MOWOOT Device to Treat Constipation in Adults

NCT04262752 | Completed DMC

• 1 other identifier: MOW-01-2017
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 3

Brief Summary

The aim was to assess the safety and effectiveness of the automatic colon-specific massage with the MOWOOT device for patients suffering from chronic constipation due to Multiple Sclerosis, Parkinson Disease (NBD) or other unknown causes (Idiopathic).The hypothesis is that this treatment administered daily in home-use settings could ameliorate constipation in chronically affected people.

Conditions

Constipation; Constipation; Neurogenic; Constipation Chronic Idiopathic

Outcome Measures

Primary Outcomes (1)

• Number of complete bowel movements per week

  Complete bowel movements mean that the subjects feel they have emptied their bowels completely.

  Daily for 9 weeks

Secondary Outcomes (8)

• Changes in Constipation symptoms according to the KESS score

  Once a week at weeks 2, 6 and 9

• Changes in fecal consistency according to Bristol scale

  Once a week at weeks 2, 6 and 9

• Changes in Colonic transit time (CTT)

  Once a week at weeks 2 and 6

• Changes in laxative consumption per week

  Daily for 9 weeks

• Changes in other manoeuvres needed to assist defecation per week

  Daily for 9 weeks

Study Arms (1)

chronically constipated people

EXPERIMENTAL

Adults with chronic constipation due to either neurogenic bowel dysfunction (NBD) as consequence of a neurogenic condition such as Multiple sclerosis or Parkinson Disease, or to unkwon origin (Idiopathic No-NBD)

Device: intermittent colonic exo-peristaltic massage treatment with the MOWOOT medical device

Interventions

intermittent colonic exo-peristaltic massage treatment with the MOWOOT medical device DEVICE

The MOWOOT massager belt is connected to the desktop device and is the component which is in contact with the subject giving the abdominal massage action. The massager belt, which is placed on the user's abdominal area, administers a specific abdominal massage on the ascendant and descendent segments of the colon. This massage emulates the techniques used by professional therapists through a series of pneumatic actuators operating like the movement of a wave transmitting movement through the colon. The type and speed of the massage can usually be regulated by an algorithm that controls the operation from the desktop device. For the present clinical trial, time and force will stay fixed on 20 minutes and force 3 (0'6-0'7 bar). Subjects will not be able to choose other massage options. Subjects should use the MOWOOT device once a day for 20 min (1 complete treatment) ideally at the same hour every day for the 4 weeks of the interventional treatment period.

chronically constipated people

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fulfil Rome III criteria for functional constipation: include any two of the six symptoms of straining, lumpy or hard stools, sensation of incomplete evacuation, sensation of anorectal obstruction or blockage, digital manoeuvres and less than 3 defecations per week. These should be present during at least 25% of defecations for the last 3 months with symptom onset at least 6 months before the diagnosis;
• Failed routine management of constipation (lack of response to non-stimulant laxatives), or subjects responding to laxative treatment but with secondary diarrhoea and faecal incontinence.
• Duration of constipation more than 6 months.
• If subjects have a diagnosis of multiple sclerosis (MS) or Parkinson disease (PD), it is in a stable phase (no major change in medication for 1 month).
• Subject that have had no abdominal massage for at least 2 months.
• Subjects bothered by their constipation.
• Ability to understand the study
• Ability to come to the outpatient clinic during the study
• Subjects whose constipation aetiology is not only pelvic floor dyssynergia.
• Ability to use MOWOOT or have someone to apply it.
• Subjects that consent to participate in an informed way

You may not qualify if:

• Pregnancy or attempt to become pregnant in the next 6 months.
• Subjects alternating constipation and diarrhoea (not due to laxative use)
• 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
• Inflammatory Bowel Disease (IBD)
• Recent abdominal scars, abdominal wounds or skin disorders that may make abdominal massage uncomfortable
• Intra-abdominal implants (catheters, SARS, medication pumps…)
• Subjects already undertaking or have undertaken abdominal massage unless they underwent a previous washout period of at least 2 month.
• 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 month from participation in a previous clinical trial

Sponsors & Collaborators

• usMIMA S.L.: lead

Study Sites (3)

Hospital de Terrassa

Terrassa, Barcelona, Spain

Location

Hospital Universitari MútuaTerrassa

Terrassa, Barcelona, Spain

Location

Glasgow Caledonian University

Glasgow, Scotland, United Kingdom

Location

Related Publications (28)

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  PMID: 33512794 DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Immaculada Herrero-Fresneda, PhD

  usMIMA S.L.

  STUDY CHAIR

• Doreen McClurg, PhD

  Glasgow Caledonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each subject in the study will be his/her own control in a BEFORE-AFTER Study, with one group assessed before intervention, during intervention and after intervention. Additionally, in order to discuss and analyse the results, further subgroups could be made on the basis of aetiology of the chronic constipation to compare results, i.e.: subjects with constipation derived from Neurogenic Bowel Disease (NBD) vs Idiopathic (No NBD) subjects whose constipation is from unknown origin

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 10, 2020
• Study Start: January 11, 2018
• Primary Completion: May 13, 2019
• Study Completion: June 7, 2019
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); ES (2)