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Completed

NCT Number: NCT04666155

MOWOOT Device Treatment for Adults With Chronic Constipation

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.

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Key information

Conditions

Constipation - Functional Constipation Constipation Chronic Idiopathic Constipation-predominant Irritable Bowel Syndrome Constipation; Neurogenic Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of North Durham, NHS Foundation Trust, Durham, County Durham and Darlington, United Kingdom

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

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

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

Treatment and study plan

Intermittent Colonic Exoperistalsis with MOWOOT device

Device

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 Irrigation

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    How many days per week the patient has used TAI

  2. 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.

    How many days per week the patient has used ICE

  3. 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)

    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.

  4. 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)

    Semi-quantitative assessment of the changes in self-perceived quality of life according to the EQ-5D-5L instrument

  5. 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.

    Quantitative assessment of the change in the number of days per week evacuation felt complete at the end of the day

  6. 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.

    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

  7. 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.

    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

  8. 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.

    Quantitative assessment of the change in the mean time spent in bowel management per week

  9. 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.

    Quantitative assessment of the change in the mean time spent per evaquation

  10. 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.

    Quantitative assessment of the change in the number of days with fecal incontinence per week

  11. 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.

    Quantitative assessment of the change in the number of days per week taking laxatives

  12. 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.

    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

  13. 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)

    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

  14. 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)

    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

  15. 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)

    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

  16. 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)

    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

  17. 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)

    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

  18. 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)

    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

  19. 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)

    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

  20. 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)

    Quantitative assessment of the of ICER and QALYS based on the health-related quality of life questionnaire EQ-5D-5L

  21. 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)

    Quantitative and qualitative assessment of adverse events (AEs) and serious adverse events (SAEs)

Sponsors and collaborators

Lead sponsor

usMIMA S.L.

Industry

Collaborators

  • County Durham and Darlington NHS Foundation Trust
  • University of York

Registry information

Official study 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.

Acronym: MOTACC

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 14, 2020
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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