MedicalResearch.com Interview with:
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.
MedicalResearch.com: What are the main findings?
Response: Overall, the results demonstrated the addition of mirabegron to tamsulosin significantly improved symptoms of urinary urgency and frequency. Specifically, patients treated with tamsulosin and mirabegron demonstrated a statistically significant reduction in average number of micturitions (episodes of urination) per day compared to patients treated with tamsulosin and placebo. The group treated with tamsulosin and mirabegron also showed an increase in mean volume voided (MVV) per micturition, a reduction in urgency episodes per day and improvements in total urgency and frequency score compared to the group treated with tamsulosin and placebo.
MedicalResearch.com: What should readers take away from your report?
Response: Lower urinary tract symptoms are highly prevalent in men over the age of 40, yet the treatment of urinary conditions in males can be challenging for clinicians, so this was a particularly interesting and important area of study. The findings highlight that men often will need the right combination of drug therapies to enhance the benefit and improve symptoms more effectively. These data add an insightful new dimension to our understanding of urologic conditions impacting men.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: The PLUS study opens the pathways for further research that can help determine who are the right patients to place on combination therapy from the outset of treatment, and how to better identify which therapies may work most effectively for individual patients.
Disclosures: I served as the primary investigator for the PLUS study
AUA abstract May 5 2019
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