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 FDA. Dr. 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.
ABOUT THE AUTHOR
Researcher-physician E. David Crawford, MD, 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.
He is currently a Professor of Urology and Jack A. Vickers Director of Prostate Research at the University of California, San Diego. Dr. Crawford received his medical degree from the University of Cincinnati and his postgraduate training included an internship and residency in urology at the Good Samaritan Hospital in Cincinnati. He subsequently completed a genitourinary cancer fellowship at the University of California Medical Center in Los Angeles.
Dr. Crawford is an internationally recognized expert in benign prostate hypertrophy, urologic cancers, and in particular, prostate cancer. He has conducted research in the treatment of advanced bladder cancer, metastatic adenocarcinoma of the prostate, hormone-refractory prostate cancer, and other areas of urological infections and malignancies. He has authored or coauthored over 810 scientific articles, has published seven textbooks, authored over 60 book chapters, and provided more than 2,200 educational talks for patients and physicians.
In an effort to raise public awareness about prostate health, Crawford in 1989 founded the Prostate Conditions Education Council (PCEC). The non-profit organization is comprised of a consortium of leading physicians, health educators, scientists, and men's health advocates. PCEC's advocacy for free or low-cost prostate screening has affected the lives of millions of American men. He currently chairs the PCEC.
Crawford is an active member of many national and international organizations, including the American Society of Clinical Oncology, the American Urological Association (AUA), and the American Association for the Advancement of Science. Within the AUA, he has been a member of the Committee to Study Urologic Research Funding and the prostate cancer clinical trials subcommittee. Crawford served on the board of governors, the scientific advisory board of the Southwest Oncology Group, and was chairman of the Genitourinary Cancer Committee for 27 years. This group is the largest clinical trials group in the world.
Crawford's involvement in the national prostate cancer arena has been widely recognized. He has received many honors and awards, including the CAP Cure Annual Award for Scientific Presentation in 1999 In 1997, he was presented with a 'Freddie Award" at the AMA International Health and Medical Film Competition for the program, ITV: The Cutting Edge Medical Report (Prostate Cancer: Understanding, Diagnosing, and Defeating), which Crawford hosted with special guest, retired General Norman Schwarzkopf.
Crawford again won a prestigious 'Freddie Award" 5 years ago... He is a member of Best Doctors of America and was named Healthcare Provider of the Year in the Denver Metro area by the Denver Business Journal.
He has been recognized as one of the Best Doctors of America for the past two decades and is recognized as one of the top 20 urologists in the country, for men, by Men’s Health Magazine. In 2018 he received the honor of being named the Distinguished Alumnus of the Year from the University of Cincinnati School of Medicine. In May of 2019, he received the Presidential citation from the American Urological Association recognizing for his “tireless role in genitourinary cancer research that has benefited countless urologic cancer patients.” He accepted the position of Editor in Chief of Grand Rounds in Urology in June of 2019. In 2021, he was the recipient of the Merle Stringer, M.D. annual award for excellence in medicine by the Florida State Medical Association.
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.
Dr. Kaplan graduated from Mount Sinai School of Medicine in 1982. Dr. Kaplan’s postgraduate training included an internship and residency in the Department of Surgery at Mount Sinai Hospital, as well as a residency in urology at the Squier Urologic Clinic at Columbia University.
Dr. Kaplan is a Diplomat of the American Board of Urology and a Fellow of the American College of Surgeons. He is a writer on over 1000 publications, and he is also the co-author of five books and is on the editorial boards of numerous journals, including Urology, the Journal of Urology, and the Urology Times. His landmark study, published in JAMA in 2006, changed the way medications are used in the treatment of men with symptoms related to both benign prostate enlargement and bladder dysfunction.
Dr. Kaplan joined Mount Sinai from Weill Cornell Medical College, where he held the tenured position of E. Darracott Vaughan, Jr., Professor of Urology, and also served as Director of the Iris Cantor Men’s Health Center. While at Weill Cornell Medical College, he was actively engaged in teaching and supervising residents and fellows, and was the Director of the Fellowship Program in Male and Female Voiding Dysfunction. He also held the tenured position of Given Foundation Professor of Urology at Columbia University and was the Vice Chairman and Program Director.
