NCT04262752

MOWOOT Device to Treat Constipation in Adults

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: usMIMA S.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Constipation
• Constipation; Neurogenic
• Constipation Chronic Idiopathic

Interventions

Type	Name	Description
DEVICE	intermittent colonic exo-peristaltic massage treatment with the MOWOOT medical 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.

Timeline

• Start date: 2018-01-11
• Primary completion: 2019-05-13
• Completion: 2019-06-07
• First posted: 2020-02-10
• Last updated: 2021-04-23

Locations

3 sites across 2 countries: Spain, United Kingdom