Author Interviews, Pharmaceutical Companies, Prostate, Urology / 31.05.2019
Myrbetriq® (mirabegron) Improved BPH Urinary Symptoms in Men Already on Tamsulosin (Flomax)
MedicalResearch.com Interview with:
[caption id="attachment_49467" align="alignleft" width="160"]
Dr. Kaplan[/caption]
Steven A. Kaplan, M.D., FACS
Professor of Urology
Director, The Men's Health Program
Icahn School of Medicine at Mount Sinai
MedicalResearch.com: What is the background for this study?
Response: PLUS is the first large-scale trial conducted in North America and Europe specifically designed to study the effects of mirabegron in controlling residual symptoms of urinary urgency and frequency in men with benign prostatic hyperplasia (BPH) using common agents such as tamsulosin (Flomax).
We explored whether mirabegron (Myrbetriq), an agent approved for the treatment of overactive bladder (OAB), improved patient outcomes when added to tamsulosin. This was a randomized, double-blind, placebo-controlled, multi-center study enrolling 715 male patients 40 years of age and older.
Dr. Kaplan[/caption]
Steven A. Kaplan, M.D., FACS
Professor of Urology
Director, The Men's Health Program
Icahn School of Medicine at Mount Sinai
MedicalResearch.com: What is the background for this study?
Response: PLUS is the first large-scale trial conducted in North America and Europe specifically designed to study the effects of mirabegron in controlling residual symptoms of urinary urgency and frequency in men with benign prostatic hyperplasia (BPH) using common agents such as tamsulosin (Flomax).
We explored whether mirabegron (Myrbetriq), an agent approved for the treatment of overactive bladder (OAB), improved patient outcomes when added to tamsulosin. This was a randomized, double-blind, placebo-controlled, multi-center study enrolling 715 male patients 40 years of age and older.


Dr. Kevin T. McVary[/caption]
Kevin T. McVary, MD, FACS
Chair, Division of Urology
The Pavilion at St. John’s Hospital
Springfield, IL
Chair and Professor of Urology
SIU School of Medicine
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. McVary: Benign Prostatic Hyperplasia (BPH) is a localized enlargement of the prostate gland in aging adult men. It affects approximately 75% of men over the age of 65. This excess growth of tissue compresses and obstructs the urethra, reducing the flow of urine from the bladder and sometimes blocking it entirely. As the symptoms increase, they can greatly impact a man’s quality of life. Both BPH and the existing treatments for it can negatively affect an individual’s sex life.
The Rezūm II IDE pivotal study was a prospective, multicenter, randomized (2:1) controlled trial that enrolled 197 patients across 15 clinical sites in the U.S. The main finding showed that radiofrequency generated convective water vapor thermal therapy provides rapid and sustainable improvement of lower urinary tract symptoms (LUTS) secondary to BPH and urinary flow over a 12-month period without negative effects on erectile and ejaculatory function. These results support the application of convective water vapor energy (WAVE) technology as safe and effective minimally invasive therapeutic alternative for symptomatic BPH. Additionally, no treatment or device related de novo erectile dysfunction occurred after thermal therapy, ejaculatory bother score improved 31% over baseline, and 27% of subjects achieved minimal clinically important differences (MCIDs) in erectile function scores at 1 year, including those with moderate to severe ED.
Dr. Stephen Freedland[/caption]
Stephen J. Freedland, MD
Associate Director, Faculty Development Samuel Oschin Comprehensive Cancer Institute
Co-Director, Cancer Genetics and Prevention Program
Director, Center for Integrated Research in Cancer and Lifestyle
Professor, Surgery
Warschaw Robertson Law Families Chair in Prostate Cancer
Cedars-Sinai, Los Angeles
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Freedland: PSA is a marker of prostate pathology. While often used to screen for prostate cancer, it is not prostate specific and can be elevated due to inflammation or enlarged prostate or other reasons. Whether it predicts the development of urinary symptoms is not clear. Among men with minimal to no urinary symptoms, we found that the higher the PSA, the greater the risk of future development of urinary symptoms.
MedicalResearch.com: What should clinicians and patients take away from your report?
Dr. Freedland: The readers should know that if a man has an elevated PSA and a negative prostate biopsy, the higher the PSA, the greater the risk of future urinary symptoms. These are men who may need closer follow-up.

