Clinical trial NCT04262752: MOWOOT Device to Treat Constipation in Adults
Official title: Automatic Colon-specific Massage With MOWOOT Medical Device to Treat Chronic Constipation in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Constipation; Neurogenic
Constipation Chronic Idiopathic
Lead sponsor: usMIMA S.L.
Sponsor class: INDUSTRY
First posted: 2020-02-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: TREATMENT

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.

Detailed description: The study is an international multi-centre trial using an experimental strategy of once daily abdominal massage using MOWOOT for 4 weeks.

The trial includes a 2-week pre-intervention period with the usual constipation treatment without MOWOOT, followed by a 4-week intervention period consisting of 20 minutes' daily massage with MOWOOT (with or without the usual constipation treatment, as required by subject), followed by 1week wash-out period and finished by 2 weeks' post-intervention follow-up period. The same outcome measures will be assessed before and immediately after the treatment, and again after a washout period.

The principal endpoint of the procedure will be based on constipation improvement (complete bowel movements per week). The secondary endpoints will be based on chronic constipation defined as Rome III criteria assessed by the KESS score, Bristol scale, colonic transit time, dose of laxatives and/or other measures to assist defecation and quality of life. These secondary endpoints regarding defecatory function will be evaluated during intervention and compared with 2 weeks before intervention and 2 weeks after intervention following one week of wash out.

The null hypothesis (H0) is that there is no difference between before and after treatment, against an alternative hypothesis (H1) assuming a difference between the treatments.

Two tailed tests with 95% confidence intervals will be produced for the comparisons of interest in order to investigate the magnitude of treatment effects.

MOWOOT is a "wearable" medical device which emulates the massage techniques used by the professional therapists in order to provide a colon-specific abdominal massage. The product is focused on people who suffer from chronic constipation due to neurogenic bowel disease and prolonged intestinal transit time.

MOWOOT is composed by two main pieces: the desktop device and the massager belt. The desktop device provides the source of energy as well as it contains the panel control which allows the management of the device function and allows to select the treatment time and pressure. The massager belt is connected to the desktop device and is the component which is in contact with the subject giving the abdominal massage action.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Subjects who do not consent to participate.

Primary outcomes:
measure: Number of complete bowel movements per week
timeFrame: Daily for 9 weeks
Secondary outcomes:
measure: Changes in Constipation symptoms according to the KESS score
timeFrame: Once a week at weeks 2, 6 and 9
measure: Changes in fecal consistency according to Bristol scale
timeFrame: Once a week at weeks 2, 6 and 9
measure: Changes in Colonic transit time (CTT)
timeFrame: Once a week at weeks 2 and 6
measure: Changes in laxative consumption per week
timeFrame: Daily for 9 weeks
measure: Changes in other manoeuvres needed to assist defecation per week
timeFrame: Daily for 9 weeks
measure: Changes in quality of life according to PAC-QoL
timeFrame: Once a week at weeks 2, 6 and 9
measure: Changes in subject satisfaction according to a visual analogue scale
timeFrame: Once a week at weeks 2, 6 and 9
measure: Adherence to treatment
timeFrame: Once a week during the 4 weeks of the interventional treatment
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Hospital de Terrassa
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Universitari MútuaTerrassa
state: Barcelona
city: Glasgow
country: United Kingdom
facility: Glasgow Caledonian University
state: Scotland
Study officials:
affiliation: usMIMA S.L.
name: Immaculada Herrero-Fresneda, PhD
role: STUDY_CHAIR
affiliation: Glasgow Caledonian University
name: Doreen McClurg, PhD
role: PRINCIPAL_INVESTIGATOR
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