Active not recruitingNAINTERVENTIONAL

Clinical Investigation to Assess a New Artificial Urinary Sphincter to Treat Urinary Incontinence in Women

This study is investigating a new type of artificial urinary sphincter, called UroMems, designed to help women who experience bladder leakage, also known as urinary incontinence. Many women find bladder leakage, particularly when they cough, laugh, or exercise, very troublesome and it can affect their daily lives. The study aims to find out how well this new device works and if it's a suitable long-term solution. Researchers want to see if it can effectively control leakage and improve quality of life for women who haven't found other treatments helpful. It's a key step in understanding if this new device could become a widely available treatment option.

At a glance

Status

Active not recruiting

Phase

Sponsor

UroMems SAS

Enrolment target

Start

02 May 2023

Estimated completion

01 Sep 2029

Urinary Incontinence,Stress

What is this study about?

You might be reading this because you (or someone you know) experience urinary incontinence, which is when you leak urine without meaning to. This can be very frustrating, especially when it happens during common activities like coughing, sneezing, laughing, or exercising – this type is often called stress urinary incontinence.

Doctors are always looking for better ways to help people with this condition. This particular study is about a new internal device, like a small implant, called the UroMems artificial urinary sphincter. Think of it like a tiny, gentle valve that helps control the flow of urine, aiming to prevent leaks. The purpose of this study is to see if this new device is a good and safe option for women who have tried other treatments for their bladder leakage with little success.

This is an important step in bringing new, effective treatments to patients. By taking part in studies like this, volunteers help doctors understand if new medical devices work as intended and if they can significantly improve people's lives. It's about finding solutions that offer more control and confidence for those affected by bladder leakage.

Key takeaways

Tests a new internal device for bladder leakage in women.
Aims to find a better solution when other treatments haven't worked.
Involves surgery to implant the device.
Requires regular follow-up and ability to operate the device.
Participation is voluntary; you can withdraw anytime.

Who may be eligible?

To be able to take part in this study, you need to be a woman over 18 years old. It's important that you fully understand what the study involves and are happy to give your permission to participate. You should also be able to follow instructions and attend appointments, which includes keeping track of any medicines you take and how much fluid you drink.

This study is specifically for women whose bladder leakage hasn't improved with other treatments, such as certain exercises or operations like slings. It's also important that your general health is good enough for surgery and you don't have certain other health conditions that might interfere with the study. Your doctor will check if your current medicines are stable and if you can safely use the new device.

There are also some reasons why you wouldn't be able to join. For example, if you're already in another medical study using a new device or drug, or if you've recently finished one. The study also can't include people who are unable to give their own consent or are under specific legal care.

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.

Are you a woman over 18 who leaks urine when you cough, laugh, or move?
Have other treatments for your bladder leakage not worked for you?
Are you generally healthy enough for surgery?
Are you able and willing to attend all study appointments and follow instructions?
Can you understand and agree to take part in the study?
Are you not currently involved in another medical study using a new device or drug?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be monitored closely. The new UroMems device will be surgically implanted. After the surgery, you'll have regular follow-up appointments and checks to see how well the device is working and how you're feeling. You'll need to keep a stable routine of any medications you take and your fluid intake, especially during the main part of the study. You'll also learn how to operate the device. The study will track your progress over time, so you'll need to be available for follow-up investigations as requested by the clinical team. The total length of your participation will depend on the study's design and your individual progress, but it involves monitoring over a significant period after the device is implanted.

Potential risks and benefits

Taking part in any study has potential benefits and risks. The main benefit here is that the new UroMems device might significantly improve your bladder control and quality of life if other treatments haven't worked for you. However, as with any surgery, there are risks like infection, bleeding, or issues related to the device itself. The research team will explain all known potential side effects. Remember, participation is completely voluntary, and you can withdraw from the study at any time without affecting your usual medical care.

Locations (2)

CHU Nantes
Verified postcode
Nantes, France
Groupe Hospitalier Pitié-Salpêtrière
Verified postcode
Paris, France

Common questions

What is an artificial urinary sphincter?

It's a small, internal device that helps control the flow of urine to prevent leaks, acting like a tap to open and close your bladder outlet.

Who is this study for?

It's for women aged 18 and over who have bladder leakage, especially when they move or cough, and haven't found other treatments helpful.

Will I have surgery if I join?

Yes, if you're suitable for the study, the new UroMems device will be implanted through surgery.

What if I don't want to continue the study?

You can leave the study at any time, and it won't affect your regular medical care.

Will I have to pay to be in the study?

Typically, clinical trials cover the costs related to the study device and appointments.