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Cost-effectiveness of ICE With MOWOOT

Primary Purpose

Constipation - Functional, Constipation-predominant Irritable Bowel Syndrome

Status

Not yet recruiting

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Intermittent Colonic Exoperistalsis with MOWOOT device

Standard of care

About this trial

This is an interventional other trial for Constipation - Functional

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intermittent Colon Exoperistalsis

Standard-of-Care

Arm Description

ICE Treatment with Mowoot device. 20min dayly for 12 weeks

Standard-of-care for chronic constipation for 12 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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

Full Information

NCT ID

NCT04666155

First Posted

December 7, 2020

Last Updated

May 19, 2022

Sponsor

usMIMA S.L.

Collaborators

County Durham and Darlington NHS Foundation Trust, University of York, EIT Health

1. Study Identification

Unique Protocol Identification Number

NCT04666155

Brief Title

Cost-effectiveness of ICE With MOWOOT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 15, 2023 (Anticipated)

Primary Completion Date

August 1, 2023 (Anticipated)

Study Completion Date

October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

usMIMA S.L.

Collaborators

County Durham and Darlington NHS Foundation Trust, University of York, EIT Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation - Functional, Constipation-predominant Irritable Bowel Syndrome

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Randomized controlled trial

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intermittent Colon Exoperistalsis

Arm Type

Experimental

Arm Description

ICE Treatment with Mowoot device. 20min dayly for 12 weeks

Arm Title

Standard-of-Care

Arm Type

Active Comparator

Arm Description

Standard-of-care for chronic constipation for 12 weeks.

Intervention Type

Device

Intervention Name(s)

Intermittent Colonic Exoperistalsis with MOWOOT device

Intervention Description

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.

Intervention Type

Combination Product

Intervention Name(s)

Standard of care

Intervention Description

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...).

Primary Outcome Measure Information:

Title

Changes in quality of life

Description

Time Frame

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 Measure Information:

Title

Changes in Constipation symptoms

Description

Time Frame

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)

Title

Economic outcome

Description

Time Frame

At the end of intervention (week 12) and at the end of follow-up (week 24).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Immaculada Herrero, PhD

Phone

+34935106653

ihf@mowoot.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Immaculada Herrero, PhD

Organizational Affiliation

usMIMA S.L.

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

17117000

Citation

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Results Reference

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Citation

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

10522604

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.

Results Reference

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PubMed Identifier

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Citation

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PubMed Identifier

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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.

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Citation

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Cost-effectiveness of ICE With MOWOOT

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