Constipation - FunctionalMOTACCNCT04666155

MOWOOT Device Treatment for Adults With Chronic Constipation

A study testing Intermittent Colonic Exoperistalsis with MOWOOT device in people with Constipation - Functional and Constipation-predominant Irritable Bowel Syndrome, run by usMIMA S.L. at 3 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Constipation - Functional, Constipation-predominant Irritable Bowel Syndrome, Constipation Chronic Idiopathic
What is being tested?: Intermittent Colonic Exoperistalsis with MOWOOT device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 86 participants
Where: 3 sitesUnited Kingdom
Study dates: 25 Apr 2024to 29 Mar 2026
Phase: Interventional
Are there results?: None posted in the registry

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 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Any gender 18 years or older
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
PAC-QOL ≥1.8
Using TAI for at least 3 months
Able to undertake the treatment with TAI or with the device themselves or with a carer willing to do it

Show all 9Show fewer

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

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)
Device-related exclusion criteria:
Abdominal perimeter ≤65cm or ≥130cm
Unable to independently use the MOWOOT or TAI technology, unless a carer is available daily to assist

Show all 20Show fewer

Other medical conditions, medications and contraindications:
Previous large bowel resection
The presence of a stoma
External rectal prolapse
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
Pregnancy or attempt to become pregnant in the next 6 months
Use of strong opioids*
Use of antidepressants, bladder stabilisers or any other medication inducing, or treating, constipation unless used at a stable dose for at least 4 weeks before Screening Visit (this excludes laxatives which may be used as required up to three days before the screening visit)
Subjects already undertaking or have undertaken abdominal massage unless they underwent a previous washout period of at least 2 months
Participation in another parallel interventional clinical trial or less than 2 months from participation in a previous interventional clinical trial
Planned surgery for constipation if it might be within trial dates

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites

University Hospital of North Durham, NHS Foundation Trust
Durham, County Durham and Darlington, DH5TW
University Hospital of North Tees, North Tees & Hartlepool NHS Foundation Trust
Hardwick
The Newcastle Upon Tune Hospitals NHS Foundation Trust.
Newcastle upon Tyne

Other trials in United Kingdom

About this study

Official title: A Randomised Controlled Trial to Evaluate Effectiveness and Cost-Effectiveness of Intermittent Colonic Exoperistalsis Treatment With MOWOOT Medical Device in Adults With Chronic Constipation Using Trans-Anal Irrigation.

The primary objective is to compare the effectiveness of the experimental Intermittent Colonic Exoperistalsis (ICE) treatment with MOWOOT, with the active control of trans-anal irrigation (TAI) as standard-of-care. The secondary objectives are to further compare the ICE treatment with MOWOOT to the TAI standard-of-care clinically and economically.

Read the detailed description

The RCT will assess clinical effectiveness by means of quantitative and qualitative variables, and the cost effectiveness by means of economic outcomes.

Conditions: Constipation - Functional, Constipation-predominant Irritable Bowel Syndrome, Constipation Chronic Idiopathic, Constipation; Neurogenic, Constipation
Being tested: Intermittent Colonic Exoperistalsis with MOWOOT device, Standard of care with Trans-Anal Irrigation
Medical subject headings: Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intermittent Colonic Exoperistalsis with MOWOOT deviceDevice
Patients under the experimental arm of the study should place the belt of the Mowoot device on the abdomen and use it for 20 minutes every day for 12 weeks. They should continue with their individualized standard of care againts constipation for the first 4 weeks. During the following 8 weeks of the interventional period of 12weeks, their use of SocTAI will be considered "rescue intervention". The 8weeks following the 12weeks of intervention, they can keep on using ICE device.or SocTAI or both.
Standard of care with Trans-Anal IrrigationDevice
Patients under the active comparator arm of the study should continue with their individualized standard of care againts constipation for the 12weeks of intervention. The following 8 weeks they can keep on using SocTAI or ICE device or both.

Study groups in NCT04666155
Study group	Role	What they receive
Intermittent Colon Exoperistalsis (ICE)	Experimental	Intermittent Colon Exoperistalsis (ICE) Treatment with Mowoot device. 20min daily for 12 weeks Receives: Device: Intermittent Colonic Exoperistalsis with MOWOOT device; Device: Standard of care with Trans-Anal Irrigation
Standard-of-care with Trans-anal Irrigation (Soc TAI)	Active comparator	Standard-of-care with Trans-anal Irrigation (Soc TAI) for chronic constipation for 12 weeks. Receives: Device: Standard of care with Trans-Anal Irrigation

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in quality of life (PAC-QoL)
Semi-quantitative assessment of the changes in quality of life respect to chronic constipation, of patients using the ICE treatment with MOWOOT compared with patients under standard of care treatment. The measure is done according to PAC-QoL questionnaire.
Measured: End of treatment (week 14, last week of treatment) - Baseline (before treatment)

Secondary outcomes (21)

Frequency of use of TAI
How many days per week the patient has used TAI
Measured: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Frequency of use of ICE
How many days per week the patient has used ICE
Measured: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Changes in Constipation symptoms (PAC-SYM)
Semi-quantitative assessment of the changes in symptoms of constipation of patients using the ICE treatment with MOWOOT compared with patients under standard of care treatment. The measure is done according to PAC-SYM questionnaire.
Measured: 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment)
Changes in quality of life according to Euroqol ED5D5L
Semi-quantitative assessment of the changes in self-perceived quality of life according to the EQ-5D-5L instrument
Measured: 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment)
Changes in the number of days evacuation felt complete
Quantitative assessment of the change in the number of days per week evacuation felt complete at the end of the day
Measured: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Changes in the maximum number of consecutive days without complete bowel movements
Quantitative assessment of the change in the maximum number of consecutive days within the 2-week diary period without complete bowel movementscomplete at the end of the day
Measured: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Changes in the number of days with a normal stool
Quantitative assessment of the change in the number of days with a normal stool (Bristol Stool Scale 3-5) during the 2-week diary period
Measured: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Changes in the mean time spent in bowel management
Quantitative assessment of the change in the mean time spent in bowel management per week
Measured: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Changes in the mean time spent per evacuation
Quantitative assessment of the change in the mean time spent per evaquation
Measured: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Changes in the number of days with fecal incontinence
Quantitative assessment of the change in the number of days with fecal incontinence per week
Measured: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Changes in laxative use
Quantitative assessment of the change in the number of days per week taking laxatives
Measured: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Changes in the use of SoC TAI (HE outcome)
Quantitative assessment of the changes in number of people (%) who stop using TAI while using ICE with MOWOOT during the 12-week RCT period; and mean/median change in the use of TAI while using Mowoot during the 12-week RCT period
Measured: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Number of visits to GP and specialists (HE outcome)
Quantitative assessment of the changes in the direct medical healthcare costs due to constipation-related problems assessed as the number of visits to GP and specialists (in primary care centres, hospitals, or visits received at home) over the previous 8 weeks
Measured: 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment)
Number of visits to Accident & Emergency room (HE outcome)
Quantitative assessment of the changes in the direct medical healthcare costs due to constipation-related problems assessed as the number of visits to to Accident \& Emergency room (A\&E) over the previous 8 weeks
- Number of visits to GP and specialists (in primary care centres, hospitals, or visits received at home)
- Number of visits to Accident \& Emergency room (A\&E)
- Continence Service consultations (face-to-face visits and/or phone calls)
- Number of hospital admissions
- Days spent at hospital
- Use of relevant medications (including opioids, antidepressants, bladder stabilisers or any other medication inducing constipation) and supplies (diapers, protector sheets, suppositories and micro-enemas) during the 12-week RCT period; and mean/median change in the use of TAI while using Mowoot during the 12-week RCT period
Measured: 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment)
Continence Service consultations (HE outcome)
Quantitative assessment of the changes in the direct medical healthcare costs due to constipation-related problems assessed as the number of continence Service consultations (face-to-face visits and/or phone calls) over the previous 8 weeks
Measured: 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment)
Number of hospital admissions (HE outcome)
Quantitative assessment of the changes in the direct medical healthcare costs due to constipation-related problems assessed as the number of hospital admissions over the previous 8 weeks
Measured: 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment)
Days spent at hospital (HE outcome)
Quantitative assessment of the changes in the direct medical healthcare costs due to constipation-related problems assessed as the days spent at hospital over the previous 8 weeks
Measured: 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment)
Use of relevant medications (HE outcome)
Quantitative assessment of the changes in the direct medical healthcare costs due to constipation-related problems assessed as the use of relevant medications, including opioids, antidepressants, bladder stabilisers or any other medication inducing constipation, over the previous 8 weeks
Measured: 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment)
Use of relevant supplies (HE outcome)
Quantitative assessment of the changes in the direct medical healthcare costs due to constipation-related problems assessed as the use of relevant supplies (diapers, protector sheets, suppositories and micro-enemas), over the previous 8 weeks
Measured: 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment)
Incremental cost/effectiveness ratio (ICER) and Quality-Adjusted Life years (QALYS) (HE outcome)
Quantitative assessment of the of ICER and QALYS based on the health-related quality of life questionnaire EQ-5D-5L
Measured: EQ-5D-5L3 answered 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment)
Adverse events and Serious adverse events
Quantitative and qualitative assessment of adverse events (AEs) and serious adverse events (SAEs)
Measured: Evrey day during all the follow-up, from recruitment (visit 0, day 0) to the end of study (visit 3, day 154)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Apr 202429 Mar 2026

First posted14 Dec 2020
Study start25 Apr 2024
Primary completion29 Mar 2026
Study completion29 Mar 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Constipation - FunctionalStudies 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: Randomised
Intervention model: Parallel groups
Model description: Randomized controlled trial
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04666155
Sponsor's protocol ID: MOW-06-2023
Acronym: MOTACC
Status last verified: Jun 2026
First submitted: 7 Dec 2020
Last updated: 3 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ayas S, Leblebici B, Sozay S, Bayramoglu M, Niron EA. The effect of abdominal massage on bowel function in patients with spinal cord injury. Am J Phys Med Rehabil. 2006 Dec;85(12):951-5. doi: 10.1097/01.phm.0000247649.00219.c0.
PubMed 17117000
Diego MA, Field T. Moderate pressure massage elicits a parasympathetic nervous system response. Int J Neurosci. 2009;119(5):630-8. doi: 10.1080/00207450802329605.
PubMed 19283590
Sinclair M. The use of abdominal massage to treat chronic constipation. J Bodyw Mov Ther. 2011 Oct;15(4):436-45. doi: 10.1016/j.jbmt.2010.07.007. Epub 2010 Aug 25.
PubMed 21943617
Marquis P, De La Loge C, Dubois D, McDermott A, Chassany O. Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire. Scand J Gastroenterol. 2005 May;40(5):540-51. doi: 10.1080/00365520510012208.
PubMed 16036506
Frank L, Kleinman L, Farup C, Taylor L, Miner P Jr. Psychometric validation of a constipation symptom assessment questionnaire. Scand J Gastroenterol. 1999 Sep;34(9):870-7. doi: 10.1080/003655299750025327.
PubMed 10522604
Drossman DA, Hasler WL. Rome IV-Functional GI Disorders: Disorders of Gut-Brain Interaction. Gastroenterology. 2016 May;150(6):1257-61. doi: 10.1053/j.gastro.2016.03.035. No abstract available.
PubMed 27147121
Yiannakou Y, Tack J, Piessevaux H, Dubois D, Quigley EMM, Ke MY, Da Silva S, Joseph A, Kerstens R. The PAC-SYM questionnaire for chronic constipation: defining the minimal important difference. Aliment Pharmacol Ther. 2017 Dec;46(11-12):1103-1111. doi: 10.1111/apt.14349. Epub 2017 Oct 6.
PubMed 28983926
Forootan M, Bagheri N, Darvishi M. Chronic constipation: A review of literature. Medicine (Baltimore). 2018 May;97(20):e10631. doi: 10.1097/MD.0000000000010631.
PubMed 29768326
Lamas K, Lindholm L, Engstrom B, Jacobsson C. Abdominal massage for people with constipation: a cost utility analysis. J Adv Nurs. 2010 Aug;66(8):1719-29. doi: 10.1111/j.1365-2648.2010.05339.x. Epub 2010 Jun 16.
PubMed 20557387
McClurg D, Booth L, Herrero-Fresneda I. Safety and Efficacy of Intermittent Colonic Exoperistalsis Device to Treat Chronic Constipation: A Prospective Multicentric Clinical Trial. Clin Transl Gastroenterol. 2020 Dec;11(12):e00267. doi: 10.14309/ctg.0000000000000267.
PubMed 33512794
Bremer J, Bremer J, Konig M, Kossmehl P, Kurze I, Obereisenbuchner J, Weinschenk E, Herrero-Fresneda I. Intermittent colonic exoperistalsis for chronic constipation in spinal cord-injured individuals. A long-term structured patient feedback survey to evaluate home care use. Spinal Cord Ser Cases. 2023 Jul 29;9(1):37. doi: 10.1038/s41394-023-00597-z.
PubMed 37516745
Emmanuel A, Kumar G, Christensen P, Mealing S, Storling ZM, Andersen F, Kirshblum S. Long-Term Cost-Effectiveness of Transanal Irrigation in Patients with Neurogenic Bowel Dysfunction. PLoS One. 2016 Aug 24;11(8):e0159394. doi: 10.1371/journal.pone.0159394. eCollection 2016.
PubMed 27557052

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised Controlled Trial to Evaluate Effectiveness and Cost-Effectiveness of Intermittent Colonic Exoperistalsis Treatment With MOWOOT Medical Device in Adults With Chronic Constipation Using Trans-Anal Irrigation.
ClinicalTrials.gov ID: NCT04666155
Acronym / sponsor ID: MOTACC / MOW-06-2023
Conditions: Constipation - Functional, Constipation-predominant Irritable Bowel Syndrome, Constipation Chronic Idiopathic, Constipation; Neurogenic, Constipation
Study type: Interventional
Recruitment status: Completed
Enrolment: 86 participants (actual)
Lead sponsor: usMIMA S.L.Industry (pharma, biotech, devices)
Collaborators: County Durham and Darlington NHS Foundation Trust, University of York
Study start: 25 Apr 2024 (actual)
Primary completion: 29 Mar 2026 (actual)
Study completion: 29 Mar 2026 (actual)
First posted: 14 Dec 2020 (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.

Detailed description

The RCT will assess clinical effectiveness by means of quantitative and qualitative variables, and the cost effectiveness by means of economic outcomes.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2
Model description: Randomized controlled trial

Arm	Type	Receives
Intermittent Colon Exoperistalsis (ICE)	Experimental	Device: Intermittent Colonic Exoperistalsis with MOWOOT device, Device: Standard of care with Trans-Anal IrrigationIntermittent Colon Exoperistalsis (ICE) Treatment with Mowoot device. 20min daily for 12 weeks
Standard-of-care with Trans-anal Irrigation (Soc TAI)	Active comparator	Device: Standard of care with Trans-Anal IrrigationStandard-of-care with Trans-anal Irrigation (Soc TAI) for chronic constipation for 12 weeks.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Any gender 18 years or older
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
PAC-QOL ≥1.8
Using TAI for at least 3 months

Key exclusion criteria (20 listed)

Irritable Bowel Syndrome with Diarrhoea (IBS-D) or alternating constipation and diarrhoea (IBSmix): (not due to laxative use)
Inflammatory Bowel Disease (IBD)
Abdominal perimeter ≤65cm or ≥130cm
Unable to independently use the MOWOOT or TAI technology, unless a carer is available daily to assist
Previous large bowel resection

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
Intermittent Colonic Exoperistalsis with MOWOOT devicePatients under the experimental arm of the study should place the belt of the Mowoot device on the abdomen and use it for 20 minutes every day for 12 weeks. They should continue with their individualized standard of care againts constipation for the first 4 weeks. During the following 8 weeks of the interventional period of 12weeks, their use of SocTAI will be considered "rescue intervention". The 8weeks following the 12weeks of intervention, they can keep on using ICE device.or SocTAI or both.	Device	Intermittent Colon Exoperistalsis (ICE)
Standard of care with Trans-Anal IrrigationPatients under the active comparator arm of the study should continue with their individualized standard of care againts constipation for the 12weeks of intervention. The following 8 weeks they can keep on using SocTAI or ICE device or both.	Device	Intermittent Colon Exoperistalsis (ICE), Standard-of-care with Trans-anal Irrigation (Soc TAI)

Primary outcome

Changes in quality of life (PAC-QoL)
Time frame: End of treatment (week 14, last week of treatment) - Baseline (before treatment)
Semi-quantitative assessment of the changes in quality of life respect to chronic constipation, of patients using the ICE treatment with MOWOOT compared with patients under standard of care treatment. The measure is done according to PAC-QoL questionnaire.

21 secondary outcomes

Frequency of use of TAI
Time frame: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Frequency of use of ICE
Time frame: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Changes in Constipation symptoms (PAC-SYM)
Time frame: 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment)
Changes in quality of life according to Euroqol ED5D5L
Time frame: 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment)
Changes in the number of days evacuation felt complete
Time frame: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Changes in the maximum number of consecutive days without complete bowel movements
Time frame: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Changes in the number of days with a normal stool
Time frame: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Changes in the mean time spent in bowel management
Time frame: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Changes in the mean time spent per evacuation
Time frame: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Changes in the number of days with fecal incontinence
Time frame: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Changes in laxative use
Time frame: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Changes in the use of SoC TAI (HE outcome)
Time frame: Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Number of visits to GP and specialists (HE outcome)
Time frame: 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment)
Number of visits to Accident & Emergency room (HE outcome)
Time frame: 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment)
Continence Service consultations (HE outcome)
Time frame: 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment)
Number of hospital admissions (HE outcome)
Time frame: 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment)
Days spent at hospital (HE outcome)
Time frame: 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment)
Use of relevant medications (HE outcome)
Time frame: 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment)
Use of relevant supplies (HE outcome)
Time frame: 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment)
Incremental cost/effectiveness ratio (ICER) and Quality-Adjusted Life years (QALYS) (HE outcome)
Time frame: EQ-5D-5L3 answered 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment)
Adverse events and Serious adverse events
Time frame: Evrey day during all the follow-up, from recruitment (visit 0, day 0) to the end of study (visit 3, day 154)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
Background: PubMed 17117000Ayas S, Leblebici B, Sozay S, Bayramoglu M, Niron EA. The effect of abdominal massage on bowel function in patients with spinal cord injury. Am J Phys Med Rehabil. 2006 Dec;85(12):951-5. doi: 10.1097/01.phm.0000247649.00219.c0.
Background: PubMed 19283590Diego MA, Field T. Moderate pressure massage elicits a parasympathetic nervous system response. Int J Neurosci. 2009;119(5):630-8. doi: 10.1080/00207450802329605.
Background: PubMed 21943617Sinclair M. The use of abdominal massage to treat chronic constipation. J Bodyw Mov Ther. 2011 Oct;15(4):436-45. doi: 10.1016/j.jbmt.2010.07.007. Epub 2010 Aug 25.
Background: PubMed 16036506Marquis P, De La Loge C, Dubois D, McDermott A, Chassany O. Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire. Scand J Gastroenterol. 2005 May;40(5):540-51. doi: 10.1080/00365520510012208.
Background: PubMed 10522604Frank L, Kleinman L, Farup C, Taylor L, Miner P Jr. Psychometric validation of a constipation symptom assessment questionnaire. Scand J Gastroenterol. 1999 Sep;34(9):870-7. doi: 10.1080/003655299750025327.
Background: PubMed 27147121Drossman DA, Hasler WL. Rome IV-Functional GI Disorders: Disorders of Gut-Brain Interaction. Gastroenterology. 2016 May;150(6):1257-61. doi: 10.1053/j.gastro.2016.03.035. No abstract available.
Background: PubMed 28983926Yiannakou Y, Tack J, Piessevaux H, Dubois D, Quigley EMM, Ke MY, Da Silva S, Joseph A, Kerstens R. The PAC-SYM questionnaire for chronic constipation: defining the minimal important difference. Aliment Pharmacol Ther. 2017 Dec;46(11-12):1103-1111. doi: 10.1111/apt.14349. Epub 2017 Oct 6.
Background: PubMed 29768326Forootan M, Bagheri N, Darvishi M. Chronic constipation: A review of literature. Medicine (Baltimore). 2018 May;97(20):e10631. doi: 10.1097/MD.0000000000010631.
Background: PubMed 20557387Lamas K, Lindholm L, Engstrom B, Jacobsson C. Abdominal massage for people with constipation: a cost utility analysis. J Adv Nurs. 2010 Aug;66(8):1719-29. doi: 10.1111/j.1365-2648.2010.05339.x. Epub 2010 Jun 16.
Background: PubMed 33512794McClurg D, Booth L, Herrero-Fresneda I. Safety and Efficacy of Intermittent Colonic Exoperistalsis Device to Treat Chronic Constipation: A Prospective Multicentric Clinical Trial. Clin Transl Gastroenterol. 2020 Dec;11(12):e00267. doi: 10.14309/ctg.0000000000000267.
Background: PubMed 37516745Bremer J, Bremer J, Konig M, Kossmehl P, Kurze I, Obereisenbuchner J, Weinschenk E, Herrero-Fresneda I. Intermittent colonic exoperistalsis for chronic constipation in spinal cord-injured individuals. A long-term structured patient feedback survey to evaluate home care use. Spinal Cord Ser Cases. 2023 Jul 29;9(1):37. doi: 10.1038/s41394-023-00597-z.
Results publication: PubMed 27557052Emmanuel A, Kumar G, Christensen P, Mealing S, Storling ZM, Andersen F, Kirshblum S. Long-Term Cost-Effectiveness of Transanal Irrigation in Patients with Neurogenic Bowel Dysfunction. PLoS One. 2016 Aug 24;11(8):e0159394. doi: 10.1371/journal.pone.0159394. eCollection 2016.
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. This study is not recruiting at the moment.

Immaculada Herrero, PhD study chair

usMIMA S.L.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 20 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: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in quality of life (PAC-QoL) (time frame: End of treatment (week 14, last week of treatment) - Baseline (before treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04666155, which also lists 12 linked publications.

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 3 Jun 2026; AzTrials last refreshed its copy on 4 Nov 2026.