MP76-02 AT 4 YEARS, OPTILUME BPH HAS THE HIGHEST SUSTAINED IMPROVEMENT IN PEAK FLOW (QMAX) OF ANY MINIMALLY INVASIVE BPH THERAPY

Abstract

You have accessJournal of UrologyCME1 Apr 2023MP76-02 AT 4 YEARS, OPTILUME BPH HAS THE HIGHEST SUSTAINED IMPROVEMENT IN PEAK FLOW (QMAX) OF ANY MINIMALLY INVASIVE BPH THERAPY Steven Kaplan, Merycarla Pichardo, Edwin Rijo, Ramon Rodriguez Lay, Gustavo Espino, and Rafael Estrella Steven KaplanSteven Kaplan More articles by this author , Merycarla PichardoMerycarla Pichardo More articles by this author , Edwin RijoEdwin Rijo More articles by this author , Ramon Rodriguez LayRamon Rodriguez Lay More articles by this author , Gustavo EspinoGustavo Espino More articles by this author , and Rafael EstrellaRafael Estrella More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003350.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: 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, a novel minimally-invasive treatment for Benign Prostatic Hyperplasia (BPH). Optilume BPH utilizes mechanical dilation of the prostatic urethra to achieve an anterior commissurotomy while delivering the drug paclitaxel to maintain long-term urethral patency. METHODS: A total of 80 subjects were enrolled at 6 centers. Follow up is ongoing, with 32 of 72 expected subjects with 4-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). RESULTS: Mean Qmax showed an immediate increase from 10.9 mL/sec at baseline to 18.8 mL/sec at 14 days, which was sustained at 18.1 mL/sec through 4 years post treatment (p<0.001 vs baseline). A paired analysis of those subjects completing the 4-year visit showed a steady Qmax compared to 3-year outcomes (18.1 vs 18.8, p=0.54). IPSS and BPH-II showed significant, immediate improvement from baseline with this improvement maintained through the 4-year follow-up (Table 1). Erectile and ejaculatory function scores were not significantly changed from baseline through 4 years. CONCLUSIONS: The Optilume BPH Catheter System combines mechanical and pharmaceutical aspects for the treatment of BPH, resulting in both an immediate functional improvement by way of creating an anterior commissurotomy and a sustained anatomic result due to the application of paclitaxel to the prostatic urethra during the initial dilation. The functional and symptomatic improvements seen after treatment with Optilume BPH have been sustained through 4 years in this early feasibility study. The sustained improvement in Qmax is superior to any minimally invasive BPH device currently approved. Results from the EVEREST study will be further verified in the ongoing randomized, sham controlled PINNACLE study. Source of Funding: This study was funded by Urotronic, Inc © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1090 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Steven Kaplan More articles by this author Merycarla Pichardo More articles by this author Edwin Rijo More articles by this author Ramon Rodriguez Lay More articles by this author Gustavo Espino More articles by this author Rafael Estrella More articles by this author Expand All Advertisement PDF downloadLoading ...