Introduction: Data includes the initial 1 year EVEREST– I Study experience with the Optilume BPH Catheter System, with minimally invasive urethral prostatic balloon dilation, anterior commissurotomy and localized transfer of paclitaxel with a drug coated balloon (DCB) for treatment of lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH).
Methods: The prospective non-randomized study included 5 Latin American centers and 49 subjects treated with the Optilume BPH Catheter. Follow-up (f/u) included Foley removal, 2 weeks, 1, 3, 6 and 12 months (mo) post dilation. Baseline transrectal ultrasound included prostate measurement to size DCB catheter. Primary endpoints included International Prostate Symptom Score (IPSS) improvement of = 40% and major device or procedure related adverse events @ 3 mo. Secondary endpoints included 1) mean decrease of IPSS at each f/u, 2) change in peak urinary flow rate (Qmax) 3) change in post void residual urine volume (PVR) and 4) % of subjects with IPSS improvement = 30, 40, 50, and 75%.
Results: 75.5% of subjects had IPSS improvement of = 40% from baseline at 3 mo. Severe LUTS symptoms at baseline improved to mild or moderate. Average IPSS QOL improved through 12 mos. Qmax improved from 11 ml/sec at baseline to 19.4 ml/sec at 12 mo f/u. PVR decreased from 71.8 ml at baseline to 28.7 ml at 12 mos. BPH impact scores reported improved QOL through 12 mos. Prostatic DCB use had no significant effects on erectile function. One subject (2%) met the primary safety endpoint due to stress urinary incontinence.
Conclusions: Results demonstrate significant subjective and objective improvement in LUTS 2° to BPH. These data serve as a gateway to a pivotal trial versus sham now underway. Long term efficacy and safety will determine the role of the Optilume BPH Catheter as a therapy option for BPH. Source of