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JU INSIGHT The PINNACLE Study: Optilume BPH Catheter System for Lower Urinary Tract Symptoms

By: Steven A. Kaplan, MD, Icahn School of Medicine at Mount Sinai, New York, New York; Jared Moss, MD, Oschner LSU Health, Shreveport, Louisiana; Sheldon Freedman, MD, Sheldon Freedman Urology, Las Vegas, Nevada; Karl Coutinho, MD, New Jersey Urology LLC, Millburn; Ning Wu, MD, Comprehensive Urologic Care, Lake Barrington, Illinois; Mitchell Efros, MD, Accumed Research Associates, Garden City, New York; Dean Elterman, MD, University of Toronto, Ontario, Canada; Richard D’Anna, MD, Arkansas Urology, Little Rock; Osvaldo Padron, MD, Florida Urology Partners, Tampa; Kaiser J. Robertson, MD, Chesapeake Urology, Hanover, Maryland; Samuel Lawindy, MD, Advanced Urology Institute, Daytona Beach, Florida; Sandeep Mistry, MD, North Austin Urology, Texas; Neal Shore, MD, Carolina Urologic Research Center, Myrtle Beach, South Carolina; Jeffrey Spier, MD, Rio Grande Urology, El Paso, Texas; Jed Kaminetsky, MD, Manhattan Medical Research Center, New York; Brian Mazzarella, MD, Urology Austin, Texas; David Cahn, MD, Colorado Clinical Research, Lakewood; Mark Jalkut, MD, Associated Urologists of North Carolina, Raleigh; Alexis Te, MD, Weill Medical College of Cornell University, New York, New York | Posted on: 19 Sep 2023

Kaplan SA, Moss J, Freedman S, et al. The PINNACLE study: a double-blind, randomized, sham-controlled study evaluating the Optilume BPH catheter system for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol. 2023;210(3):500-509.

Study Need and Importance

The percentage of men who suffer annually from urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) remains high (70% of men >70 years); however, less than 3% of drug therapy or watchful waiting patients move to surgical intervention, likely due to unwanted side effects and diminished sexual function. Minimally invasive BPH therapies have done well minimizing these effects, but they have failed to achieve their goal of replacing maximum urinary flow rates (Qmax) associated with transurethral prostatectomy—until now.

What We Found

We randomized 148 men (100 active, 48 sham) at 18 centers in North America. Subjects receiving Optilume BPH saw a mean±SD reduction in International Prostate Symptom Score of 11.5±7.8 points at 1 year, as compared to a reduction of 8.0±8.3 points at 3 months in the sham arm. Qmax improved dramatically after treatment with Optilume BPH, with an improvement of +10.3 mL/s from baseline to 1 year (+125%; see Figure). Treatment with Optilume BPH provides immediate and sustained improvements in obstructive symptoms and flow rate while preserving erectile and ejaculatory function. Treatment is well tolerated and can be done in an office or ambulatory setting.

Figure. Peak urinary flow rate (Qmax) after treatment with Optilume BPH (as observed).


Eligibility criteria for this study limited enrollment to those men with prostates below 80 g and with moderate or severe symptoms and restricted flow; results may not be generalizable to all men with lower urinary tract symptoms secondary to BPH.

Interpretation for Patient Care

Treatment of lower urinary tract symptoms secondary to obstructive BPH with Optilume BPH results in significant and clinically meaningful improvements immediately postprocedure, which are sustained through 1 year of follow-up. The improvement seen for Qmax and postvoid residual through 1 year represents the largest seen for this product class. This minimally invasive treatment represents an attractive option to patients looking to maintain sexual function while achieving durable symptom relief and improved flow.