Mp27-09 Long Term Maintenance of Flow Rate Improvement After Treatment With Optilume BPH

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology II (MP27)1 May 2024MP27-09 LONG TERM MAINTENANCE OF FLOW RATE IMPROVEMENT AFTER TREATMENT WITH OPTILUME BPH Steven A. Kaplan Steven A. KaplanSteven A. Kaplan View All Author Informationhttps://doi.org/10.1097/01.JU.0001009400.86696.a2.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: 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. The PINNACLE study was a randomized, sham controlled study evaluating Optilume BPH against a sham procedure, with long-term follow-up limited to the active (Optilume BPH) treatment group. METHODS: 148 subjects were randomized in a 2:1 fashion (100 Optilume BPH, 48 sham) at 18 centers in the US and Canada. Subjects and evaluating personnel were blinded to the treatment received through 12-months, subjects randomized to receive treatment with Optilume BPH continued follow-up through 2 years. Symptom improvement was measured utilizing the International Prostate Symptom Score (IPSS), functional improvement measured by peak urinary flow rate (Qmax). Quality of life was assessed via IPSS QoL and BPH Impact Index (BPH-II). Erectile and ejaculatory function were evaluated utilizing the International Index of Erectile Function (IIEF) and the Men's Sexual Health Questionnaire - Ejaculatory Dysfunction (MSHQ-EjD). RESULTS: Seventy-eight subjects have completed the 2-year follow-up in the per-protocol set. A total of 2 subjects (2/100, 2%) have pursued additional surgical management (PAE, TURP) through the 2-year timepoint. Improvement in IPSS was maintained through 2 years (23.4 vs 10.5, ∆ -12.6). Qmax improved from 8.9 mL/sec at baseline to 19.0 at 12 months and was maintained at 18.7 mL/sec through 2-year follow-up. Paired analysis showed minimal changes in IPSS and Qmax from 12 month to 2 year follow-up. There were no changes in perceived sexual or ejaculatory function. CONCLUSIONS: Treatment with Optilume BPH results in impressive and durable functional improvements in flow rate and symptomology. Minimal surgical retreatment has occurred in the cohort of patients randomized to receive Optilume BPH as part of the pivotal randomized, sham controlled trial. Download PPT Source of Funding: Urotronic, Inc © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e426 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Steven A. Kaplan More articles by this author Expand All Advertisement PDF downloadLoading ...