Cost-effectiveness of ICE With MOWOOT

Study Overview
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Brief Summary
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The objective of the study is to quantitatively assess the cost-effectivenes of the ICE treatment with MOWOOT compared a standard of care.

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

Official Title
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Intermittent Colonic Exoperistalsis (ICE) Treatment With MOWOOT Medical Device to Treat Chronic Constipation in Adults. A Cost-effectiveness Study.

Conditions
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Constipation - Functional, Constipation-predominant Irritable Bowel Syndrome

Intervention / Treatment
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* Device: Intermittent Colonic Exoperistalsis with MOWOOT device
* Combination Product: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects older than 18 years (both male and female). Fulfil Rome IV criteria for Functional Constipation or Irritable Bowel Syndrome Contipation (IBSC) or both Subjects whose constipation aetiology is not only functional defecatory dysfunction (FDD). Subjects bothered by their constipation. Subjects that have had no abdominal massage for at least 2 months. Subjects with ability to understand the study Subjects with ability to use MOWOOT or have someone to apply it. Subjects that consent to participate in an informed way Exclusion Criteria: Pregnancy or attempt to become pregnant in the next 6 months. IBSD or IBSmix: Subjects alternating constipation and diarrhoea (not due to laxative use) Inflammatory Bowel Disease FDD as the only root cause for constipation Neurogenic Bowel Dysfunction as the only root cause for constipation Previous large bowel surgery The presence of a stoma External rectal prolapse Active anorexia or bulimia Mental inability to give informed consent Active abdominal cancer Large inguinal or umbilical hernia Recent abdominal scars, abdominal wounds or skin disorders that may make abdominal massage uncomfortable Intra-abdominal implants (catheters, Sacral Anterior Root Stimulator (SARS), medication pumps…) Subjects already undertaking or have undertaken abdominal massage unless they underwent a previous washout period of at least 2 months. Inability to undertake the massage with the device themselves or the lack of a carer willing to do it. Participation in another parallel clinical trial or less than 2 months from participation in a previous clinical trial Subjects who do not consent to participate.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intermittent Colon Exoperistalsis<br>ICE Treatment with Mowoot device. 20min dayly for 12 weeks | Device: Intermittent Colonic Exoperistalsis with MOWOOT device<br>* 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.<br>Combination Product: Standard of care<br>* Patients under the active comparator arm of the study should continue with their individualized standard of care againts constipation, for 12 weeks. The standard of care uses to be different in each patient: both in drugs and doses taken (laxatives) as well as in formulation/presentation (pills, laxative syrup, suppos, etc...) and even in other help to evacuation (micro or macro enemas, digitation, etc...).<br>|
| Active Comparator: Standard-of-Care<br>Standard-of-care for chronic constipation for 12 weeks. | Combination Product: Standard of care<br>* Patients under the active comparator arm of the study should continue with their individualized standard of care againts constipation, for 12 weeks. The standard of care uses to be different in each patient: both in drugs and doses taken (laxatives) as well as in formulation/presentation (pills, laxative syrup, suppos, etc...) and even in other help to evacuation (micro or macro enemas, digitation, etc...).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in quality of life | 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. | Questionnaire filled at 3 time points along the study: Baseline (before treatment), Treatment (at week 12, the last week of intervention), and post-Treatment (6 months after starting the intervention, week 24) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Constipation symptoms | 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. | Questionnaire filled at 3 time points along the study: Baseline (before treatment), Treatment (at week 12, the last week of intervention), and post-Treatment (at the end of follow-up, week 24) | 
| Economic outcome | A Budget Impact Model (BIM) will be described by analysing the impact of adopting the ICE MOWOOT device instead of the Standard-of-care in England. The direct costs associated with chronic constipation to be considered within the BIM are largely expected to be the intervention costs and the cost of hospitalisation, but we will also consider any other costs across the care pathway | At the end of intervention (week 12) and at the end of follow-up (week 24). |