Stockholm, Sweden—Photoselective vaporization of the prostate (PVP) is non-inferior to transurethral resection of the prostate (TURP) in men with benign prostatic obstruction (BPO), researchers reported at the European Association of Urology annual congress in Stockholm, Sweden.
Study authors presented 1-year follow-up data of the Goliath Study, a large open-label, prospective, European, multicenter, randomized controlled trial that compared GreenLight XPS (American Medical Systems, Minnetonka, MN) PVP and TURP in men with BPO over 6 months. The study’s primary targets were International Prostate Symptom Score (IPSS), maximum flow rate (Qmax), and complication-free rate, with a follow-up time of 2 years.
“An investigation comparing GL-XPS and TURP that included a lengthy follow-up period was vital to prove the safety and efficacy of the laser system and dispel any doubts concerning increased adverse events following XPS,” principal investigator and co-author Alexander Bachmann, MD, told Urology Times.
“We showed at 6 months and again at 1 year after surgery that side effects and complications of XPS laser were non-inferior—meaning comparable—to TURP. In fact, the questionnaires revealed that the re-intervention rate was higher after TURP, as was recovery, again substantiating that side effects are not higher with XPS,” said Dr. Bachmann, chair of urology and head of the Bladder-Kidney-Prostate Tumor Center at the University of Basel in Basel, Switzerland.
The Goliath Study included 291 patients who were enrolled between April 2011 and September 2011 at 29 sites in nine European countries. A total of 281 were randomized and 269 received treatment. Non-inferiority was evaluated using one-sided tests at the 2.5% level of significance. An IPSS margin of 3 was deemed necessary to demonstrate non-inferiority. The trial was also powered to compare Qmax and the complication-free rate at 6 months, evaluated at the two-sided (5%) level.
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