Active not recruitingOBSERVATIONAL

Optilume Registry for Treatment of Stricture of the Anterior Urethra

This study, called the Optilume Registry, is looking at how well a treatment for a common male urinary problem, called an anterior urethral stricture, is working in real-world use. A stricture is a narrowing in the tube (urethra) that carries urine out of the body. The treatment uses a special balloon coated with medication, called Optilume, to widen the narrowed area. Researchers want to make sure this treatment continues to be safe and effective for patients who have ongoing issues with their urethra. If you participate, you'll have the standard Optilume procedure and then attend follow-up appointments over several years to check your progress and provide feedback on how you're doing.

At a glance

Status

Active not recruiting

Sponsor

European Association of Urology Research Foundation

Enrolment target

150

Start

13 Oct 2022

Estimated completion

15 Aug 2029

Anterior Urethral Stricture, Male

What is this study about?

This study is called the Optilume Registry and it focuses on a condition called an anterior urethral stricture. This is when the tube that carries urine out of your body (the urethra) becomes narrow, which can make it difficult and uncomfortable to pass urine. This condition is common in men.

The Optilume treatment involves a special balloon coated with a medicine. This balloon is carefully inserted into the narrowed part of the urethra and inflated to gently widen it. The medicine on the balloon helps to prevent the stricture from coming back. This study isn't testing a new treatment; rather, it’s keeping an eye on patients who are already receiving this treatment as part of their routine care. The main goal is to collect information over time to confirm that the Optilume treatment continues to be both safe and effective for patients facing this issue.

By gathering information from many patients, researchers can gain a better understanding of the long-term success and any potential side effects of the Optilume treatment. This helps doctors and patients make informed decisions about managing anterior urethral strictures, ensuring the best possible care for the future.

Key takeaways

This study tracks the long-term safety and effectiveness of the Optilume treatment for urethral strictures.
It's for men aged 18+ with a specific type of recurrent urethral narrowing.
Participation involves your standard Optilume procedure followed by clinic visits for up to 5 years.
The study helps doctors understand patient outcomes in real-world settings.
You can withdraw from the study at any point without impacting your care.

Who may be eligible?

To be able to take part in this study, you need to be a male aged 18 or over. You must have been diagnosed with a recurrent narrowing (stricture) in the front part of your urethra that's 3cm or less in length, and your doctor plans to treat this using the Optilume balloon.

It's also essential that you're willing to understand and sign a consent form, and that you're able to come back for regular check-ups as part of the study.

You would not be able to join the study if you have ever had a severe allergic reaction to the medicine called paclitaxel (which is on the balloon) or similar drugs. Also, if you have had certain cancers of the urinary or reproductive system (like kidney, bladder, prostate, or testes cancer) that are not fully in remission, you unfortunately cannot participate. If you are unwilling to avoid unprotected sex for a short period after the procedure, or if your female partner is of childbearing age and you are unwilling to use effective contraception for 6 months, you would not be eligible.

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 male aged 18 or older?
Do you have a recurrent urethral stricture (narrowing) that your doctor plans to treat with Optilume?
Are you able to attend follow-up visits for several years?
Do you have any serious allergic reactions to paclitaxel or related drugs?
Do you have a history of cancer in your urinary or reproductive system that is not fully resolved?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will first receive full information about the study and be asked to sign a consent form. You will then undergo the Optilume treatment, which is a standard procedure to widen your urethral stricture using the special coated balloon.

After your treatment, you will need to return to the hospital for follow-up visits. These visits are planned for 3 months, 6 months, and 12 months after your procedure. Following that, you'll have annual check-ups for an additional 2 to 5 years. During these visits, the medical team will assess your progress. This may include filling out questionnaires, but only if that's already part of your usual care after this type of procedure.

Potential risks and benefits

As this study involves a procedure you would likely have anyway, the direct benefits are primarily for overall medical understanding. Your participation helps doctors learn more about the long-term effectiveness and safety of the Optilume treatment for others. Like any medical procedure, there are potential risks, which your doctor will explain in detail, including possible reactions to the medication on the balloon. You always have the right to withdraw from the study at any time without affecting your medical care.

Locations (13)

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

AZ Middelares
Verified postcode
Ghent, Belgium
Department of Urology - San Raffaele University
Verified postcode
Milan, Italy
AOU "Città della Salute e della Scienza" University of Turin
Verified postcode
Torino, Italy
AOUI Verona, Urology Unit
Verified postcode
Verona, Italy
Oslo university hospital Rikshospitalet
Verified postcode
Oslo, Norway
Marques de Valdecilla University Hospital
Verified postcode
Santander, Spain
Lyx I Instituto de Urología
Verified postcode
Madrid, Spain
Hospital Universitario de Navarra
Verified postcode
Pamplona, Spain
Epsom and St Helier Hospitals
Verified postcode
Carshalton, United Kingdom
Frimley Park Hospital, Frimley Health NHS Foundation Trust
Verified postcode
Frimley, United Kingdom
Freeman Hospital
Verified postcode
Newcastle upon Tyne, United Kingdom
Norfolk & Norwich University Hospital
Verified postcode
Norwich, United Kingdom

Common questions

What is an anterior urethral stricture?

It's a narrowing in the tube that carries urine out of the body in men, making it hard to pass urine.

Is Optilume a new experimental treatment?

No, Optilume is an approved treatment. This study is observing its long-term safety and effectiveness in patients already receiving it.

How long will I be followed in this study?

You will have follow-up visits for up to 5 years after your treatment.

Will I have to take new medication?

The Optilume balloon has medication on it, but you won't be given extra study medication to take at home.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without explaining why, and it will not affect your medical care.