NeoTract has presented 5-year data from a clinical trial of its UroLift device. The data link the device to sustained effects on lower urinary tract symptoms, including improved peak urinary flow rate and quality of life.
Researchers presented data from the study of 206 patients with enlarged prostates at the annual American Urological Association meeting. The trial randomized 140 patients to be given UroLift, a device designed to alleviate lower urinary tract symptoms by stopping the prostate from blocking or narrowing the urethra. Other participants underwent a sham procedure.
Earlier data drops linked the device to fast improvements in peak urinary flow rate, performance on the International Prostate Symptom Score (IPSS) and in other areas.
The 5-year data show these gains mostly persist. IPSS after 5 years remained up 38% over the baseline reading, although this is a smaller improvement than seen in previous data drops. Qmax, the measure of maximum urinary flow rate, was also down on historic highs but still clocked in well above the baseline reading.
UroLift is performing as well as ever against other endpoints. The 5-year improvement against a quality of life measure came in at 54%, up on the 42% achieved one month after treatment and the figures from subsequent readouts. Participants' 5-year scores on the benign prostatic hyperplasia (BPH) impact index also matched up to those generated earlier in the study.
NeoTract sees the data furthering its ambitions for UroLift.
“The results continue to demonstrate the potential of the UroLift System to become the standard of care first-line treatment for patients with BPH. NeoTract has set the standard for robust BPH clinical data collection with global multi-site studies and proven durability and it’s an area we will continue to invest in,” NeoTract CEO Dave Amerson said in a statement.
NeoTract secured coverage of the device by Cigna earlier this month. That brought the proportion of the 40 million patients with BPH in the U.S. who can access UroLift up to 70%.