Published Data Demonstrate Sexual Function Improvement and Preservation with the Minimally Invasive UroLift® System Compared to Medications Prescribed for Benign Prostatic Hyperplasia

WAYNE, Pa., Jan. 20, 2021 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX) announced today that new data published in the peer-reviewed journal, , found that men treated with the Prostatic Urethral Lift (PUL) procedure (using the UroLift^® System) showed preservation and some improvement of sexual function compared to men being treated with medication for benign prostatic hyperplasia (BPH).

The comparative analysis “Prostatic Urethral Lift vs. Medical Therapy: Examining the Impact on Sexual Function in Men with BPH,” is the first study to longitudinally compare sexual function outcomes between major PUL studies^1-4 and data from the Medical Therapy of Prostatic Symptoms (MTOPS) trial. Treatment-related changes in sexual function were reported by validated patient questionnaires. In this comparison, researchers demonstrated that the UroLift System procedure maintained sexual function among sexually active men in all three domains (erectile function, ejaculatory function, and sexual satisfaction) that were examined, and even improved sexual function at certain timepoints. This was in contrast to daily treatment with an alpha blocker (doxazosin), 5-alpha-reductase inhibitor (finasteride), either alone or in combination with each other. This study was sponsored by Teleflex Incorporated.

“Within this comparative analysis examining the impact of PUL or medical therapy on male sexual health, we challenge the idea that medical therapy is the most conservative minimally invasive treatment option for BPH patients,” said Claus G. Roehrborn⁺, M.D., Urologist at the University of Texas Southwestern Medical Center and a lead author on the paper. “The results show that the sexual health preservation benefits provided by the UroLift System were not seen with medication. The UroLift System can provide rapid relief for the symptoms of BPH while sustaining and sometimes even improving sexual function.” 

Mean percent changes in erectile function, ejaculatory function, and sexual satisfaction from patient reported questionnaires were analyzed to determine improvements in sexual function. Key findings include:

• Following the UroLift System procedure, patients experienced a significant improvement in erectile function (17% at 1 year and 21% at 2 years). PUL was shown to be superior at preserving erectile function compared to medical therapy, specifically: doxazosin at 1 and 2 years, finasteride at 2 and 4 years, and combination therapy at 1 year.
  
   
• Men who received the UroLift System also experienced significant improvements in ejaculatory function over 4 years, with mean percentage changes from baseline in ejaculatory function score reaching 35%, 33%, 14%, and 18% at 1, 2, 3, and 4 years respectively. Conversely, men treated with finasteride or combination therapy experienced a decline in ejaculatory function. Among the drug therapy groups, combination therapy resulted in the greatest decrease in ejaculatory function, leading to a statistically significant reduction in the mean ejaculatory function score relative to baseline at 1 and 2 years of 17% and 13% respectively.
  
   
• Sexual satisfaction scores among patients treated with the UroLift System increased 22%, 21%, 19%, and 28% at 1, 2, 3, and 4 years respectively. In contrast, subjects treated with doxazosin, finasteride, or combination therapy experienced an overall decrease in sexual satisfaction during follow-up, however differences in mean percentage change from baseline were not statistically significant.

“This is an important study that highlights the unique benefits of the UroLift System in preserving sexual function in BPH patients,” said Tyler Binney, president of Teleflex Interventional Urology business unit. “In terms of sexual function, the UroLift System outperformed medications that are prescribed for BPH. These results indicate physicians can confidently recommend the UroLift System as a treatment option that can improve their patient’s quality of life, particularly in terms of sexual function and satisfaction.”   

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 US). The UroLift permanent implants, delivered during an outpatient procedure, may relieve prostate obstruction without cutting, heating, or removing prostate tissue. The UroLift System is the only leading BPH procedure shown to not cause new-onset, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal study.*^5-8 Most common adverse events are temporary and can include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence.¹ Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. As with any medical procedure, individual results may vary. Consult the Instructions for Use (IFU) for more information. 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. 200,000 men have been treated with the UroLift System in select markets worldwide.† Learn more at .

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.^6-8 Learn more at .

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 .

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. Roehrborn is a paid consultant of NeoTract | Teleflex Interventional Urology

________________________

1. Roehrborn, Can J Urol 2017

2. Rukstalis, BJU Int 2016

3. Rukstalis, Pros Ca Pros Dis 2019

4. McConnell, N Engl J Med 2003

5. Roehrborn, J Urology 2013 LIFT Study

6. AUA BPH Guidelines 2003, 2020

7. McVary, J Sex Med 2016

8. Berry, J Urol 1984

*No instances of new, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal study

† Management estimate based on product sales and average units per procedure

Contacts:

For Teleflex Incorporated:

Jake Elguicze, 610.948.2836

Treasurer and Vice President, Investor Relations

Media:

Nicole Osmer, 650.454.0504

MAC01811-01 Rev A