WAYNE, Pa.— May 18, 2020 — Teleflex Incorporated (NYSE: TFX) today announced that data from two analyses of the UroLift® System were presented at the American Urological Association (AUA) 2020 Virtual Science event. This new multimedia reinvention of the AUA 2020 poster and podium sessions was designed to connect and educate participants who are unable to gather as a result of the COVID-19 pandemic. Results from the analyses highlight the effectiveness of the minimally invasive treatment for benign prostatic hyperplasia (BPH) in preserving sexual function* and in a real-world setting.
“The UroLift System is an accepted standard of care treatment that provides rapid relief and recovery for men suffering from the burdensome symptoms of BPH,” said Dave Amerson, president of Teleflex Interventional Urology business unit. “Results from these analyses further support the use of this minimally invasive approach in the real-world as an alternative to BPH medications that often have unpleasant sexual side effects. The UroLift System allows many men to discontinue BPH medication and maintain – or even improve – their sexual function.”
The UroLift System is the only leading BPH procedure shown to not cause new onset, sustained erectile or ejaculatory dysfunction.*1-5
Results from a meta-analysis of patients’ sexual function following treatment with the UroLift System versus medical therapy were presented by Claus Roehrborn†, M.D., University of Texas Southwestern Medical Center. The analysis compared sexual function outcomes in 849 sexually active men from the MTOPS (Medical Therapy of Prostatic Symptoms) study who received daily treatment with an alpha blocker, 5-alpha-reductase inhibitor, either alone or in combination and 190 men from combined clinical studies of the UroLift System (L.I.F.T. pivotal trial; L.I.F.T. Crossover study; MedLift study) at 12, 24, 36 and 48 months.
Results from the analysis showed that patients treated with the UroLift System experienced significant improvements in ejaculatory function and erectile function at 12 and 24-months post-treatment. Patients also reported significant improvement in overall sexual satisfaction through 48 months post-treatment. In contrast, none of the medical therapies significantly improved patients’ erectile or ejaculatory function at any timepoint, and some therapies significantly reduced function. Patients taking finasteride reported a significant reduction in erectile function at 48 months, and patients that received a combination drug therapy experienced a significant reduction in ejaculatory function at 12 and 24 months.
The analysis revealed the UroLift System treatment was superior to finasteride and combination drug therapy at preserving erectile function at 12 and 24 months. Additionally, the UroLift System significantly outperformed all three medical therapies across all timepoints at preserving patients’ ejaculatory function. Only patients who received the UroLift System reported significant improvement in overall satisfaction in sexual life.
“Although not a head-to-head comparison, these results indicate that patients treated with the UroLift System achieved better outcomes in sexual function than men who received medical therapy,” said Dr. Roehrborn. “The UroLift System is a minimally invasive option for patients that may allow them to get off BPH medications and avoid sexual dysfunction. This is in line with the AUA clinical guidelines, recommending that patients be counseled about the sexual side effects of any BPH intervention.”
To assess the UroLift System performance in a real-world setting compared to experience in controlled settings, an analysis compared patient outcomes from the large Real World Retrospective (RWR) study to those found in the L.I.F.T. pivotal trial and P.U.L.S.A.R. urinary retention trial, which studied catheter dependent BPH patients. Results from the analysis were presented by Gregg Eure†, M.D., urologist at Urology of Virginia. The RWR study gathered data from 3,226 patients that were treated with the UroLift System across 22 international sites. For the analysis, patients from the real-world study were divided into non-urinary retention and urinary retention groups.
Results from the analysis showed patients from all groups experienced similar absolute International Prostate Symptom Score (IPSS) scores at all timepoints following treatment with the UroLift System. Analyses also revealed equivalent safety profiles among non-urinary retention and urinary retention patient groups from the real-world study when compared to corresponding groups in controlled studies. Finally, the results indicated that the majority of retention patients became catheter independent at the end of the studies – 84% in the RWR study and 73% in the P.U.L.S.A.R study.
“These findings demonstrate that patients treated with the UroLift System in a real-world setting experience consistent symptom response, safety, and overall patient experience to those treated in a controlled setting,” said Dr. Eure. “Clinicians should be encouraged not only by the consistency of the real-world results to those seen in clinical studies, but also by the positive outcomes found among BPH patients with urinary retention who are often excluded from clinical studies but are seen in a real-world clinic setting.”
About the UroLift® System
The FDA-cleared UroLift System is a proven, minimally invasive technology for treating lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). The UroLift permanent implants, delivered during a minimally invasive transurethral outpatient procedure, relieve prostate obstruction and open the urethra directly without cutting, heating, or removing prostate tissue. Clinical data from a pivotal 206-patient randomized controlled study showed that patients with enlarged prostate receiving UroLift implants reported rapid and durable symptomatic and urinary flow rate improvement without compromising sexual function.*1,6 Patients also experienced significant improvement in quality of life. Most common adverse events reported include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence. Most symptoms were mild to moderate in severity and resolved within two to four weeks after the procedure. The Prostatic Urethral Lift procedure using the UroLift System is recommended for the treatment of BPH in both the American Urological Association and European Association of Urology clinical guidelines. The UroLift System is available in many markets and over 175,000 men have been treated with the UroLift System worldwide**. Learn more at www.UroLift.com.
About Teleflex Interventional Urology
The Teleflex Interventional Urology Business Unit is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. Our focus is on improving the standard of care for patients with BPH using the UroLift System, a minimally invasive permanent implant system that treats symptoms while preserving sexual function.*6,7 Learn more at www.NeoTract.com.
About Teleflex Incorporated
Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit www.Teleflex.com.
Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rusch®, UroLift® and Weck® – trusted brands united by a common sense of purpose.
†Dr. Claus Roehrborn and Dr. Gregg Eure are paid consultants of NeoTract | Teleflex Interventional Urology.
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For Teleflex Incorporated:
Jake Elguicze, 610.948.2836
Treasurer and Vice President, Investor Relations
Nicole Osmer, 650.454.0504
1. Roehrborn, J Urology 2013 LIFT Study
2. AUA BPH Guidelines 2003, 2010, 2018
3. Naspro, Eur Urol 2009
4. Montorsi, J Urol 2008
5. McVary, J Sex Med 2016
6. Shore, Can J Urol 2014 Local Study
7. Speakman et al. 2014 BJUI International
* No instances of new, sustained erectile or ejaculatory dysfunction
**Management estimate based on product sales and average units per procedure
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