Active not recruitingNAINTERVENTIONAL

Comparing UroLift Experience Against Rezūm

This study, called C.L.E.A.R., is looking at two common treatments for an enlarged prostate, known as Benign Prostatic Hyperplasia (BPH): UroLift and Rezūm. The main goal is to understand the patient's experience after having one of these procedures. Researchers will compare things like how many people need a temporary tube (catheter) after the treatment, whether they need more treatment later on, or if they need to start taking BPH medication again within 12 months. This research aims to help doctors and patients understand which treatment might be better for different people, focusing on real-life results and how the treatment affects daily living.

At a glance

Status

Active not recruiting

Phase

Sponsor

NeoTract, Inc.

Enrolment target

120

Start

22 Jan 2021

Estimated completion

01 Dec 2025

Benign Prostatic Hyperplasia

What is this study about?

When men get older, it's common for their prostate gland to get bigger. This is called Benign Prostatic Hyperplasia (BPH), and it can press on the tube that carries urine, causing problems like needing to go to the toilet more often or having trouble emptying the bladder fully. There are several ways to treat BPH, and two modern options are the UroLift System and the Rezūm System.

This study, called C.L.E.A.R., wants to compare how people feel and get on after having either the UroLift or Rezūm treatment. It's not just about how well the treatment works in a medical sense, but also about the patient's actual experience. Researchers will be especially interested in whether patients need a catheter after the procedure, how often they might need another treatment, or if they have to go back to taking medication for their prostate problems over the course of a year.

The idea is to get a clearer picture of what to expect from each treatment. By understanding the real-world experiences of patients, including how comfortable they are and how their symptoms improve, doctors can better advise men considering these options. This study will help provide important information to make informed decisions about BPH treatment.

Key takeaways

Compares UroLift and Rezūm for enlarged prostate (BPH).
Focuses on patient experience after treatment.
Looks at catheter use, repeat treatments, and medication needs for 12 months.
For men aged 50+ with BPH symptoms.
Involves questionnaires and check-ups over a year.

Who may be eligible?

To be considered for this study, you need to be a man aged 50 or over who has symptoms of an enlarged prostate (BPH). Your prostate gland should be a certain size, not too small and not too big, within the range of 30cm³ to 80cm³. You also need to be willing to read and sign a consent form that explains everything about the study.

There are also some reasons why you wouldn't be able to join. For example, if you currently have a urine infection, or if you already have a tube (catheter) to help you pee because you can't empty your bladder properly. Also, if you’ve had surgery on your prostate before, or if you have specific conditions with your water pipe (urethra) that might make the treatment difficult, you won't be able to take part.

Other reasons you might not be suitable include having severe blood in your urine, having certain implants like a urinary sphincter or a penile prosthesis, or if you are already taking part in another major medical research study.

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 symptoms of an enlarged prostate (BPH)?
Have you NOT had prostate surgery before?
Do you NOT currently have a urine infection?
Are you NOT dependent on a catheter for peeing?
Are you NOT currently in another major medical research study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to receive either the UroLift or Rezūm treatment for your enlarged prostate. After your procedure, if you need a temporary catheter, you will have a follow-up appointment to check how you are passing urine when the catheter is removed.

Throughout the study, you'll be asked to fill out questionnaires and have some health checks, which are part of the standard care for your condition anyway. These assessments will take place at several points after your procedure: on day 3, day 7, after 2 weeks, then at 1 month, 3 months, and finally at 12 months (one year). The study aims to follow your progress and experience over this 12-month period.

Potential risks and benefits

Taking part in this study could offer the benefit of receiving one of two modern treatments for an enlarged prostate under close medical supervision, with careful monitoring of your progress. However, all medical procedures carry some risks, which your doctor will explain in detail, such as potential discomfort, infection, or not fully resolving your symptoms. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (10)

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

Tower Urology
Verified postcode
Los Angeles, United States
Comprehensive Urology
Verified postcode
Royal Oak, United States
NYU Winthrop Urology
Verified postcode
Garden City, United States
Weil Cornell Medical College, Cornell University
Verified postcode
New York, United States
Urology Austin
Verified postcode
Austin, United States
UT Southwestern Medical Center
Verified postcode
Dallas, United States
Urology San Antonio
Verified postcode
San Antonio, United States
Frimley Park Hospital
Verified postcode
Frimley, United Kingdom
NORFOLK and Norwich University Hospital
Verified postcode
Norwich, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Verified postcode
Cambridge, United Kingdom

Common questions

What is BPH?

BPH stands for Benign Prostatic Hyperplasia. It means your prostate gland has become enlarged, which is common in older men and can cause urinary problems.

What are UroLift and Rezūm?

These are two different types of treatments for an enlarged prostate that aim to reduce urinary symptoms.

Will I know which treatment I'm getting?

No, you will be randomly assigned to either the UroLift or Rezūm treatment, like flipping a coin, so it's a fair comparison.

How long will I be involved in the study?

You'll be followed for 12 months (one year) after your procedure, with various check-ups and questionnaires during that time.

What does 'catheterization needs' mean?

This refers to whether you need a thin, flexible tube (a catheter) temporarily placed in your bladder after the procedure to help you pass urine, and for how long.