A European Multicenter Randomized Noninferiority Trial Comparing 180 W GreenLight XPS Laser Vaporization and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: 12-Month Results of the GOLIATH Study

作者：Bachmann Alexander^*; Tubaro Andrea; Barber Neil; d'Ancona Frank; Muir Gordon; Witzsch Ulrich; Grimm Marc Oliver; Benejam Joan; Stolzenburg Jens Uwe; Riddick Antony; Pahernik Sascha; Roelink Herman; Ameye Filip; Saussine Christian; Bruyere Franck; Loidl Wolfgang; Larner Tim; Gogoi Nirjan Kumar; Hindley Richard; Muschter Rolf; Thorpe Andrew; Shrotri Nitin; Graham Stuart; Hamann Moritz; Miller Kurt; Schostak Martin; Capitan Carlos; Knispel Helmut; Thomas J Andrew

来源：Journal of Urology, 2015, 193(2): 570-578.

DOI：10.1016/j.juro.2014.09.001

• prostatic hyperplasia
• transurethral resection of prostate
• randomized controlled trial
• laser therapy

Purpose: We present the 1-year results of the GOLIATH prospective randomized controlled trial comparing transurethral resection of the prostate to GreenLight XPS for the treatment of men with nonneurogenic lower urinary tract symptoms due to prostate enlargement. The updated results at 1 year show that transurethral resection of the prostate and GreenLight XPS remain equivalent, and confirm the therapeutic durability of both procedures. We also report 1-year followup data from several functional questionnaires (OABq-SF, ICIQ-SF and IIEF-5) and objective assessments.
Materials and Methods: A total of 291 patients were enrolled at 29 sites in 9 European countries. Patients were randomized 1: 1 to undergo GreenLight XPS or transurethral resection of the prostate. The trial was designed to evaluate the hypothesis that GreenLight XPS is noninferior to transurethral resection of the prostate on the International Prostate Symptom Score at 6 months. Several objective parameters were assessed, including maximum urinary flow rate, post-void residual urine volume, prostate volume and prostate specific antigen, in addition to functional questionnaires and adverse events at each followup.
Results: Of the 291 enrolled patients 281 were randomized and 269 received treatment. Noninferiority of GreenLight XPS was maintained at 12 months. Maximum urinary flow rate, post-void residual urine volume, prostate volume and prostate specific antigen were not statistically different between the treatment arms at 12 months. The complication-free rate at 1 year was 84.6% after GreenLight XPS vs 80.5% after transurethral resection of the prostate. At 12 months 4 patients treated with GreenLight XPS and 4 who underwent transurethral resection of the prostate had unresolved urinary incontinence.
Conclusions: Followup at 1 year demonstrated that photoselective vaporization of the prostate produced efficacy outcomes similar to those of transurethral resection of the prostate. The complication-free rates and overall reintervention rates were comparable between the treatment groups.

• 出版日期2015-2