Active not recruitingOBSERVATIONAL

Registry for Patients Undergoing AUS Surgery for Female SUI Due to ISD

This study is gathering information about an operation called artificial urinary sphincter (AUS) surgery in women. This surgery is for a type of bladder leakage called stress urinary incontinence, which happens when the valve controlling urine flow from the bladder isn't working properly. Hospitals across Europe will be taking part, and they aim to collect details from around 150 women over two years. Everyone in the study will be followed for up to five years to see how well the surgery works in the long term. The main goal is to understand the effects of this surgery and improve care for women with this condition by collecting data on their quality of life, sexual health, and how well the treatment helps their bladder problems.

At a glance

Status

Active not recruiting

Sponsor

European Association of Urology Research Foundation

Enrolment target

180

Start

23 Jun 2020

Estimated completion

20 Apr 2026

Urinary Incontinence Urinary Incontinence, Stress Lower Urinary Tract Symptoms Urination Disorders Urologic Diseases

What is this study about?

This study is about an operation called artificial urinary sphincter (AUS) surgery. This surgery is for women who experience 'stress urinary incontinence'. This means they leak urine when they cough, sneeze, laugh, or exercise because the valve that holds urine in the bladder isn't working as it should. The study is collecting information from many hospitals across Europe to see how well this operation works for women with this specific problem.

Researchers want to understand how women's lives change after having this surgery. They will look at things like their bladder symptoms, their quality of life, and their sexual health. By gathering this detailed information from a large group of women over several years, they hope to learn more about the long-term effects of the surgery and if it helps women live more comfortably.

This kind of study, where information is collected from many patients in different places, helps doctors get a clearer picture of how a treatment works in the real world. It allows them to understand the benefits and challenges of the surgery better, which can then help improve care for other women in the future who need this operation.

Key takeaways

Study collects information on a specific bladder leakage surgery.
Aims to understand long-term effects of artificial urinary sphincter surgery.
Participants fill out questionnaires about their health and quality of life.
Involves women 18+ having their first AUS surgery for a weak bladder valve.
Data helps improve future care for women with this condition.
Your medical care won't change by being in the study.

Who may be eligible?

To be able to take part in this study, you must be a woman and at least 18 years old. You must also be planning to have (or are about to have) your very first artificial urinary sphincter (AUS) operation specifically for stress urinary incontinence, where your natural bladder valve isn't working correctly.

It's very important that you are happy to agree to join the study and are able to understand what it involves. You also need to be able to fill out some questionnaires about your health and how you are feeling.

This study is for women who are having this specific operation. If you are having a different kind of bladder surgery, or if your bladder leakage is for a different reason, then this study might not be suitable for you.

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 aged 18 or older?
Are you planning to have your first artificial urinary sphincter (AUS) operation?
Is your bladder leakage (stress urinary incontinence) due to a weak bladder valve?
Are you able and willing to fill out questionnaires?
Are you happy to give your permission to be part of the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't be given any new treatments or medicines specially for the study. Instead, the researchers will collect information about your health before and after your artificial urinary sphincter (AUS) operation. This information will come from the questionnaires you fill out about your bladder symptoms, quality of life, and sexual health.

You will continue to fill out questionnaires over a period of time after your surgery. The study plans to follow patients for up to five years from when the first person joined. This allows researchers to see how you are doing in the long term. Your doctors will explain exactly when you'll need to complete these questionnaires.

Potential risks and benefits

Taking part in this study won't change the medical care you receive, as you'll still have your planned surgery and follow-up as usual. While there aren't direct medical benefits from being in the study, your answers will help doctors learn more about this surgery and potentially improve care for other women in the future. The main 'risk' is the time it takes to fill out questionnaires, but all your information will be kept private. You are free to change your mind and leave the study at any time without it affecting your medical care.

Locations (19)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Universitair Ziekenhuis Gent
Verified postcode
Ghent, Belgium
University Hospital Leuven
Verified postcode
Leuven, Belgium
Thomayer Hospital
Verified postcode
Prague, Czechia
University Hospital Bordeaux
Verified postcode
Bordeaux, France
CHU de Lille
Verified postcode
Lille, France
CHU de Limoges
Verified postcode
Limoges, France
Hôpital Lyon Sud
Verified postcode
Lyon, France
Hôpital la Conception
Verified postcode
Marseille, France
Clinique urologique CHU de NANTES
Verified postcode
Nantes, France
University Hospital of Nimes
Verified postcode
Nîmes, France
Hôpital de la Pitié-Salpêtrière
Verified postcode
Paris, France
University of Rennes, Department of Urology
Verified postcode
Rennes, France

Common questions

What is 'Artificial Urinary Sphincter (AUS) Surgery'?

It's an operation to implant a device that helps control urine flow for women who leak urine due to a weak bladder valve.

What is 'stress urinary incontinence'?

It's when you accidentally leak urine during activities like coughing, sneezing, laughing, or exercising.

Will I have to take new medicine for this study?

No, this study doesn't involve any new medicines or treatments; it's simply collecting information about your usual care.

How long will I be involved in the study?

You'll be followed by the study for up to five years after the first patient joined, though your individual follow-up will depend on when you joined.

Will my personal details be kept private?

Yes, all the information collected from you will be kept confidential and private.