Teleflex Announces Updated Clinical Study Data Presented at the European Association of Urology (EAU) Congress
Teleflex (NYSE: TFX) presented new findings from the CLEAR study at the 40th Annual European Association of Urology Congress in Madrid. The study, comparing UroLift™ System (PUL) with Rezūm™ Water Vapor Therapy (WVTT) for benign prostatic hyperplasia (BPH) treatment, revealed superior outcomes for UroLift™.
Key findings include:
- Only 1 out of 42 UroLift™ patients failed to achieve catheter independence within 3-7 days post-procedure, compared to 10 out of 37 Rezūm patients
- UroLift™ patients reported less interference with daily activities due to pain and blood in urine
- Better sexual function outcomes were observed in UroLift™ patients, with improved erectile and orgasmic function at one month
- Higher patient satisfaction scores were recorded for UroLift™ at both 14 days and one-month post-procedure
Teleflex (NYSE: TFX) ha presentato nuove scoperte dallo studio CLEAR al 40° Congresso Annuale dell'Associazione Europea di Urologia a Madrid. Lo studio, che confronta il sistema UroLift™ (PUL) con la terapia a vapore acqueo Rezūm™ (WVTT) per il trattamento dell'iperplasia prostatica benigna (BPH), ha rivelato risultati superiori per UroLift™.
I principali risultati includono:
- Solo 1 paziente su 42 trattati con UroLift™ non ha raggiunto l'indipendenza dal catetere entro 3-7 giorni dopo la procedura, rispetto a 10 pazienti su 37 trattati con Rezūm
- I pazienti UroLift™ hanno segnalato meno interferenze nelle attività quotidiane a causa di dolore e sangue nelle urine
- Risultati migliori della funzione sessuale sono stati osservati nei pazienti UroLift™, con una funzione erettile e orgasmica migliorata dopo un mese
- Punteggi di soddisfazione del paziente più elevati sono stati registrati per UroLift™ sia a 14 giorni che a un mese dopo la procedura
Teleflex (NYSE: TFX) presentó nuevos hallazgos del estudio CLEAR en el 40° Congreso Anual de la Asociación Europea de Urología en Madrid. El estudio, que compara el Sistema UroLift™ (PUL) con la Terapia de Vapor de Agua Rezūm™ (WVTT) para el tratamiento de la hiperplasia prostática benigna (BPH), reveló resultados superiores para UroLift™.
Los hallazgos clave incluyen:
- Solo 1 de 42 pacientes tratados con UroLift™ no logró alcanzar la independencia del catéter dentro de los 3-7 días posteriores al procedimiento, en comparación con 10 de 37 pacientes de Rezūm
- Los pacientes de UroLift™ informaron menos interferencia en sus actividades diarias debido a dolor y sangre en la orina
- Se observaron mejores resultados de función sexual en los pacientes de UroLift™, con una mejor función eréctil y orgásmica al mes
- Se registraron puntuaciones de satisfacción del paciente más altas para UroLift™ tanto a los 14 días como al mes después del procedimiento
Teleflex (NYSE: TFX)는 마드리드에서 열린 제40회 유럽 비뇨기과 학회에서 CLEAR 연구의 새로운 결과를 발표했습니다. 이 연구는 양성 전립선 비대증(BPH) 치료를 위해 UroLift™ 시스템(PUL)과 Rezūm™ 수증기 요법(WVTT)을 비교했으며, UroLift™가 우수한 결과를 보였습니다.
주요 발견 사항은 다음과 같습니다:
- UroLift™ 환자 42명 중 1명만이 시술 후 3-7일 이내에 카테터 독립성을 달성하지 못했으며, Rezūm 환자 37명 중 10명이 이에 해당했습니다.
- UroLift™ 환자들은 통증과 소변의 혈액으로 인해 일상 활동에 대한 방해가 적다고 보고했습니다.
- UroLift™ 환자에서 성 기능 결과가 더 좋았으며, 한 달 후 발기 및 오르가즘 기능이 개선되었습니다.
- UroLift™에 대한 환자 만족도 점수가 시술 후 14일 및 한 달 모두에서 더 높게 기록되었습니다.
Teleflex (NYSE: TFX) a présenté de nouvelles découvertes de l'étude CLEAR lors du 40ème Congrès Annuel de l'Association Européenne d'Urologie à Madrid. L'étude, comparant le système UroLift™ (PUL) à la thérapie à vapeur d'eau Rezūm™ (WVTT) pour le traitement de l'hyperplasie bénigne de la prostate (BPH), a révélé des résultats supérieurs pour UroLift™.
Les principales conclusions incluent:
- Un seul patient sur 42 traité par UroLift™ n'a pas réussi à atteindre l'indépendance du cathéter dans les 3 à 7 jours suivant la procédure, contre 10 sur 37 pour Rezūm.
- Les patients UroLift™ ont signalé moins d'interférences dans leurs activités quotidiennes en raison de la douleur et du sang dans les urines.
- De meilleurs résultats en matière de fonction sexuelle ont été observés chez les patients UroLift™, avec une amélioration de la fonction érectile et orgasmique après un mois.
- Des scores de satisfaction des patients plus élevés ont été enregistrés pour UroLift™ à la fois à 14 jours et un mois après la procédure.
Teleflex (NYSE: TFX) hat auf dem 40. Jahreskongress der Europäischen Urologie-Vereinigung in Madrid neue Ergebnisse aus der CLEAR-Studie vorgestellt. Die Studie, die das UroLift™-System (PUL) mit der Rezūm™-Wasserdampfterapie (WVTT) zur Behandlung der benignen Prostatahyperplasie (BPH) vergleicht, zeigte überlegene Ergebnisse für UroLift™.
Wesentliche Ergebnisse umfassen:
- Nur 1 von 42 UroLift™-Patienten konnte innerhalb von 3-7 Tagen nach dem Eingriff keine Katheterunabhängigkeit erreichen, im Vergleich zu 10 von 37 Rezūm-Patienten.
- UroLift™-Patienten berichteten von weniger Beeinträchtigungen im Alltag aufgrund von Schmerzen und Blut im Urin.
- Bessere sexuelle Funktionsresultate wurden bei UroLift™-Patienten beobachtet, mit verbesserter erektiler und orgastischer Funktion nach einem Monat.
- Höhere Patientenzufriedenheitswerte wurden für UroLift™ sowohl nach 14 Tagen als auch nach einem Monat nach dem Eingriff aufgezeichnet.
- Superior catheter independence rates: 41/42 UroLift patients vs 27/37 Rezūm patients
- Better sexual function outcomes with improved erectile and orgasmic function
- Higher patient satisfaction scores at 14 days and one month post-procedure
- Reduced post-procedure complications (less pain and bleeding)
- One UroLift patient failed to achieve catheter independence within target timeframe
Insights
The CLEAR study results represent a significant competitive advantage for Teleflex's UroLift™ System in the BPH treatment market. This first head-to-head randomized controlled trial against Rezūm™ showed superior outcomes for UroLift™ across multiple critical metrics.
Most notably, the catheter-independence data (41/42 UroLift™ patients vs. 27/37 Rezūm™ patients) demonstrates a clear recovery advantage. The reduced interference with daily activities and superior sexual function preservation (including better erectile and orgasmic function at one month) addresses key quality-of-life priorities for BPH patients.
These comparative advantages position Teleflex to potentially gain market share in the minimally invasive BPH treatment space. Comparative clinical evidence showing superiority over competing technologies typically translates to stronger product differentiation, more effective marketing messaging, and increased physician preference.
While this study focuses on early outcomes (up to 3 months), the consistent pattern of superior results across multiple endpoints strengthens UroLift's clinical positioning. For Teleflex's medical technology portfolio, these findings validate their BPH treatment approach and could drive increased adoption of the UroLift™ System among urologists seeking evidence-based options for their patients.
The CLEAR trial provides valuable clinical insights for BPH treatment decision-making. The statistically significant differences in early recovery metrics strongly favor the UroLift™ System over Rezūm™ therapy.
The markedly better catheter-independence rate (only one UroLift™ failure versus ten Rezūm™ failures) represents a meaningful clinical advantage that directly impacts patient comfort and complication risk. Catheter dependency is consistently among patients' most significant concerns when considering BPH procedures.
Particularly noteworthy are the sexual function outcomes. UroLift™ demonstrated superior preservation of erectile function, orgasmic function, and ejaculatory function—critical quality-of-life factors that often determine treatment selection for sexually active patients.
The composite satisfaction scores further validate UroLift's clinical advantages, with significantly higher ratings at both 14 days and one month post-procedure. These findings align with clinical experience suggesting faster symptomatic improvement and fewer post-procedure complaints with UroLift™.
For urologists weighing treatment options, this comparative evidence provides clear differentiation between these minimally invasive approaches, supporting UroLift™ as potentially offering superior early patient experience with fewer activity limitations due to pain or bleeding during the recovery period.
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
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
investor.relations@teleflex.com
610-948-2836
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glenn.silver@finnpartners.com
646-871-8485
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FAQ
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