Clinical Data Highlights:
At 30 months, the adjusted STFS was higher in the HIFU arm (90%) compared with RP arm (86%)
The propensity score-adjusted result is similar to the univariate result (HR=0.71 [95%CI, 0.52-0.97], p=0.008). After adjustment on different variables (Age, BMI, ASA score, Grade Group, prostate volume, PSA): the risk of salvage treatment is lower in the HIFU arm compared to RP. This result remains true when analyzing the subgroup with intermediate risk (HR=0.66 [95%CI, 0.50-0.86], p=0.001).
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International Continence Society (ICS) score, a measure of stress urinary incontinence was significantly less deteriorated for HIFU (29%) vs, RP (44%) (RR=0.66 [95%CI, 0.59-0.74], p<0.001) for all ages combined.
International Index of Erectile Function-5 (IIEF-5), a well validated measurement of erectile function, decreased significantly less after HIFU than after RP with a drop in difference in medians from -9 (-10;-7.7) to -3.0 (-3.9; -2.1) between both groups, for all ages included.
Post-procedural benefits of HIFU on both erectile function and urinary continence were demonstrated despite patients in the HIFU-treated group being an average of 9.6 years older (median age was 74.7 years for HIFU vs 65.1 years for RP, p<0.001)
About European Urology
European Urology is the official journal of the European Association of Urology (EAU). European Urology publishes peer-reviewed original articles and topical reviews on a wide range of urological problems. Topics such as oncology, impotence, infertility, pediatrics, lithiasis and endourology, as well as recent advances in techniques, instrumentation, surgery and pediatric urology provide readers with a complete guide to international developments in urology. Published monthly, European Urology is an important journal for all clinicians and researchers in this field. The 2023 Impact Factor of European Urology is 25.3, the highest impact factor of all urology-focused scientific journals.
About EDAP TMS SA
A recognized leader in the robotic energy-based therapies, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for various conditions using ultrasound technology. By combining the latest technologies in imaging, robotics and precise non-invasive energy delivery, EDAP TMS introduced the Focal One® in Europe and in the U.S. as the leading prostate focal therapy controlled by urologists with the potential to expand to multiple indications beyond prostate cancer. For more information on the Company, please visit http://www.edap-tms.com, us.hifu-prostate.com and www.focalone.com.
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