A study evaluating NeoTract’s UroLift treatment for men with enlarged prostate glands showed a 62% improvement in lower urinary tract symptoms, the company said today.
The real-world study enrolled 100 men with benign prostatic hyperplasia (BPH) at a single center. Peak flow rate improved 140% and the post-void residual volume (PVR) decreased by 71 ml, with no patients requiring re-operation.
“Clinical data from previous studies have proven that the UroLift System offers rapid and durable relief of symptoms and improved quality of life for patients with BPH,” said principal investigator Bashar Omarbasha, M.D., chief of urology at Oneida Healthcare and Rome Memorial Hospital in Oneida, N.Y., in a prepared statement. “The results of this study, from my first 100 UroLift System patients, are even better than the pivotal L.I.F.T clinical study at the three-month follow up timepoint, adding to the clinical evidence that shows the UroLift System can be used in the real world safely and effectively.”
The UroLift permanent implants, delivered during a minimally invasive transurethral outpatient procedure, are designed to relieve prostate obstruction and open the urethra directly without cutting, heating, or removing prostate tissue. Other recent single-center studies have established that results from the L.I.F.T clinical study are being replicated by investigators in the real world, the company said. Among other sites, studies were conducted at Norfolk and Norwich University Hospitals NHS Foundation Trust U.K. and Yale New Haven Hospital, New Haven, Conn. NeoTract is based in Pleasanton, Calif.
“The results of these numerous real-world studies help to further validate the many advantages of the UroLift System for patients with BPH in the real world,” said Dave Amerson, president of the interventional urology unit of NeoTract’s parent company, Teleflex (NYSE:TFX). “We are proud to be improving the lives of patients suffering with the symptoms of BPH by providing a safe and effective treatment that provides rapid relief and allows men to stop or reduce BPH medications, without compromising sexual function.”
Clinical data from a pivotal 206-patient randomized controlled study showed that patients with enlarged prostate receiving UroLift implants reported rapid and durable symptomatic and urinary flow rate improvement without compromising sexual function. Patients also experienced a significant improvement in quality of life, the company said. Nearly 70,000 men have been treated with the UroLift System in the U.S.