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Randomized Controlled Trial
. 2015 Feb;193(2):570-8.
doi: 10.1016/j.juro.2014.09.001. Epub 2014 Sep 16.

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

Alexander Bachmann  1 , Andrea Tubaro  2 , Neil Barber  3 , Frank d'Ancona  4 , Gordon Muir  5 , Ulrich Witzsch  6 , Marc-Oliver Grimm  7 , Joan Benejam  8 , Jens-Uwe Stolzenburg  9 , Antony Riddick  10 , Sascha Pahernik  11 , Herman Roelink  12 , Filip Ameye  13 , Christian Saussine  14 , Franck Bruyère  15 , Wolfgang Loidl  16 , Tim Larner  17 , Nirjan-Kumar Gogoi  18 , Richard Hindley  19 , Rolf Muschter  20 , Andrew Thorpe  21 , Nitin Shrotri  22 , Stuart Graham  23 , Moritz Hamann  24 , Kurt Miller  25 , Martin Schostak  26 , Carlos Capitán  27 , Helmut Knispel  28 , J Andrew Thomas  29
Affiliations
Randomized Controlled Trial

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

Alexander Bachmann et al. J Urol. 2015 Feb.

Abstract

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.

Keywords: laser therapy; prostatic hyperplasia; randomized controlled trial; transurethral resection of prostate.

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