Published Data Demonstrate Consistent PUL Outcomes for the Treatment of Median Lobe Obstruction Across Controlled and Real-World Settings
October 25 2022 - 6:30AM
Teleflex Incorporated (NYSE: TFX), a leading global provider of
medical technologies, announced today new data published in the
peer-reviewed Journal of Endourology demonstrate the minimally
invasive Prostatic Urethral Lift (PUL) procedure using the UroLift®
System yields consistent safety, effectiveness and patient
experience outcomes for benign prostatic hyperplasia (BPH) with and
without obstructive median lobes.
The comparative analysis, “Prostatic Urethral Lift
for Obstructive Median Lobes: Consistent Results Across Controlled
Trial and Real-World Settings,”* is the first to assess the
UroLift® System in both clinical settings and compare safety,
symptom, and patient experience outcomes to transurethral resection
of the prostate (TURP) and sham treatments in controlled
settings.
“This analysis reinforces that the UroLift® System
is an effective treatment option for men with BPH in prostates with
and without obstructive median lobes,” said Gregg Eure, M.D.,
Urologist at Urology of Virginia* and a lead author on the paper.
“Research directly comparing minimally invasive surgical procedures
for BPH has been sparse, but by comparing results from randomized,
controlled clinical trials and large real-world studies, we are
able to achieve a robust view of the safety and effectiveness of
PUL in treating obstructive median lobes and lateral lobe
obstruction.”
Controlled clinical trial results of the UroLift®
System for obstructive median lobes reveal that men who underwent
PUL experienced better symptom improvement within the first three
months of treatment compared to those treated with sham and TURP in
other controlled studies, and did not endure high grade serious
adverse events. Ejaculatory function scores for men treated with
the UroLift® System were also significantly better than TURP at all
timepoints.
PUL for obstructive median lobes in a real-world
setting confirms controlled clinical trial results following
treatment with the UroLift® System. Symptom and uroflow outcomes
were largely consistent for obstructive median lobe patients
treated in controlled and real-world settings; however, patients
treated in a real-world setting experienced fewer post-operative
catheterizations without elevated adverse events. Furthermore,
real-world safety, symptom and patient experience outcomes were
equivalent between men with lateral and median lobe
obstruction.
The comparative analysis included patients across 3
controlled clinical studies, including the 5 year L.I.F.T. Trial
and MedLift, an FDA-approved IDE extension of L.I.F.T., and 1 real
world retrospective study. Specifically, outcomes of obstructive
median lobe patients treated with the UroLift® System in controlled
(the MedLift study, n=45) and real-world settings (i.e., the
real-world retrospective study of the UroLift® System, n=180) were
evaluated against comparator groups (subjects without obstructive
median lobe treated with TURP [n=35] and sham [n=66] in randomized
controlled trials) to assess consistency in safety, symptom
response and patient experience. The L.I.F.T. study has proven
UroLift® System durability out to 5 years with a surgical
retreatment rate of 13.6% over 5 years or about 2-3% per year.
2
“This is the kind of comparative data that
urologists and men with BPH need to make informed choices about
their treatment,” said Kevin Hardage, President and General Manager
of Teleflex Interventional Urology. “By weighing a wide range of
controlled and real-world data, this vital analysis paints a broad
picture of the safety and effectiveness of the UroLift® System for
men with obstructive median lobes, and further shows significant
advantages compared to TURP. These results give urologists and
their patients increased confidence in the UroLift® System for the
treatment of BPH.”Key findings of the comparative analysis
include:
- UroLift® System vs
sham: Subjects in the MedLift study experienced 170%
greater symptom improvement at three months post-procedure to sham
subjects in the L.I.F.T. study.
- UroLift® System vs
TURP: Subjects in the MedLift study had significantly
greater improvement (i.e., IPSS point change from baseline) at one
and three months, and similar improvement at six and 12 months to
TURP subjects in the BPH6 trial. Significantly more MedLift
subjects were satisfied sooner after treatment (one and three
months), while a similar rate of patient satisfaction was observed
between MedLift and TURP subjects at six and 12 months
post-treatment. Ejaculatory function and bother scores were
significantly better for MedLift subjects at all time points.
- Controlled vs real-world outcomes: Symptom
improvement was equivalent among MedLift study subjects and the
filtered real-world obstructive median lobe group at three, six,
and 12 months post-treatment.
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 100 cc in men 45 years or older (50 years outside U.S.). The
UroLift® permanent implants, which can be delivered during an
outpatient procedure, 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.1 It is the only leading BPH
procedure shown to not cause new onset, sustained erectile or
ejaculatory dysfunction.**2-4 The L.I.F.T. study has proven
UroLift® System durability out to 5 years with a surgical
retreatment rate of 13.6% over 5 years or about 2-3% per year.2
Most common adverse events are temporary and can include hematuria,
dysuria, micturition urgency, pelvic pain, and urge incontinence.5
Rare side effects, including bleeding and infection, may lead to a
serious outcome and may require intervention. Individual results
may vary. 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. More than 350,000 men have been treated with
the UroLift® System in select markets worldwide.6 Learn more at
UroLift.com. Rx only.
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 access, interventional cardiology and
radiology, anesthesia, emergency medicine, surgical, urology 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.com.
Contacts:Teleflex
Incorporated:Lawrence KeuschVice President,
Investor Relations and Strategy DevelopmentJohn Hsu,
CFAVice President, Investor
RelationsInvestors.teleflex.com610-948-2836Media:Nicole
Osmernicole@healthandcommerce.com 650-454-0504
*The study was sponsored by Teleflex Interventional
Urology, and the authors, Drs. Gregg Eure, Claus Roehrborn, and
Daniel Rukstalis, are paid consultants of Teleflex.**No instances
of new, sustained erectile or ejaculatory dysfunction in the
L.I.F.T. pivotal study.
References:1. Rukstalis, Prostate
Cancer and Prostatic Dis 20182. Roehrborn, Can J Urol 20173. AUA
BPH Guidelines 2003, 20214. McVary, J Sex Med 20165. Roehrborn, J
Urology 20136. Management estimate based on product sales as of
April 2022. Data on file Teleflex Interventional Urology.
Teleflex is the home of Arrow®, Deknatel®, LMA®,
Pilling®, QuikClot®, Rüsch®, UroLift®, and Weck® – trusted brands
united by a common sense of purpose.© 2022 Teleflex Incorporated.
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