RecruitingNot ApplicableNCT04707976

Comparing Transanal Irrigation With Navina Smart vs. Standard Bowel Care in Patients With Multiple Sclerosis

A Randomized Controlled Trial Comparing the Efficacy of Transanal Irrigation With Navina Smart Versus Standard Bowel Care in Patients With Multiple Sclerosis

Sponsor

Wellspect HealthCare

Enrollment

92 participants

Start Date

Dec 1, 2020

Study Type

INTERVENTIONAL

Conditions

Multiple Sclerosis Fecal Incontinence Neurogenic Bowel (Disorder)Fecal Constipation

Summary

A randomized, superiority, controlled, interventional, prospective, multicentre, post-market study of TAI with Navina™ Smart versus Standard Bowel Care performed in a population of 92 subjects suffering from Multiple Sclerosis and confirmed Neurogenic Bowel Dysfunction. The study is expected to last for a total of 8 weeks per subject with two scheduled site visits.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a smart transanal irrigation system (Navina Smart — a device that flushes water through the bowel via the rectum) against standard bowel care methods in people with multiple sclerosis (MS) who have bowel problems such as constipation or fecal incontinence. **You may be eligible if...** - You are 18 or older - You have confirmed multiple sclerosis (MS) - Your bowel problems are related to your MS diagnosis - You have significant bowel symptoms (constipation and/or incontinence based on standardized scores) - You have never used a transanal irrigation system before **You may NOT be eligible if...** - You have used a transanal irrigation system before - You are not a suitable candidate for this type of bowel treatment - You have conditions that make the procedure unsafe (such as active bowel disease or recent bowel surgery) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENavina Smart

CE-marked NavinaTM Smart including Navina Smart App.

OTHERStandard Bowel Care

Bowel care will be scheduled at least every 2nd day according to a defined study specific standard bowel care protocol. Diet, fluids, abdominal massage, regular physical activity and medications will be used if non-interventional treatment is insufficient.