The purpose of this study was to gather initial safety and efficacy data with the Optilume BPH Catheter System for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).
A total of 80 men with moderate-to-severe LUTS secondary to BPH were enrolled and treated with the Optilume BPH Catheter System. Symptoms were evaluated using the International Prostate Symptom Score (IPSS) and Benign Prostatic Hyperplasia Impact Index (BPHII). Improvement in urinary flow and relief of obstruction was evaluated by way of peak urinary flow rate (Qmax) and postvoid residual urine volume (PVR). Subjects were prospectively queried for adverse events at each study visit, and relatedness to the study device were evaluated by the investigators, as well as centrally adjudicated by the study principal investigator.
Previous reports of symptom improvement in this cohort were maintained through four-year followup, with a significant reduction in IPSS and IPSS quality of life maintained through four years (-12.1, -2.8, respectively). Clinically meaningful improvement in Qmax was maintained in the majority of subjects, with an average improvement from baseline of +5.6 mL/sec. No treatment-related adverse events were reported in the long-term followup period.
Long-term followup through four years for subjects treated with the Optilume BPH Catheter System indicates durable outcomes in symptom improvement and functional improvement in flow rate. These results indicate the unique mechanism of action for Optilume BPH successfully achieves an immediate mechanical effect that is maintained long-term through incorporation of paclitaxel to maintain patency.
Canadian Urological Association journal = Journal de l'Association des urologues du Canada. 2024 Jun 17 [Epub ahead of print]
Steven A Kaplan, Merycarla Pichardo, Edwin Rijo, Gustavo Espino, Ramon Rodriguez Lay, Rafael Estrella
Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY, United States., URUS, Santo Domingo, Dominican Republic., Centro Médico Dr. Canela SRL, La Romana, Dominican Republic., Centro Especializado San Fernando, Panama City, Panama., Edificio Royal Center, Panama City, Panama., Clínica Unión Medica, Santiago de los Caballeros, Dominican Republic.