MOWOOT Device to Treat Constipation in Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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Automatic Colon-specific Massage With MOWOOT Medical Device to Treat Chronic Constipation in Adults

Conditions
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Constipation, Constipation; Neurogenic, Constipation Chronic Idiopathic

Intervention / Treatment
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* Device: intermittent colonic exo-peristaltic massage treatment with the MOWOOT medical device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Intervention Model: Single Group Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chronically constipated people<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Constipation symptoms according to the KESS score | Knowles Eccersley Scott Symptom Score (KESS) is an 11-item questionnaire to diagnose constipation. The assessed items are duration of constipation, laxative use, frequency of bowel movements, unsuccessful evacuatory attempts, feeling incomplete evacuation, abdominal pain, bloating, enemas/digitation, time taken, difficulty evacuation, and stool consistency. Total score ranges from 0 (no symptoms) to 39 (high symptom severity). A cut-off score of ≥ 11 indicates constipation. | Once a week at weeks 2, 6 and 9 | 
| Changes in fecal consistency according to Bristol scale | Bristol stool scale is a worldwide used visual analogue scale that semi-quantitatively assesses faecal consistency from 1 (hard, pellet feces) to 7 (liquid diarrhea). Categories 1 and 2 indicate constipation, 3 and 4 are considered normal, and 5 to 7 indicate soft to liquid feces. | Once a week at weeks 2, 6 and 9 | 
| Changes in Colonic transit time (CTT) | Colonic transit time (CTT) involved the ingestion of 20 radio-opaque markers followed by a single plain abdominal x-ray 5 days later. | Once a week at weeks 2 and 6 | 
| Changes in laxative consumption per week | Patients should record on the Bowel diary the names and dose of laxatives, as well as the number of days taking laxatives, among other variables (desire to defecate, number of complete defecations, number of unsuccessful evacuation attempts, painful evacuation, abdominal pain, time taken to evacuate, straining effort, feeling of incomplete evacuation, other symptoms as bloating, influence of constipation on daily activities, need of digital assistance, and concomitant medication) | Daily for 9 weeks | 
| Changes in other manoeuvres needed to assist defecation per week | Patients should record on the Bowel diary any other manoeuvres needed to assist defecation (such as enemas, digitation, etc.; names and dose) among other variables (desire to defecate, number of complete defecations, number of unsuccessful evacuation attempts, painful evacuation, abdominal pain, time taken to evacuate, straining effort, feeling of incomplete evacuation, other symptoms as bloating, influence of constipation on daily activities, laxatives, and concomitant medication) | Daily for 9 weeks | 
| Changes in quality of life according to PAC-QoL | The PAC-QoL is a validated self-reported questionnaire that measures quality of life of subjects with constipation. It is composed of 28 items grouped into four subscales: physical discomfort, psychosocial discomfort, worried and concerns, and satisfaction. Each item is scored from 0 to 4. The lower the score the better quality of life | Once a week at weeks 2, 6 and 9 | 
| Changes in subject satisfaction according to a visual analogue scale | Patients were asked to rate their individual satisfaction with bowel function by answering the question How do you feel about your defecatory function? on a visual analogue scale (VAS) from 0 (No problems to defecate) to 10 (A lot of problems to defecate). | Once a week at weeks 2, 6 and 9 | 
| Adherence to treatment | The number of completed treatments and the total minutes of each treatment received (completed or not) are automatically registered by the software of the MOWOOT device. | Once a week during the 4 weeks of the interventional treatment |