The Optilume BPH Catheter System is a novel Minimally Invasive Surgical Therapy (MIST) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). The Optilume BPH System utilizes mechanical dilation of the prostatic urethra to achieve an anterior commissurotomy while delivering the drug paclitaxel to maintain urethral patency. The EVEREST-I study is a prospective, single arm, multicenter study evaluating the safety and efficacy of the Optilume BPH System.

Key eligibility criteria included an International Prostate Symptom Score (IPSS) of ≥13, maximum flow rate (Qmax) of 5-15 mL/sec, and prostate volume 20-80g with no prior MIST or surgical intervention. Medication washouts included 3 weeks for alpha blockers and 6 months for 5 alpha-reductase inhibitors. Two-year follow up is ongoing, with 54 of 75 expected subjects with 2-year follow-up complete. The primary efficacy endpoint was responder rate, defined as the percent of subjects experiencing a ≥40% improvement in IPSS without receiving additional therapy. Other outcomes included IPSS, Qmax, and BPH Impact Index. Impact on sexual function was assessed by the International Index of Erectile Function (IIEF) and Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD).

A total of 80 men were enrolled and treated with the Optilume BPH Catheter System at 6 centers in Panama and the Dominican Republic. Subjects were an average of 65.8 years with prostate volume of 35.9g. The responder rate was 81.8% at 2 years which was consistent with 1-year results (81.3%, 61/75). Responder rate was consistent across all device sizes used. One subject received a prostatectomy 18 months post-treatment. IPSS improved from an average of 22.3 at baseline to 7.9 at 1 year and 8.3 at 2 years. Similarly, Qmax improved from 10.9 mL/sec at baseline to 18.3 mL/sec at 1 year and 17.7 mL/sec at 2 years. The IIEF Overall Satisfaction score was 7.2 at baseline and 7.9 at 2 years. Corresponding values for MSHQ-EjD were 9.4 and 9.1. There were no reported unanticipated adverse device effects.

Subjects in the study experienced significant and clinically meaningful improvements in symptom severity and voiding function that were sustained through 2 years. Quality of life improved concurrently. The treatment had no negative impact on sexual function as measured by IIEF and MSHQ-EjD. There was no control arm in this study, however a randomized controlled trial is ongoing to evaluate the safety and efficacy of the device. Long-term follow-up is planned through 5 years to further define the durability of the treatment.

The Optilume BPH System exhibited a significant improvement in both objective and subjective outcomes through 2-years post treatment. This minimally invasive approach shows promise as a treatment for LUTS secondary to BPH.