RecruitingNAINTERVENTIONAL

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

This study is looking at adults in the UK who have multiple sclerosis (MS) and also experience bowel issues like constipation or accidental bowel leakage. Researchers want to compare a new type of bowel care called Transanal Irrigation (TAI) using a device called Navina Smart with the standard bowel care that patients usually receive. TAI involves gently flushing the bowel with water to help manage symptoms. The main goal is to find out if the Navina Smart device is more effective than current approaches in helping people manage their bowel problems. It's a randomised study, meaning participants will be assigned to one of the two groups by chance. Each person in the study will take part for about 8 weeks and will have two appointments at a clinic.

At a glance

Status

Recruiting

Phase

Sponsor

Wellspect HealthCare

Enrolment target

Start

01 Dec 2020

Estimated completion

01 Feb 2025

Neurogenic Bowel (Disorder)Fecal Constipation Fecal Incontinence Multiple Sclerosis

What is this study about?

If you have multiple sclerosis (MS), you might also experience problems with your bowels, such as constipation or accidental bowel leakage. This can be very disruptive and impact your daily life. This study is designed to explore ways to help people living with MS better manage these symptoms.

The study focuses on a treatment called Transanal Irrigation (TAI), which is a way to help clear the bowel using water. They are looking specifically at a newer device called Navina Smart. The researchers want to compare how well this device works against the usual care that people with MS receive for their bowel issues. By doing this, they hope to find out if Navina Smart offers an improved way to manage these challenging symptoms.

This kind of study helps doctors and patients understand which treatments are most effective. If Navina Smart proves to be more helpful, it could become a common treatment option, potentially improving the quality of life for many people with MS who struggle with bowel problems.

Key takeaways

This study compares two ways to manage bowel issues in adults with MS.
It investigates a new device called Navina Smart versus standard bowel care.
Participants will be randomly assigned to one of the two groups.
The study lasts 8 weeks for each person, including two clinic visits.
It aims to find better ways to help people with MS manage bowel problems.

Who may be eligible?

To join this study, you need to be an adult (aged 18 or over) diagnosed with MS by your doctor. You should also be experiencing bowel problems, such as accidental bowel leakage or severe constipation, that are linked to your MS. It's important that you haven't used any similar TAI device before, and your doctor thinks this type of treatment is suitable for you. You also need to be able to read and understand information about the study.

There are certain reasons why you might not be able to join. For example, if you have certain other serious bowel or anal conditions like current severe inflammation, a history of bowel surgery (like haemorrhoid removal), severe narrowing of the bowel, or untreated blockages. Also, if you have a serious bladder infection, are pregnant or breastfeeding, have recently had certain other medical procedures, or are taking certain medications like strong blood thinners, you likely wouldn't be able to take part.

Quick self-check

Are you 18 years old or older?
Do you have a confirmed diagnosis of Multiple Sclerosis?
Do you experience bowel problems (like constipation or accidental leakage) linked to your MS?
Have you never used a Transanal Irrigation (TAI) system before?
Can you read and understand information about medical studies?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you will be randomly assigned to one of two groups: either using the Navina Smart device for bowel care or continuing with your standard bowel care. You won't get to choose which group you're in.

The study will last for a total of 8 weeks for each person. During this time, you will have two scheduled visits to a clinic. These visits will likely involve checks on your symptoms and how you're feeling, to help the researchers understand how well each treatment is working. You will be asked about your bowel habits and overall wellbeing.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might find that the specific treatment you receive helps improve your bowel symptoms, which could lead to a better quality of life. Even if it doesn't directly benefit you, the information gathered from your participation will help other people with MS in the future. As with any medical procedure, there's a small chance of side effects or discomfort, which the study team will discuss with you. You have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

Aarhus University Hospital
Aarhus, Denmark· Recruiting
Hospital Tenon Service de Neuro-urologie et d'Explorations Périnéales
Paris, France· Recruiting
Azienda Ospedaliero-Universitaria of Ferrara
Ferrara, Italy· Recruiting
AISM Liguria Rehabilitation Centre
Genoa, Italy· Recruiting
AOU Careggi
Florence, Italy· Recruiting
Azienda Ospedaliero Universitaria Consorziale Policlinico con sede in Bari
Bari, Italy· Recruiting
La Fé University Hospital
Valencia, Spain· Recruiting
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland· Withdrawn
University College London Hospital
London, United Kingdom· Recruiting

Common questions

What is Transanal Irrigation (TAI)?

TAI is a method used to help clear the bowels, often involving gently flushing the lower part of the bowel with water to manage constipation or accidental bowel leakage.

What is Neurogenic Bowel Dysfunction?

This term describes bowel problems like constipation or accidental leakage that happen because of damage to the nerves, often due to conditions like Multiple Sclerosis.

What does 'randomised' mean in a study?

It means you will be put into one of the treatment groups by chance, like flipping a coin. This helps make the study fair and scientific.

Will I still receive my usual MS care?

Yes, you will continue to receive all your standard care and treatments for Multiple Sclerosis during the study, unless the study intervention directly affects it.

How long will I be involved in the study?

Each person takes part for approximately 8 weeks, with two visits needed at the clinic during that time.

How to find out more

Wellspect HealthCare

mace@wellspect.com +46 31 376 40 00 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.