Optilume BPH is a novel drug/device combination product that utilizes mechanical dilation of the prostatic urethra to achieve an anterior commissurotomy while delivering the drug paclitaxel to maintain long-term urethral patency. The EVEREST-I study is a prospective, single arm, multicenter study evaluating functional improvement in urine flow and improvement in lower urinary tract symptoms (LUTS) after treatment with the Optilume BPH System.
80 subjects were enrolled at 6 centers in Latin America. Follow up is ongoing, with 27 subjects with 5-year follow-up complete. Symptom improvement was measured utilizing the International Prostate Symptom Score (IPSS) and BPH Impact Index (BPH-II), functional improvement measured by peak urinary flow rate (Qmax) and post-void residual volume (PVR). Subjects receiving alternative therapy for BPH such as re-initiating medication therapy or surgical intervention were considered treatment failures and discontinued from further follow-up.
Three subjects (3/80, 3.8%) pursued additional BPH therapy (2 medication, 1 surgery) and were discontinued from further follow-up. Significant improvement was maintained in symptom scores, with IPSS improving an average of 10.2 points from baseline to 5 years. Quality of life metrics, including IPSS QoL and BPH-II, showed steady improvement from baseline. Functional improvement was also maintained, with an average baseline Qmax of 10.9 mL/sec improving to 20.6 mL/sec at the 5 year follow-up. A paired analysis of subjects completing both 4-year and 5-year follow-up identified no significant change for Qmax (18.2 mL/sec vs 20.6 mL/sec, p=0.19).
Treatment with Optilume BPH resulted in significant symptomatic and functional improvements that were sustained through long-term follow-up. These improvements were maintained with very limited rates of re-treatment, with only 1 surgical retreatment (1.3%) and 2 patients re-initiating BPH medications (2.5%). Optilume BPH represents a compelling and durable option for the minimally invasive treatment of LUTS secondary to BPH.
