Active not recruitingOBSERVATIONAL

Prospective Registry for Patients Undergoing Surgery for Male Stress Urinary Incontinence

This European study is collecting information from men undergoing surgery for urinary leakage, known as stress urinary incontinence. Specifically, it's looking at two common surgical options: an artificial urinary sphincter (a device that helps control urine flow) and a male sling (a mesh device that supports the urethra). Doctors want to understand how effective these surgeries are in helping men regain bladder control and reduce or stop urine leakage. By gathering data from many hospitals over several years, they aim to get a clear picture of how these treatments perform in the long run. This information will help improve care for future patients experiencing similar issues.

At a glance

Status

Active not recruiting

Sponsor

European Association of Urology Research Foundation

Enrolment target

1,054

Start

22 Feb 2017

Estimated completion

01 Jul 2027

Urinary Incontinence, Stress

What is this study about?

Imagine your bladder is like a balloon that holds urine, and a small valve, or sphincter, keeps the urine inside. If this valve becomes weak, especially when you cough, sneeze, laugh, or lift something heavy, you might leak urine – this is called stress urinary incontinence. This study focuses on men who experience this problem and are having surgery to fix it.

There are two main types of surgery this study is looking at: an artificial urinary sphincter (AUS) and a male sling. An AUS is like a tiny, inflatable cuff placed around the tube that carries urine out of the body (the urethra). You can control it with a small pump hidden under the skin to open or close it. A male sling is a piece of mesh material that gently lifts and supports the urethra, helping it stay closed when you don't want to urinate.

Doctors across Europe are working together to collect information from men who have these operations. They want to see how well these surgeries work over many years – how many men stop leaking urine, how many need fewer pads, and how long the benefits last. By sharing information from various hospitals, they can get a more complete and reliable picture to help improve advice and treatment for men with urine leakage in the future.

Key takeaways

This study helps doctors learn more about male urine leakage surgery.
It focuses on two operations: artificial urinary sphincters and male slings.
Data will be collected from many hospitals across Europe.
The study aims to see how well these surgeries work over many years.
Your participation helps improve future care for men with this condition.

Who may be eligible?

This study is for men who are going to have surgery for stress urinary incontinence. This means you leak urine when you cough, sneeze, or do other activities that put pressure on your bladder. You must be having one of two specific operations: either an artificial urinary sphincter or a male sling.

To be included, you need to be willing and able to fill in questionnaires about your health and experience. You also need to give your permission (called 'informed consent') to participate in the study, meaning you understand what's involved and agree to take part.

You cannot join the study if the hospital where you're having your surgery isn't able to enroll everyone who meets the criteria. This study aims to include every eligible patient at participating hospitals to get the most accurate information possible.

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 man who leaks urine when you cough, sneeze, or exercise?
Are you having surgery for this urine leakage?
Is your planned surgery either an artificial urinary sphincter or a male sling?
Are you willing to fill out questionnaires and give permission to use your information?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, it mainly involves your doctors collecting information about your surgery and how you recover. You won't need to take any extra medication or make additional visits specifically for the study. The doctors will gather important details like your age, weight, and how well you manage your urine leakage before and after your operation.

After your surgery, they will keep track of your progress over many years. This includes how long you remain free from urine leakage and whether you still need to use pads. This information will be collected during your regular follow-up appointments with your surgeon. The total duration of your participation in terms of data collection will be long-term, potentially up to 10 years or more, as the study aims to track results for an extended period.

Potential risks and benefits

There are no direct medical risks from participating in this study, as it primarily involves collecting information from your regular care. The main benefit is that your information will help doctors understand which surgeries work best for urine leakage and for how long. This can improve care for many men in the future. There's always a chance that the surgery itself might not work for everyone, or you could experience side effects commonly associated with surgical procedures, but these are risks of the surgery, not the study. Remember, you can decide to stop participating at any time without affecting your medical care.

Locations (28)

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

University Hospital Antwerpen
Verified postcode
Antwerp, Belgium
University Hospital Gent
Verified postcode
Ghent, Belgium
Jessa Ziekenhuis campus Salvator
Verified postcode
Hasselt, Belgium
AZ Groeninge
Verified postcode
Kortrijk, Belgium
UZ Leuven
Verified postcode
Leuven, Belgium
Thomayer Hospital
Verified postcode
Prague, Czechia
Helsinki University Hospital
Verified postcode
Helsinki, Finland
University Medical Center Hamburg Eppendorf
Verified postcode
Hamburg, Germany
Universitätsmedizin Mainz
Verified postcode
Mainz, Germany
University Münster
Verified postcode
Münster, Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Verified postcode
Rome, Italy
UMC Radboud
Verified postcode
Nijmegen, Netherlands

Common questions

What is 'stress urinary incontinence'?

It's when you leak urine accidentally, often when you cough, sneeze, laugh, or exercise, due to weakness in the muscles that hold urine in.

What's an 'artificial urinary sphincter'?

It's a small device implanted inside your body that you can open and close to control when you urinate, helping to stop leaks.

What's a 'male sling'?

It's surgery to place a mesh support under your urethra (the tube urine passes through) to help keep it closed and prevent urine leakage.

Will I have extra appointments if I join this study?

No, your doctors will collect information during your routine check-ups after your surgery, so you won't need any additional visits.

How long will my information be collected?

The study aims to track results for a long time, potentially up to 10 years or more, using information from your regular medical follow-ups.