Optilume BPH Catheter System safe and efficacious for use in treating lower urinary tract symptoms in men

A recent study suggests that Optilume BPH Catheter System, a novel drug/device combination is a minimally invasive surgical therapy that is safe and efficacious for treating lower urinary tract symptoms secondary to benign prostatic hyperplasia. The results of this study were published in The Journal of Urology.

The PINNACLE study was a prospective, randomized, double-blind, sham-controlled trial in which 148 men who were 50 years or older, having symptomatic benign prostatic hyperplasia and a prostate size between 20 and 80 g, were enrolled. They were randomized in a 2:1 ratio to receive either Optilume BPH or a sham surgical procedure for a period of 1 year.

Those who were randomized to receive Optilume BPH (n=100) showed a reduction in International Prostate Symptom Score of 11.5±7.8 points after 1 year. Those on the sham surgical procedure (n=48) showed a reduction of 8.0±8.3 points at 3 months. In the Optilume BPH group, the flow rate was significantly improved (up to 125%) post-treatment.

From the above findings, it may be concluded that Optilume BPH provides immediate and sustained improvements in flow rate and obstructive symptoms and is thus, safe and effective for use in treatment of lower urinary tract symptoms in men.