The Wayne, Penn.-based company said it presented data from seven studies of the UroLift system exploring its use for patients with benign prostatic hyperplasia at the World Congress of Endourology 2018 annual conference this week.
Results from a 156-patient real-world experience study comparing outcomes for BPH patients indicated improvements on the International Prostate Symptom Score, improved quality of life and peak flow rate at both three and six months post-treatment. At three months, patients reportedly experienced an average improvement of 10 points in IPSS, 2.2 points in QoL and 4.8ml in Qmax, the company said.
“The excellent results of this large study were consistent with the pivotal L.I.F.T. study. These outcomes demonstrate that the UroLift System can be used to treat patients with BPH in the real world safely and effectively,” study presenter Dr. Mark Rochester of the Norfolk and Norwich University Hospitals said in a prepared statement.
In a separate study evaluating the use of UroLift as a treatment for BPH in men with small and large prostate volumes, results indicated that such patients experienced statistically significant improvements in both symptoms and quality of life. At six months, mean IPSS was reported to decrease by 17.6 and 13.2, while quality of life improved 2.5 and 2.6 in the small and large prostate groups, respectively.
“Results from this study demonstrate the versatility of the UroLift System as an effective treatment for a wide range of patients and that it can be safely performed in an office setting. It is especially gratifying to see that results at an experienced center such as ours can meet or exceed those observed in the L.I.F.T. study,” study presenter Dr. Thomas Mueller of New Jersey Urology said in a prepared release.
Results from a study exploring patient outcomes and cost differences between treatment with UroLift and transurethral resection of the prostate indicated that patients treated with the UroLift system had hospital stays on average of 0.4 days, compared to 4.6 days for acute TURP and 1.8 days for elective TURP. Data also indicated that the use of the UroLift system reduced overall costs by 42% compared with TURP.
Data from a real-world study of the device comparing outcomes and cost between UroLift and TURP indicated that average costs between the two treatments were similar, but that no hospital stays or follow-up procedures were required with the UroLift, and that the procedure had a lower rate of complications. Estimates indicated a 50% reduction in complications and 50% adoption in patients who would otherwise undergo a TURP procedure, and approximate savings of $35.6 million (GBP £27 million) from reduced complications.
“The results of this study demonstrate that the UroLift System moves BPH procedures into day-case settings, achieving positive patient outcomes without financial investment or increased complications in patients with BPH. Data from this study also suggests that adoption of the UroLift System would increase overall capacity, allowing for healthcare centers to focus on critical cancer targets and waiting times, while reducing delays in both urgent and non-urgent surgery,” study presenter Dr. Oliver Kayes of Leeds Teaching Hospitals NHS Trust said in a press release.
The company also presented three additional real-world studies at the conference, touting that they showed favorable results for BPH patients who were treated with the UroLift system.
“The real-world results from these studies of diverse patient populations on three continents reaffirm the sustained benefits of the UroLift System as an accepted standard of care treatment for patients with BPH. We are pleased that we continue to see results from real-world studies in line with our randomized pivotal study, demonstrating that the UroLift System is a safe and effective minimally invasive treatment that offers men long-term relief from the symptoms of BPH,” NeoTract interventional urology biz unit prez Dave Amerson said in a press release.
In May, NeoTract said that the American Urological Association now recommends the use of NeoTract’s UroLift system as a standard of care treatment for lower urinary tract symptoms due to benign prostatic hyperplasia.
Registration is open for DeviceTalks Boston! Join us on June 5-6, 2019, as we explore the trends and technology that are shaping the future of the medical device industry.