To evaluate the safety and efficacy of the Optilume BPH Catheter System for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).
This open-label, single-arm study enrolled eighty subjects with LUTS secondary to BPH who were treated with the Optilume BPH Catheter System. Symptoms were recorded utilizing the International Prostate Symptom Score (IPSS) and Benign Prostatic Hyperplasia Impact Index (BPH-II). Functional improvement was measured utilizing peak urinary flow rate (Qmax) and post-void residual urine volume (PVR). Adverse events were systematically captured and reported at each follow-up visit.
Subjects treated with the Optilume BPH Catheter System experienced a significant improvement in LUTS from baseline through 2 years of follow-up, as measured by IPSS (22.3 vs 8.2, p < 0.001) and BPH-II (6.9 vs 2.3, p < 0.001). Functional improvement was also significant, with Qmax improving from an average of 10.9 mL/s at baseline to 17.2 mL/s at the 2-year follow-up and PVR improving from 63.1 to 45.0 mL. Treatment-related adverse events were typically minor, with none occurring between 1- and 2-year post-treatment.
The Optilume BPH Catheter System is a unique minimally invasive surgical therapy that combines mechanical and pharmaceutical aspects for the treatment of BPH. The functional and symptomatic improvements seen after treatment are significant and have been sustained through 2 years in this early feasibility study.
NCT03423979, registered February 6, 2018.
World journal of urology. 2023 Jun 24 [Epub ahead of print]
Merycarla Pichardo, Edwin Rijo, Gustavo Espino, Ramon Rodriguez Lay, Rafael Estrella, Cristian Gonzalez, Marlin Fernandez, David Soriano, Ingris M Peralta, Steven A Kaplan
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., Department of Urology, Icahn School of Medicine at Mount Sinai, 625 Madison Avenue, 2nd Floor, New York, NY, 10065, USA. .