Introduction: The PINNACLE study is a prospective, randomized, double-blind, sham controlled study evaluating the Optilume BPH System. Optilume BPH is a novel minimally invasive surgical therapy (MIST) that combines mechanical dilation with the delivery of paclitaxel for the treatment of lower urinary tract symptoms (LUTS) secondary to BPH. Mechanical dilation with Optilume BPH achieves an anterior commissurotomy, while delivery of paclitaxel is intended to maintain luminal patency during healing. Methods: 148 subjects were randomized in a 2:1 fashion at 18 centers in the US and Canada. Subjects and evaluating personnel were blinded to treatment through 12-months. 12-month follow-up is 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). Erectile and ejaculatory function were evaluated utilizing validated questionnaires. Adverse events were prospectively collected and relatedness to treatment was adjudicated by an independent, blinded clinical events committee. Results: Subjects treated with Optilume BPH showed a significant reduction in IPSS through 12 months (23.4 vs 10.9, p<0.001). Improvement in IPSS at 12 months was significantly greater for Optilume BPH compared to Sham in the intent-to-treat population (11.5 vs 4.8, p<0.001). Qmax more than doubled from 8.9 mL/sec at baseline to 19.0 mL/sec after treatment with Optilume BPH, while average PVR decreased from 84 mL to 58 mL (p=0.004). There were no changes in perceived sexual or ejaculatory function. The most reported treatment related adverse events after treatment with Optilume BPH included hematuria (39/98 [39.8%]), urinary tract infection (11/98 [11.2%]), and dysuria (8/98 [8.2%]). Conclusions: Treatment with Optilume BPH resulted in significant, immediate symptomatic and functional improvements and to date the highest Qmax reported in BPH MIST trials. Durability of these outcomes was shown through 12 months follow-up, demonstrating the intended effect of an immediate mechanical benefit that is sustained long-term by the delivery of paclitaxel. Long-term outcomes will be verified with 5 year follow-up for Optilume BPH. SOURCE OF Funding: Urotronic, Inc.
