WAYNE, Pa., March 25, 2025 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced that new findings from the CLEAR study were presented at the 40th Annual European Association of Urology (EAU) Congress in Madrid, which took place March 21-24, 2025. Among the results, the study showed better early patient satisfaction and sexual function with the UroLift™ System (PUL) compared to Rezūm™ Water Vapor Therapy (WVTT).1
CLEAR is the first head-to-head randomized controlled trial (RCT) comparing early patient outcomes following treatment with UroLift™ PUL and Rezūm™ WVTT, two minimally invasive treatments for the symptoms of benign prostatic hyperplasia (BPH).1 The study provides critical insights into patient experience, safety, and efficacy, helping physicians and patients make informed treatment decisions.
“Comparative clinical trials play a crucial role in guiding treatment decisions for benign prostatic hyperplasia by providing clear, evidence-based insights into safety, efficacy, and patient experience,” said Dr. Matt Ashley, Associate Medical Director at Teleflex. “Understanding how these therapies perform not only in clinical settings but also in real-world patient recovery is essential. At Teleflex, we are committed to advancing research that supports the UroLift™ procedure as a trusted, patient-preferred option for BPH symptom treatment.”
Key Study Findings1:
- The primary endpoint of the study was catheter-independence between days three and seven post-procedure, measuring how quickly patients could recover without needing catheter support.
- Additional endpoints assessed critical factors such as patient satisfaction, sexual function, and the impact of the procedure on daily activities, including discomfort from pain or bleeding during urination.
- Among the 37 patients treated with Rezūm, 10 failed to achieve catheter-independence within the target timeframe, whereas only one out of 42 UroLift™ System patients failed to meet this benchmark.
- A greater proportion of patients who underwent treatment with Rezūm reported interference in daily activities due to pain while urinating and blood in urine, with these effects persisting at 14 days and one month post-procedure compared to those who received UroLift™ System.
- Sexual function outcomes favored the UroLift™ System, with significantly better scores in erectile and orgasmic function domains on the International Index of Erectile Function (IIEF) at one month, along with improved overall sexual satisfaction and ejaculatory function at three months.
- When assessing overall patient satisfaction, UroLift™ System patients consistently rated their experience more favorably. Composite satisfaction scores, which measure happiness with the procedure, satisfaction with voiding symptoms, and likelihood to recommend the treatment, were significantly higher for UroLift™ System patients at both 14 days and one-month post-procedure.
Mr. Mark Rochester, Consultant Urologist and Service Director for operating theatres at Norfolk and Norwich University Hospital and lead investigator on the CLEAR trial,* emphasized the significance of the findings:
“These results provide important insights into the real-world recovery experience of BPH patients undergoing minimally invasive treatments. The differences in patient experience between UroLift™ System and Rezūm, particularly in terms of early recovery, sexual function, and overall satisfaction, are key considerations for both clinicians and patients selecting a treatment path.”
For more information about the UroLift™ System, visit www.UroLift.com.
*Mark Rochester is a paid consultant of Teleflex.
About the UroLift™ System
The UroLift™ System is a minimally invasive treatment for lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). It is indicated for the treatment of symptoms of an enlarged prostate up to 100cc in men 45 years or older (50 years outside U.S.). The UroLift™ System permanent implants, which can be delivered during an outpatient procedure,2 relieve prostate obstruction without heating, cutting, destruction of, or removing prostate tissue. The UroLift™ System can be used to treat a broad spectrum of anatomies, including obstructive median lobe.3 It is the only leading BPH procedure shown to not cause new onset, sustained erectile or ejaculatory dysfunction.**4-5 A study conducted over 5 years showed a low retreatment rate of about 2-3% per year, or a total of 13.6% over the course of the study, demonstrating UroLift™ System durability.6 Most common side effects are temporary and can include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence.7 Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Individual results may vary. The prostatic urethral lift procedure (using the UroLift™ System) is recommended for the treatment of BPH in both the 2021 American Urological Association and 2022 European Association of Urology clinical guidelines. 500,000 men have been treated with the UroLift™ System in select markets worldwide.8 Learn more at www.UroLift.com.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
About Teleflex Incorporated
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose driven innovation, and world-class products can shape the future direction of healthcare.
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.
Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management’s current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.
Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. All other trademarks are the property of their respective owners.
© 2025 Teleflex Incorporated. All rights reserved.
References
**No instances of new, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal study
- Rochester, et al, EAU 2025. Results from the CLEAR RCT Suggest the Road to Recovery Is Not Equivalent Between UroLift PUL and Rezum WVTT†
- Shore, Can J Urol 2014
- Rukstalis, Prostate Cancer and Prostatic Dis 2018
- AUA BPH Guidelines 2003, 2020
- McVary, Urology 2019
- Roehrborn, Can J Urol 2017
- Roehrborn, J Urol 2013
- Management estimate based on product sales as of June 2024. Data on file Teleflex Interventional Urology.
†Study sponsored by Teleflex.
Contacts:
Teleflex
Lawrence Keusch
Vice President, Investor Relations and Strategy Development
[email protected]
610-948-2836
Media Contact:
Glenn Silver
Partner National Media Relations Specialist
[email protected]
646-871-8485
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