outcomes will include time spent per visit, total time spent until independent use of MOWOOT, ease of patient management, and patient treatment preferences.
- Conditions
- Constipation Chronic Idiopathic
- Being tested
- ICE Treatment, TAI Standard-of-Care Treatment
- Keywords
- constipation, transit problems, Trans-Anal Irrigation, Intermittent Colonic Exoperistalsis
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICE TreatmentDevice
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 TreatmentProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental ICE Group | Experimental | Each patient will receive 1 ICE treatment of 20 minutes at least once per day, every day at the same hour, during the intervention period of 12 weeks. Receives: Device: ICE Treatment |
| Control TAI Group | Active comparator | Each patient will follow the usual TAI standard-of-care treatment for the intervention period of 12 weeks. Receives: Procedure: TAI Standard-of-Care Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (7)
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.
Measured: 12 weeks
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
Measured: 12 weeks
Changes in Constipation Severity According to CCCS
Evaluated by the CCCS (Constipation Clinical Severity Scale), where higher scores denote greater severity of constipation
Measured: 12 weeks
Change in Time Spent in Bowel Management
Measured in minutes per day, data from bowel diaries.
Measured: 12 weeks
Change in Time Spent in Evacuation
Measured in minutes per day, data from bowel diaries.
Measured: 12 weeks
Change in Use of Other Treatments (e.g., Laxatives, Suppositories)
Data from patient surveys.
Measured: 12 weeks
Change in Number of Consultations to Primary Care (GP, Nurse)
Data from patient surveys.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start25 Jun 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation Chronic IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, open-labelled, longitudinal, controlled study, with two treatment groups, performed at one single centre. For both groups, patients will be their own control in the pre and post analysis of primary and secondary outcomes.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- usMIMA S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory Thomas, MD, PhD, Principal investigator, The Sir Alan Parks Physiology & Pelvic Floor Biofeedback Unit | Central Middlesex Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833684
- Sponsor's protocol ID
- MOW-08-2024
- Acronym
- MOTION
- Status last verified
- Jan 2026
- First submitted
- 12 Feb 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Colonic Exoperistalsis Treatment With MOWOOT Medical Device to Treat Chronic Constipation in Adult Patients Waiting for Using Trans-Anal Irrigation: A Pilot Study
- ClinicalTrials.gov ID
- NCT06833684
- Acronym / sponsor ID
- MOTION / MOW-08-2024
- Conditions
- Constipation Chronic Idiopathic
- Keywords
- constipation, transit problems, Trans-Anal Irrigation, Intermittent Colonic Exoperistalsis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- usMIMA S.L.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a prospective, open-labelled, longitudinal, controlled trial conducted at a single center. It aims to assess the suitability of Intermittent Colonic Exoperistalsis (ICE) treatment for bowel management in 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 includes two treatment groups:
Experimental ICE Group: Participants will receive one ICE treatment session lasting 20 minutes daily, at the same hour, for 12 weeks.
Control TAI Group: Participants will follow the usual TAI standard-of-care treatment for 12 weeks.
Participants will be given the option to choose between the ICE treatment and the TAI treatment after both options are explained to them. Healthcare professionals will recommend the most suitable treatment based on individual patient needs, but the final decision will rest with the patients.
The primary objective is to evaluate the change in satisfaction with daily quality of life related to bowel management, measured by a Likert scale (Bothersome scale). Secondary objectives include assessing the efficacy of the ICE treatment on chronic constipation, both qualitatively and quantitatively, and evaluating the economic impact from the hospital's perspective.
Secondary outcomes will be measured through various patient-reported and health professional-reported metrics, including changes in quality of life (PAC-QOL), constipation symptoms (PAC-SYM), constipation severity (CCCS), time spent in bowel management and evacuation, use of other treatments, number of consultations and hospital admissions, productivity, acceptability and ease of use of the ICE treatment, reported problems, compliance, adherence, and persistence in treatment. Health professional outcomes will include time spent per visit, total time spent until independent use of MOWOOT, ease of patient management, and patient treatment preferences.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, open-labelled, longitudinal, controlled study, with two treatment groups, performed at one single centre. For both groups, patients will be their own control in the pre and post analysis of primary and secondary outcomes.
| Arm | Type | Receives |
|---|---|---|
| Experimental ICE Group | Experimental | Device: ICE TreatmentEach patient will receive 1 ICE treatment of 20 minutes at least once per day, every day at the same hour, during the intervention period of 12 weeks. |
| Control TAI Group | Active comparator | Procedure: TAI Standard-of-Care TreatmentEach patient will follow the usual TAI standard-of-care treatment for the intervention period of 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
- In waiting list to use TAI
Key exclusion criteria (22 listed)
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICE TreatmentEach 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. | Device | Experimental ICE Group |
| TAI Standard-of-Care TreatmentEach 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. | Procedure or surgery | Control TAI Group |
Primary outcome
Change in Satisfaction with Daily Quality of Life Related to Bowel Management
Time frame: 12 weeks
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
7 secondary outcomes
Changes in Quality of Life According to PAC-QOL Score
Time frame: 12 weeks
Changes in Constipation Symptoms According to PAC-SYM Score
Time frame: 12 weeks
Changes in Constipation Severity According to CCCS
Time frame: 12 weeks
Change in Time Spent in Bowel Management
Time frame: 12 weeks
Change in Time Spent in Evacuation
Time frame: 12 weeks
Change in Use of Other Treatments (e.g., Laxatives, Suppositories)
Time frame: 12 weeks
Change in Number of Consultations to Primary Care (GP, Nurse)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gregory Thomas, MD, PhD principal investigator
The Sir Alan Parks Physiology & Pelvic Floor Biofeedback Unit | Central Middlesex Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICE Treatment and TAI Standard-of-Care Treatment in people with Constipation Chronic Idiopathic, run by usMIMA S.L. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Immaculada Herrero-Fresneda, PhD (+34 935106653, ihf@mowoot.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Satisfaction with Daily Quality of Life Related to Bowel Management (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.