MOWOOT Device Treatment for Adults With Chronic Constipation

NCT04666155 | Completed

• 1 other identifier: MOW-06-2023
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Constipation Chronic Idiopathic; Constipation; Neurogenic; Constipation - Functional; Constipation; Constipation-predominant Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  End of treatment (week 14, last week of treatment) - Baseline (before treatment)

Secondary Outcomes (21)

• Frequency of use of TAI

  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

  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)

  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

  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

  Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.

Study Arms (2)

Intermittent Colon Exoperistalsis (ICE)

EXPERIMENTAL

Intermittent Colon Exoperistalsis (ICE) Treatment with Mowoot device. 20min daily for 12 weeks

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.

Device: Standard of care with Trans-Anal Irrigation

Interventions

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.

Intermittent Colon Exoperistalsis (ICE)

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.

Intermittent Colon Exoperistalsis (ICE); Standard-of-care with Trans-anal Irrigation (Soc TAI)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• usMIMA S.L.: lead
• University of York: collaborator
• County Durham and Darlington NHS Foundation Trust: collaborator

Study Sites (3)

University Hospital of North Durham, NHS Foundation Trust

Durham, County Durham and Darlington, DH5TW, United Kingdom

Location

University Hospital of North Tees, North Tees & Hartlepool NHS Foundation Trust

Hardwick, United Kingdom

Location

The Newcastle Upon Tune Hospitals NHS Foundation Trust.

Newcastle upon Tyne, United Kingdom

Location

Related Publications (12)

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  PMID: 17117000 BACKGROUND

• 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.

  PMID: 19283590 BACKGROUND

• 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.

  PMID: 21943617 BACKGROUND

• 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.

  PMID: 16036506 BACKGROUND

• 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.

  PMID: 10522604 BACKGROUND

• 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.

  PMID: 27147121 BACKGROUND

• 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.

  PMID: 28983926 BACKGROUND

• Forootan M, Bagheri N, Darvishi M. Chronic constipation: A review of literature. Medicine (Baltimore). 2018 May;97(20):e10631. doi: 10.1097/MD.0000000000010631.

  PMID: 29768326 BACKGROUND

• 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.

  PMID: 20557387 BACKGROUND

• 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.

  PMID: 33512794 BACKGROUND

• 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.

  PMID: 37516745 BACKGROUND

• 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.

  PMID: 27557052 RESULT

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Immaculada Herrero, PhD

  usMIMA S.L.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 14, 2020
• Study Start: April 25, 2024
• Primary Completion: April 2, 2026
• Study Completion: April 2, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)