MOWOOT Device Treatment for Adults with Chronic Constipation

Not Applicable

Recruiting

• Conditions: Constipation Chronic Idiopathic; Constipation-predominant Irritable Bowel Syndrome; Constipation - Functional; Constipation; Neurogenic; Constipation
• Interventions: Device: Intermittent Colonic Exoperistalsis with MOWOOT device; Device: Standard of care with Trans-Anal Irrigation

• Registration Number: NCT04666155
• Lead Sponsor: usMIMA S.L.

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.

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 Timeline

• Study First Submitted: 2020-12-07
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-14
• Study Start: 2024-04-25
• Status Verified: 2024-11
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-05-25
• Study Completion: 2025-05-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 86

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 (this excludes laxatives which may be used as required up to three days before the 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent Colon Exoperistalsis (ICE)	Intermittent Colonic Exoperistalsis with MOWOOT device	Intermittent Colon Exoperistalsis (ICE) Treatment with Mowoot device. 20min daily for 12 weeks
Standard-of-care with Trans-anal Irrigation (Soc TAI)	Standard of care with Trans-Anal Irrigation	Standard-of-care with Trans-anal Irrigation (Soc TAI) for chronic constipation for 12 weeks.
Intermittent Colon Exoperistalsis (ICE)	Standard of care with Trans-Anal Irrigation	Intermittent Colon Exoperistalsis (ICE) Treatment with Mowoot device. 20min daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Changes in quality of life (PAC-QoL)	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 Outcome Measures

Name	Time	Method
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.	Quantitative assessment of the change in the number of days per week evacuation felt complete at the end of the day
Changes in laxative use	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
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.	How many days per week the patient has used ICE
Changes in the maximum number of consecutive days without complete bowel movements	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
Changes in the number of days with a normal stool	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
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.	How many days per week the patient has used TAI
Changes in the use of SoC TAI (HE outcome)	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
Number of visits to GP and specialists (HE outcome)	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
Number of hospital admissions (HE outcome)	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
Days spent at hospital (HE outcome)	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
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)	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.
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)	Semi-quantitative assessment of the changes in self-perceived quality of life according to the EQ-5D-5L instrument
Changes in the mean time spent in bowel management	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
Changes in the mean time spent per evacuation	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
Changes in the number of days with fecal incontinence	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
Use of relevant supplies (HE outcome)	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
Continence Service consultations (HE outcome)	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
Number of visits to Accident & Emergency room (HE outcome)	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
Use of relevant medications (HE outcome)	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
Incremental cost/effectiveness ratio (ICER) and Quality-Adjusted Life years (QALYS) (HE outcome)	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
Adverse events and Serious adverse events	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)

Trial Locations

Locations (1)

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