Teleflex Incorporated (NYSE: TFX) has announced compelling new clinical data for its UroLift™ System, reinforcing its advantages as a minimally invasive treatment for benign prostatic hyperplasia (BPH). The findings, presented at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, demonstrate superior early patient outcomes compared to alternative treatments.
Superior Results in Head-to-Head Trials
Two randomized controlled trials (RCTs) highlighted the UroLift System's advantages over both Rezūm Water Vapor Thermal Therapy (WVTT) and tamsulosin, particularly regarding early patient satisfaction, rapid symptom relief, and preservation of sexual function.
In the CLEAR RCT, which compared UroLift to Rezūm, patients treated with the UroLift System reported significantly higher satisfaction at both two weeks and one month post-procedure. The study showed that only one out of 42 UroLift patients failed to achieve catheter independence within the target timeframe, compared to 10 out of 37 Rezūm patients.
"These studies underscore our commitment to evidence-based innovation. The UroLift System continues to stand out as a patient-centered therapy offering meaningful improvements in symptoms and quality of life," said Claus Roehrborn, MD, professor of urology at UT Southwestern Medical Center and primary investigator on the studies.
Patients who received the UroLift procedure also experienced shorter catheterization times, better symptom relief, and superior sexual function outcomes during the early recovery period compared to Rezūm patients. Additionally, fewer UroLift patients reported interference in daily activities due to pain or blood in urine.
Medication vs. Minimally Invasive Procedure
The IMPACT RCT compared the UroLift System to tamsulosin, a commonly prescribed medication for BPH. At three months, men treated with UroLift showed significantly better symptom improvement compared to those taking medication. UroLift patients also reported better sexual function outcomes and overall experience.
Perhaps most telling was that 70% of men initially randomized to the medication treatment arm eventually chose to cross over to the UroLift System, suggesting strong patient preference for this minimally invasive option.
Real-World Evidence Supports Clinical Findings
Further validating these results, an analysis using the American Urological Association Quality Registry (AQUA) BPH dataset demonstrated that the UroLift System provides rapid symptom score improvement at three months. This real-world data corroborates evidence that BPH medications provide modest or no improvement compared to the more substantial benefits seen with the UroLift procedure.
Mark Rochester, Consultant Urologist and Service Director for operating theatres at Norfolk and Norwich University Hospital and lead investigator on the CLEAR trial, emphasized the significance of these findings: "The differences in patient experience between UroLift System and Rezūm, particularly in terms of early recovery, sexual function, and overall satisfaction, are key considerations for both clinicians and patients selecting a treatment path."
About the UroLift System
The UroLift System is a minimally invasive treatment for lower urinary tract symptoms due to BPH. It is indicated for men 45 years or older (50 years outside U.S.) with prostates up to 100cc. The procedure can be performed on an outpatient basis and works by placing permanent implants that relieve prostate obstruction without heating, cutting, or removing prostate tissue.
A key advantage of the UroLift System is that it is the only leading BPH procedure shown not to cause new onset, sustained erectile or ejaculatory dysfunction. A five-year study demonstrated durability with a low retreatment rate of approximately 2-3% per year, or 13.6% over the course of the study.
The UroLift System has been used to treat 500,000 men worldwide and is recommended in both the 2021 American Urological Association and 2022 European Association of Urology clinical guidelines.
Additional Research on Barrigel Rectal Spacer
Teleflex also presented findings on its Barrigel rectal spacer, used to protect the rectum during radiation therapy for prostate cancer. The study confirmed the safety of stabilized hyaluronic acid (sHA) rectal spacer in cases with rectal wall infiltration, demonstrating low risk of severe complications such as ulcers or fistulas.
"These findings reaffirm the safety profile of stabilized hyaluronic acid as a rectal spacer and highlight its reversibility as a distinct clinical advantage," said Michelle Svatos, director of Barrigel rectal spacer product development and research.
Implications for BPH Treatment
These latest clinical findings strengthen the evidence supporting the UroLift System as a preferred option for BPH treatment, particularly for patients seeking rapid symptom relief without compromising sexual function. The head-to-head comparisons with both medication and other minimally invasive procedures provide valuable information for clinicians and patients making treatment decisions.
As BPH affects approximately 50% of men by age 60 and up to 90% of men by age 85, these findings have significant implications for improving quality of life for millions of men worldwide.
