Published Data Demonstrate Consistent PUL Outcomes for the Treatment of Median Lobe Obstruction Across Controlled and Real-World Settings
Men with obstructive median lobes treated with the UroLift® System experience symptom improvement sooner and are satisfied more quickly compared to those treated with TURP, and have fewer post-op catheterizations
WAYNE, Pa., Oct. 25, 2022 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, announced today new data published in the peer-reviewed demonstrate the minimally invasive Prostatic Urethral Lift (PUL) procedure using the UroLift® System yields consistent safety, effectiveness and patient experience outcomes for 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® 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 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. Rx only.
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 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 .
Contacts:
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*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 2018
2. Roehrborn, Can J Urol 2017
3. AUA BPH Guidelines 2003, 2021
4. McVary, J Sex Med 2016
5. Roehrborn, J Urology 2013
6. Management estimate based on product sales as of April 2022. Data on file Teleflex Interventional Urology.
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