E. David Crawford, MD, and Steven A. Kaplan, MD, presented “Optilume® BPH Catheter System Data from the PINNACLE Trial Published in the September 2023 Journal of Urology” for the Grand Rounds in Urology audience in October 2023.

How to cite: Crawford, E. David. MD, and Kaplan, Steven A., MD. “Optilume® BPH Catheter System Data from the PINNACLE Trial Published in the September 2023 Journal of Urology.” October 2023. Accessed Jul 2024. https://grandroundsinurology.com/optilume-bph-catheter-system-data-from-the-pinnacle-trial-published-in-the-september-2023-journal-of-urology/

Optilume® BPH Catheter System Data from the PINNACLE Trial Published in the September 2023 Journal of Urology

Steven A. Kaplan, MD, joins E. David Crawford, MD, Editor-in-Chief of Grand Rounds in Urology, to discuss the results of the PINNACLE trial published in the September 2023 issue of the Journal of Urology. The PINNACLE trial was a Phase 3 study examining the effectiveness of treating benign prostate hyperplasia (BPH) with the Optilume® BPH Catheter System.

The Optilume® BPH Catheter System is a novel drug/device combination minimally invasive surgical therapy for the treatment of lower urinary tract symptoms secondary to BPH, and it has been recently approved by the FDADr. Kaplan explains how the mechanical dilation with Optilume® BPH achieves an anterior commissurotomy separating the lateral lobes of the prostate, while delivery of paclitaxel is intended to maintain luminal patency during healing.

Over the course of the discussion, Drs. Kaplan and Crawford examine:

  • The history of devices used to treat BPH.
  • The design of the Optilume® BPH Catheter System and its effects on flow and proliferative rates.
  • The design of the PINNACLE trial.
  • The immediate and long-term results for patients treated with Optilume® BPH versus those of patients treated with the sham.
  • What the results may mean for the future of BPH treatment in office and ambulatory settings.

For more informational content on the latest developments on men’s health topics like BPH, please visit our Men’s Health Next-Generation Learning Center.


Researcher-physician E. David Crawford, MD, Jack A. Vickers Director of Prostate Research and Professor of Urology at the University of California, San Diego, has devoted his career in medicine to educating the public about men's health issues and finding effective techniques and procedures to address prostate cancer, the most common malignancy affecting men in the United States.

Dr. Steven A. Kaplan is the Director of the Men’s Wellness Program at Mount Sinai Health System and a Professor of Urology at the Icahn School of Medicine at Mount Sinai. He is an internationally renowned leader in the study of benign diseases of the prostate, the association of metabolic factors with voiding dysfunction, and female urology.