RecruitingNAINTERVENTIONAL

Post-Market Study to Assess iTind Safety in Comparison to UroLift

This study is comparing two common treatments for men with an enlarged prostate, a condition called Benign Prostatic Hyperplasia (BPH). If you have BPH, your prostate gland can press on your urethra, the tube that carries urine, causing bothersome symptoms like needing to pee often or having a weak stream. The two treatments being looked at are called iTind and UroLift. Researchers want to understand which of these treatments is safer and works better at easing these urinary symptoms. Both iTind and UroLift are a type of procedure where doctors don't need to perform major surgery. The study aims to give clearer information to men and their doctors about the best options for managing BPH.

At a glance

Status

Recruiting

Phase

Sponsor

Olympus Corporation of the Americas

Enrolment target

206

Start

26 Sep 2022

Estimated completion

31 Dec 2031

Benign Prostatic Hyperplasia (BPH)

What is this study about?

This study is looking at two ways to treat a common problem in men called Benign Prostatic Hyperplasia, or BPH. This is when your prostate gland gets bigger as you get older, which can make it hard to pee properly. It might mean you need to go to the toilet a lot, especially at night, or your pee stream is weak. Both iTind and UroLift are treatments designed to help with these symptoms without needing major surgery.

The iTind device is a small, temporary implant that a doctor puts into the prostate for about 5 to 7 days. It gently reshapes the pee tube (urethra) over time, helping urine flow more easily. On the other hand, UroLift involves placing tiny implants permanently into the prostate. These implants pull back the enlarged parts of the prostate to create more space for urine to pass through.

Doctors want to compare these two options directly. They want to find out which treatment is safer and more effective at improving your urinary symptoms. By gathering this information, they can help men and their doctors make better choices about which treatment is right for them.

Key takeaways

Compares two treatments for enlarged prostate: iTind and UroLift.
Aims to find out which treatment is safer and more effective.
For men aged 50 or older with bothersome urinary symptoms.
Both treatments are minimally invasive, not major surgery.
Participation involves clinic visits and health checks over time.
You can stop participating at any point if you wish.

Who may be eligible?

This study is looking for men aged 50 or older who have bothersome urinary symptoms because of an enlarged prostate. To be considered, your prostate specific antigen (PSA) blood test result should be less than 4. If it's between 4 and 10, your doctor will need to confirm you don't have prostate cancer.

Your prostate size should be up to 75cc, and you should score 13 or more on a common questionnaire about prostate symptoms (IPSS). You also need to be able to pee with a certain flow rate – not too fast and not too slow – and provide enough urine for the measurement.

Unfortunately, you wouldn't be able to join if you've had prostate or bladder cancer recently, have certain nerve problems affecting your bladder, or have other bladder or urine tube conditions like a very narrow urethra. You also can't participate if your doctor thinks either the iTind or UroLift treatment isn't 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 man aged 50 or older?
Do you have problems peeing due to an enlarged prostate?
Is your PSA blood test result acceptable (e.g., under 4, or checked for cancer if between 4-10)?
Is your prostate gland size up to 75cc?
Do you have a symptom score (IPSS) of 13 or higher?
Have you not had prostate or bladder cancer recently?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll have several visits to the clinic so doctors can check on your health and how the treatment is working. These visits will include answering questionnaires about your symptoms, undergoing medical examinations, and providing urine samples to measure your flow rate. You may also have imaging tests to look at your prostate.

Your involvement will start with an initial check to see if you're suitable. After the treatment, you'll have follow-up appointments over a period of time to track your progress. The total length of your participation in the study will depend on the specific follow-up schedule designed to properly compare the treatments.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit of receiving one of two treatments for your enlarged prostate, which could improve your urinary symptoms. However, like all medical procedures, both iTind and UroLift carry potential risks, such as discomfort, bleeding, or infection, and these will be fully explained to you. There's also no guarantee that the treatment will work for you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (19)

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

Mayo Clinic Arizona
Verified postcode
Phoenix, United States· Recruiting
Arizona Urology Specialists
Verified postcode
Tucson, United States· Terminated
Urology Associates of Central California
Verified postcode
Fresno, United States· Recruiting
Golden State Urology
Verified postcode
Sacramento, United States· Recruiting
NorthShore University Health System Research Institute
Verified postcode
Evanston, United States· Terminated
Southeast Louisiana Veterans Health Care System
Verified postcode
New Orleans, United States· Recruiting
Minnesota Urology
Verified postcode
Woodbury, United States· Recruiting
Adult & Pediatric Urology
Verified postcode
Omaha, United States· Recruiting
Pacific West Urology
Verified postcode
Las Vegas, United States· Recruiting
Feinstein Institutes for Medical Research / Northwell Health
Verified postcode
Syosset, United States· Recruiting
The Conrad Pearson Clinic
Verified postcode
Germantown, United States· Recruiting
Midtown Urology Associates
Verified postcode
Austin, United States· Recruiting

Common questions

What is an enlarged prostate?

It's when the prostate gland, which is part of the male reproductive system, grows bigger as men get older, often causing problems with peeing.

What are urinary symptoms?

These can include needing to pee often, especially at night, having a weak or slow pee stream, or feeling like you can't completely empty your bladder.

Are iTind and UroLift major surgeries?

No, both are considered minimally invasive, meaning they involve smaller procedures compared to traditional open surgery.

What is a PSA test?

It's a blood test that measures Prostate Specific Antigen, a substance produced by the prostate. It can help doctors check prostate health.

Can I choose which treatment I get?

In a comparison study like this, the treatment you receive is usually decided randomly, like flipping a coin, to ensure a fair comparison.

How to find out more

Selen ZuelbaharOlgun, PhD

selen.zuelbaharolgun@olympus.com +1-650-586-2171 Official trial record

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