Teleflex Incorporated, a globally recognized leader in medical technologies, presented new research at the 2024 American Urological Association Annual Meeting in San Antonio, TX, highlighting the patient benefits of the Prostatic Urethral Lift (PUL) using the UroLift™ System for treating
benign prostatic hyperplasia (BPH). This year marks the first presentation of two randomized head-to-head trials that further cement the UroLift™ System as the premier minimally invasive surgical therapy (MIST) offering quick symptom relief and sustained results while preserving sexual function.
Jacqueline Welch, Vice President of Global Clinical and Scientific Operations at
Teleflex, emphasized the significance of these new studies and real-world analyses. She noted that Teleflex's decade-long commitment to advancing BPH research has facilitated more comprehensive discussions between clinicians and patients regarding treatment options.
Key findings from the studies were presented in several research sessions. The largest head-to-head randomized controlled trial (IMPACT) compared early patient outcomes between those treated with the UroLift™ PUL and those on
Tamsulosin medication. Preliminary data indicated that the UroLift™ system provided better symptom relief, quality of life improvements, and patient satisfaction within three months of treatment initiation.
Another key study, the first head-to-head RCT comparing the UroLift™ System and Rezūm (CLEAR), revealed that patients treated with the UroLift™ System experienced faster symptom relief and enhanced quality of life within the initial three months post-treatment compared to those undergoing water vapor thermal therapy (WVTT). This information can help healthcare providers and patients make more informed decisions about treatment options.
Additionally, a comprehensive analysis of post-surgery medication usage over five years among patients treated with the UroLift™ System, transurethral resection of the prostate (TURP), and GreenLight™ photoselective vaporization of the prostate (PVP) was presented. The analysis found similar medication usage rates among the three procedures over five years, indicating that not all TURP and PVP patients fully benefit from the interventions as anticipated.
A real-world analysis of hospitalizations and emergency department visits post-BPH surgical treatments showed that patients treated with UroLift™ PUL had the lowest number of unplanned visits. This real-world evidence highlights how minimally invasive and surgical therapies perform outside controlled clinical trials and provides crucial information for evaluating BPH treatment options.
A review of the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database of medical device reports (MDRs) demonstrated that the UroLift™ PUL had the lowest rates of mild, moderate, and severe complications on a per-case basis from 2019 to 2022. This underscores the safety and efficacy of the UroLift™ System compared to other invasive procedures like Aquablation®.
Dr. Claus Roehrborn, a professor of urology at UT Southwestern Medical Center and primary investigator on the study, highlighted the importance of the IMPACT study. He noted that the trial offers insights into patient journeys post-treatment with the UroLift™ System versus medication, allowing for better understanding of efficacy, patient satisfaction, and goal attainment.
In addition to presenting clinical data, Teleflex showcased the new UroLift™ 2 System with Advanced Tissue Control (ATC), recently cleared by the FDA. The UroLift™ 2 ATC System provides enhanced control of obstructive tissue, improved targeting accuracy, and increased physician comfort during procedures.
BPH is a common condition where the prostate enlarges with age, pressing on the urethra and causing urinary symptoms. The UroLift™ System offers a minimally invasive treatment option, helping men discontinue BPH medications and avoid major surgery while preserving sexual function. It is the only leading treatment that does not require heating, cutting, or destruction of prostate tissue.
The UroLift™ System is indicated for treating
lower urinary tract symptoms due to BPH in men aged 45 years or older. The system delivers permanent implants during an outpatient procedure, relieving
prostate obstruction without removing prostate tissue and showing durability with low surgical retreatment rates over five years. Common side effects are typically temporary and may include
hematuria,
dysuria, urgency,
pelvic pain, and
urge incontinence. Rare side effects like
bleeding and
infection may require intervention.
Teleflex remains committed to improving the health and quality of life through innovative medical technologies, offering a diverse portfolio in various therapy areas including anesthesia, emergency medicine, and urology.
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