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® SystemThe 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 UrologyThe
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 IncorporatedTeleflex 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.
Contacts:For Teleflex
Incorporated: Jake Elguicze, 610.948.2836 Treasurer and Vice
President, Investor Relations Media: Nicole Osmer, 650.454.0504
nicole@healthandcommerce.com
1. Roehrborn, J Urology 2013 LIFT Study2. AUA BPH Guidelines
2003, 2010, 20183. Naspro, Eur Urol 20094. Montorsi, J Urol 20085.
McVary, J Sex Med 2016 6. Shore, Can J Urol 2014 Local Study7.
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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