Published Data Demonstrate Sexual Function Improvement and Preservation with the Minimally Invasive UroLift® System Compared...
January 20 2021 - 6:30AM
Teleflex Incorporated (NYSE: TFX) announced today that new data
published in the peer-reviewed journal, European Urology Focus,
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 studies1-4 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® SystemThe
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 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.6-8 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. Roehrborn is a paid consultant of NeoTract |
Teleflex Interventional Urology
________________________1. Roehrborn, Can J Urol
20172. Rukstalis, BJU Int 20163. Rukstalis, Pros Ca Pros Dis 20194.
McConnell, N Engl J Med 20035. Roehrborn, J Urology 2013 LIFT
Study6. AUA BPH Guidelines 2003, 20207. McVary, J Sex Med 20168.
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,
610.948.2836Treasurer and Vice President, Investor Relations
Media:Nicole Osmer,
650.454.0504nicole@healthandcommerce.com
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