MedicalResearch.com Interview with:
Kevin T. McVary, MD, FACS
Chair, Division of Urology
The Pavilion at St. John’s Hospital
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.
MedicalResearch.com: What should readers take away from your report?
Dr. McVary: This data demonstrates the Rezūm system not only provides an effective treatment option for men suffering from BPH, but does so while preserving sexual function and improving their quality of life.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. McVary: Direct comparisons of this treatment with existing and more established therapies, such as TURP or laser procedures, need to be performed. Additionally, durability of treatment impact needs to be carefully evaluated and such plans are already underway.
MedicalResearch.com: Is there anything else you would like to add?
Dr. McVary: WAVE therapy is an effective non-pharmaceutical treatment option and can be performed in a doctor’s office. The procedure takes approximately five minutes to perform and patients can resume normal activities soon after the procedure. Preliminary effects from Rezūm can be seen within two weeks, with stable results at three months.
2016 AUA abstract:
PD21-04 TREATMENT OF LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC HYPERPLASIA WITH CONVECTIVE WATER VAPOR ENERGY ABLATION: PRESERVED ERECTILE AND EJACULATORY FUNCTION
McVary, Kevin Gange, StevenGittelman, MarcGoldberg, KennethPatel, KalpeshShore, NealLevin, RichardRousseau, MichaelBeahrs, J. RandolfKaminetsky, JedCowan, BarrettCantrill, ChristopherMynderse, LanceUlchaker, JamesLarson, ThayneDixon, ChristopherRoehrborn, Claus et al.
The Journal of Urology , Volume 195 , Issue 4 , e457 – e458
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