Urotronic, Inc., a Minnesota-based medical device company pioneering the application of its drug-coated balloon technology for use in interventional urology, today announced the publication of positive data from its PINNACLE clinical trial evaluating the Optilume® BPH Catheter System’s safety, effectiveness and durability in treating lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). Twelve-month data from the PINNACLE clinical trial was published in the September 2023 edition of the Journal of Urology and featured on the cover.
“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,” was authored by Dr. Steven A. Kaplan, professor of urology at the Icahn School of Medicine at Mount Sinai in New York and the principal investigator of the PINNACLE study.
“Minimally invasive surgical therapies (MISTs) for BPH have done well minimizing negative effects seen with more invasive treatments such as transurethral resection of the prostate (TURP), but they have failed to achieve their goal of replacing flow rates (Qmax) – until now,” said Dr. Kaplan. “The improvement seen for Qmax and post-void residual volume (PVR) through one year represents the largest seen in BPH MIST trials to date. Optilume BPH is an attractive option for physicians and patients looking to maintain sexual function while achieving durable symptom relief and improved flow.”
Recently approved by the U.S. Food and Drug Administration, Optilume BPH is a unique MIST that combines mechanical dilation using a proprietary double-lobe balloon with concurrent localized delivery of paclitaxel for the treatment of 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.
Published PINNACLE outcomes include:
- Subjects receiving Optilume BPH saw a reduction in International Prostate Symptom Score (IPSS) 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.
- The highest Qmax at 12 months reported in randomized MIST trials for BPH. Qmax improved dramatically after treatment with Optilume BPH, with an improvement of +10.3 mL/s from baseline to 1 year (+125%).
- Durability of symptom and flow rate improvement was shown through one year follow-up.
- Erectile and ejaculatory function scores were not significantly changed from baseline through follow-up as measured by validated questionnaires.
“Optilume BPH is the first combination drug and device therapy offering the highest clinically reported flow rates of any minimal invasive therapy with immediate and sustained improvement in IPSS symptom scores,” said David Perry, Urotronic president and CEO. “The recent FDA approval and published positive data will quickly establish Optilume BPH as a new standard for physicians and men looking for rapid and sustained results in treating LUTS caused by BPH.”
The PINNACLE trial is a prospective, randomized, double-blind, sham controlled study evaluating the Optilume BPH System with 148 patients randomized in a 2:1 fashion at 18 centers in the U.S. and Canada. Subjects and evaluating personnel were blinded to the treatment received through 12 months.