NeoTract today released the results from 2 randomized studies of its UroLift system designed to treat benign prostatic hyperplasia, touting “excellent” durability after 4 years.
The data was presented at the American Urological Association’s 2016 annual meeting in San Diego this week.
“The clinical data presented at this year’s AUA conference show that treatment with the UroLift System offered men suffering from BPH a well-tolerated minimally invasive experience that provided uniquely rapid relief and a durable, sustained effect. We are proud to offer this safe and effective treatment option that can allow men to stop taking BPH medications and be treated with a simple procedure that does not carry the risk of sexual side effects common with other treatment options,” CEO Dave Amerson said in a press release.
Included in the presentations were 4-year follow up data from the pivotal, randomized Lift IDE study and 2-year data from the BPH-6 study which compared the UroLift system to transurethral resection of the prostate.
Data from the 206-patient mult-center Lift IDE study indicated rapid reduction of symptoms with low mobidity and preserved sexual function, 62% improved International Prostate Symptom and Qmax scores as well as a 52% increase in quality of life scores over 4-years, the company said.
“While prior data have shown that this treatment option offers rapid relief with low morbidity, the four-year L.I.F.T. study data demonstrate solid durability for a less invasive treatment option. After four years, over 86% of patients were free from seeking additional procedural treatment for BPH,” LIFT co-principal investigator Dr. Claus Roerhborn said in prepared remarks.
Data from the 2-year BPH-6 post-market study indicated more consistent response outcomes when compared arainst TURP, the most common surgical treatment for BPH. Results indicated equal ability to provide symptom relief with both treatments, with superior quality of recovery and sexual function compared to TURP.
The study reported that TURP treatment resulted into statistically superior improvements on the IPSS and Qmax, but no difference in quality of life improvements.
“While TURP is the most common treatment for symptoms caused by an enlarged prostate, the side effects can be significant and may cause men to postpone or refuse treatment altogether. The results of this study provided an overall assessment of the ability of UroLift to improve symptoms without compromising important aspects of health, such as sexual function. We were also delighted to see that UroLift demonstrated superior quality of recovery. These characteristics are of great importance to patients when deciding how to address their symptoms,” Dr. Jens Sønksen of the Danish Association of Urology said in a prepared statement.