RecruitingNAINTERVENTIONAL

Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis.

This study is investigating a treatment called transcutaneous tibial neuro-stimulation (TTNS) for bladder problems in people with Multiple Sclerosis (MS). Many people with MS find it hard to empty their bladder properly, and some use a method called clean intermittent self-catheterisation (CISC) to help. This research aims to see if TTNS, which involves gentle electrical impulses near the ankle, can improve how well the bladder empties. Participants will either receive the active TTNS treatment or a dummy treatment (placebo) for 12 weeks. Researchers will then compare the results to understand if TTNS is an effective and safe way to help with these bladder issues.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Lille

Enrolment target

Start

01 Dec 2021

Estimated completion

01 Jun 2026

Multiple Sclerosis Lower Urinary Tract Symptoms

What is this study about?

For people living with Multiple Sclerosis (MS), bladder problems are quite common. One specific issue is called 'voiding dysfunction' or difficulty emptying the bladder completely. This can be frustrating and impact daily life. Some individuals manage by using a technique called clean intermittent self-catheterisation (CISC), which involves temporarily inserting a small, soft tube into the bladder to help drain the urine.

This study is looking into a treatment called transcutaneous tibial neuro-stimulation (TTNS) as a potential way to help with these bladder emptying problems. TTNS involves placing small sticky pads on the skin near your ankle, which then deliver gentle electrical impulses. The idea is that these impulses can help to retrain the nerves that control your bladder activity.

The main goal of this research is to see if TTNS is truly effective and safe in helping people with MS empty their bladders more completely. By comparing the results of those who receive the active treatment with those who get a dummy treatment, the researchers hope to understand if TTNS could become a helpful option for managing this aspect of MS.

Key takeaways

This study investigates a gentle electrical treatment (TTNS) for bladder problems in MS.
It focuses on improving bladder emptying for those who use self-catheterisation.
Participants will get either the active treatment or a dummy version for 12 weeks.
The goal is to see if TTNS is both safe and effective for this condition.
Participation involves daily 30-minute sessions over 12 weeks.

Who may be eligible?

To join this study, you must have a diagnosis of Multiple Sclerosis (MS) and be between 18 and 65 years old. A key requirement is that you are currently managing your bladder by performing clean intermittent self-catheterisation (CISC) because you have difficulty emptying your bladder properly. You also need to be willing to follow all the study instructions and attend all appointments.

There are some reasons why you might not be able to take part. For example, if you have other neurological conditions besides MS, or if your MS is severely impacting your mobility, you wouldn't be eligible. Also, if you have frequent urinary tract infections, certain bladder problems, or if you've recently had similar nerve stimulation treatments, you won't be able to join. Individuals with pacemakers, metal implants in their lower legs, or those who are pregnant are also excluded.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have a confirmed diagnosis of Multiple Sclerosis?
Are you between 18 and 65 years old?
Are you currently using clean intermittent self-catheterisation (CISC) to empty your bladder?
Do you not have a pacemaker or metal implant in your lower leg?
Are you willing and able to attend daily 30-minute treatment sessions for 12 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of two groups: either you'll receive the real TTNS treatment, or a 'dummy' (placebo) TTNS treatment. This means you have an equal chance of being in either group. Both groups will have daily 30-minute sessions of transcutaneous tibial neuro-stimulation for 12 weeks. During these sessions, small pads will be placed on your skin near your ankle. If you're in the active group, you'll feel a gentle electrical sensation; if you're in the placebo group, you won't feel anything, but the process will look the same.

Over the 12 weeks, and at the end of the study, the research team will check how well your bladder is emptying. This will likely involve measuring how much urine you pass and how much remains in your bladder. The total duration of your active involvement in the study, including daily sessions and assessments, will be 12 weeks.

Potential risks and benefits

Taking part in this study may or may not directly benefit you. The potential benefit is that the TTNS treatment could improve your ability to empty your bladder, which might make daily life easier. However, there's also a chance you could be in the placebo group and not receive the active treatment. Risks associated with TTNS are generally low, but may include some skin irritation where the pads are placed. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Hop Claude Huriez Chu Lille
Verified postcode
Lille, France· Recruiting

Common questions

What is 'voiding dysfunction'?

It means having trouble emptying your bladder properly, which can lead to urine being left behind. This is a common issue for some people with MS.

What is clean intermittent self-catheterisation (CISC)?

It's a way some people manage their bladder by temporarily inserting a small, soft tube themselves to help drain urine completely.

What is transcutaneous tibial neuro-stimulation (TTNS)?

It's a treatment where gentle electrical impulses are delivered through the skin near your ankle to help the nerves that control your bladder.

Will I know if I'm getting the real treatment or the dummy one?

No, you won't know during the study. This is important for the research to be fair and accurate. It's called 'blinding'.

How long will I need to have the treatment for?

If you're in the study, you'll have 30-minute treatment sessions daily for 12 continuous weeks.

How to find out more

Xavier Biardeau, MD

xavier.biardeau@chru-lille.fr 03.20.44.41.73 Official trial record

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