MOWOOT Device Treatment for Adults With Chronic Constipation

Constipation Clinical Trial

— MOTACC  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04666155
• Other study ID #: MOW-06-2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 29, 2024
• Est. completion date: May 2025

Study information

• Verified date: February 2024
• Source: usMIMA S.L.
• Contact: Immaculada Herrero, PhD
• Phone: +34935106653
• Email: ihf[@]mowoot.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 86
• Est. completion date: May 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Any gender 18 years or older

2. 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

3. Bothered by their constipation

4. PAC-QOL =1.8

5. Using TAI for at least 3 months

6. Able to undertake the treatment with TAI or with the device themselves or with a carer willing to do it

7. Able to understand the study requirements

8. Able to understand written and spoken English (due to questionnaire validity)

9. Able and willing to provide written informed consent to participate Exclusion Criteria:

Disease phenotype exclusion criteria:

1. Irritable Bowel Syndrome with Diarrhoea (IBS-D) or alternating constipation and diarrhoea (IBSmix): (not due to laxative use)

2. Inflammatory Bowel Disease (IBD)

Device-related exclusion criteria:

3. Abdominal perimeter =65cm or =130cm

4. Unable to independently use the MOWOOT or TAI technology, unless a carer is available daily to assist

Other medical conditions, medications and contraindications:

5. Previous large bowel resection

6. The presence of a stoma

7. External rectal prolapse

8. Active anorexia or bulimia

9. Active abdominal cancer

10. Large inguinal or umbilical hernia

11. Recent abdominal scars, abdominal wounds or skin disorders that may make abdominal massage uncomfortable

12. Pregnancy or attempt to become pregnant in the next 6 months

13. Use of strong opioids*

14. 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

15. Subjects already undertaking or have undertaken abdominal massage unless they underwent a previous washout period of at least 2 months

16. Participation in another parallel interventional clinical trial or less than 2 months from participation in a previous interventional clinical trial

17. Planned surgery for constipation if it might be within trial dates

Related Conditions & MeSH terms

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

Intervention

Device:
• Intermittent Colonic Exoperistalsis with MOWOOT 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
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
usMIMA S.L.	County Durham and Darlington NHS Foundation Trust, University of York

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.015939 — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency of use of TAI	How many days per week the patient has used TAI	Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Secondary	Frequency of use of ICE	How many days per week the patient has used ICE	Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Secondary	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.	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)
Secondary	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	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)
Secondary	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	Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Secondary	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	Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Secondary	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	Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Secondary	Changes in the mean time spent in bowel management	Quantitative assessment of the change in the mean time spent in bowel management per week	Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Secondary	Changes in the mean time spent per evacuation	Quantitative assessment of the change in the mean time spent per evaquation	Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Secondary	Changes in the number of days with fecal incontinence	Quantitative assessment of the change in the number of days with fecal incontinence per week	Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Secondary	Changes in laxative use	Quantitative assessment of the change in the number of days per week taking laxatives	Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Secondary	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	Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period.
Secondary	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	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)
Secondary	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	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)
Secondary	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	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)
Secondary	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	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)
Secondary	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	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)
Secondary	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	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)
Secondary	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	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)
Secondary	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	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)
Secondary	Adverse events and Serious adverse events	Quantitative and qualitative assessment of adverse events (AEs) and serious adverse events (SAEs)	Evrey day during all the follow-up, from recruitment (visit 0, day 0) to the end of study (visit 3, day 154)