MOWOOT Device Treatment for Adults With Chronic Constipation

N/AActive Not RecruitingNCT04666155

usMIMA S.L.86 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

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

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (3)

University Hospital of North Durham, NHS Foundation Trust

Durham, County Durham and Darlington, United Kingdom

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

Hardwick, United Kingdom

The Newcastle Upon Tune Hospitals NHS Foundation Trust.

Newcastle upon Tyne, United Kingdom

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Frequency of use of TAI

How many days per week the patient has used 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

How many days per week the patient has used 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)

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.

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

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

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

Data from ClinicalTrials.gov

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

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

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

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

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

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

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

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

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

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

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

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

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

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)

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

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)

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

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)

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

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)

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

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)

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

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)

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

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)

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

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)

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

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)

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

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

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

Time frame: Evrey day during all the follow-up, from recruitment (visit 0, day 0) to the end of study (visit 3, day 154)