Five-year results of the Phase 3 LIFT trial evaluating the safety and effectiveness of NeoTract’s UroLift System as a treatment for lower urinary tract symptoms (LUTS) in patients with symptomatic benign prostatic hyperplasia (BPH) showed stable, long-term relief.
Claus Roehrborn, MD, professor and chair of the Department of Urology at UT Southwestern Medical Center in Dallas, Texas, and co-principal investigator for the LIFT clinical program, presented the study’s results at the American Urological Association’s (AUA) annual meeting in Boston. They also were published in a report titled, “5 Year Prospective, Randomized, Controlled Study Results On The Minimally Invasive Prostatic Urethral Lift (PUL),” in The Journal of Urology.
“The results continue to demonstrate the potential of the UroLift System to become the standard of care first-line treatment for patients with BPH,” Dave Amerson, NeoTract president and CEO, said in a press release. “We are honored to partner with urologists around the world to help men return to normal urinary function and preserve sexual vitality with this safe and effective treatment option.”
Conducted in 19 centers in North America and Australia, with 206 men with symptomatic LUTS, the LIFT study (NCT01294150) evaluated patient outcomes for five years after Prostatic Urethral Lift (PUL) treatment involving the permanent placement of UroLift implants.
This procedure was shown to be highly tolerable and minimally invasive. Symptoms generally dissipated quickly, and sexual function was preserved. Evaluation of patients’ international prostate symptom score (IPSS) and peak urinary flow rate (Qmax) revealed that throughout the five-year follow-up, participants showed 36% and 44% improvement from baseline, respectively.
The procedure appears to be a durable treatment for LUTS, with a 2-3% per year retreatment rate and positive effects on patients’ quality of life, which showed a 50% improvement over the trial’s five-year period.
“The UroLift System has now been proven as a minimally invasive alternative to medication that offers sustained, reliable relief for patients,” said Steven Gange, MD, of Summit Urology Group in Salt Lake City, Utah, who treated numerous patients as a part of the LIFT trial.
Unlike other BPH treatments, this procedure requires little anasthesia or pain medication, and does not involve cutting, heating, or tissue removal. Healing and recovery are swift, with patients experiencing symptom relief and improved quality of life within a matter of days or weeks, Gange said.
“I truly believe the UroLift System is a game-changer for the field of urology,” he added. UroLift has been approved by the U.S. Food and Drug Administration.