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J Urol. 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.

Author information

1
Department of Urology Basel, University Hospital Basel, University Basel, Basel, Switzerland. Electronic address: alexander.bachmann@usb.ch.
2
Department of Urology, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy.
3
Department of Urology, Frimley Park Hospital, Frimley, Camberley.
4
Department of Urology, Radboud University, Nijmegen Medical Centre, Nijmegen, The Netherlands.
5
Department of Urology, King's College Hospital and King's Health Partners, London.
6
Department of Urology and Pediatric Urology, Krankenhaus Nordwest, Frankfurt, Germany.
7
Department of Urology, University Hospital of Jena, Jena, Germany.
8
Department of Urology, Hospital de Manacor, Manacor, Spain.
9
Department of Urology, Universitätsklinikum Leipzig, Leipzig, Germany.
10
Department of Urology, Lothian University Hospitals Division, Western General Hospital, Edinburgh.
11
Department of Urology, University Hospital of Heidelberg, Heidelberg, Germany.
12
Department of Urology, Ziekenhuis Groep Twente, Almelo/Hengelo, The Netherlands.
13
Department of Urology, AZ Maria Middelares Gent, Gent, Belgium.
14
Department of Urology, Nouvel Hopital Civil de Strasbourg, Strasbourg University, Strasbourg, France.
15
Department of Urology, CHRU Bretonneau, Tours, Loire Valley and Université François Rabelais de Tours, PRES Centre- Val de Loire Université, Val de Loire, France.
16
Department of Urology, Krankenhaus der Barmherzigen Schwestern Linz, Linz, Austria.
17
Department of Urology, Brighton and Sussex University Hospitals NHS Trust, Brighton.
18
Department of Urology, Mid Yorkshire NHS Trust, Dewsbury & District Hospital, Dewsbury.
19
Department of Urology, Basingstoke and North Hampshire NHS Foundation Trust, Hampshire.
20
Department of Urology, Diakoniekrankenhaus Rotenburg, Rotenburg, Germany.
21
Department of Urology, Freeman Hospital Newcastle, Newcastle upon Tyne.
22
Department of Urology, Kent and Canterbury Hospital, Kent.
23
Department of Urology, Whipps Cross University Hospital, London.
24
Department of Urology, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany.
25
Department of Urology, Charite, Germany.
26
Department of Urology, University Hospital Magdeburg, Magdeburg, Germany.
27
Department of Urology, Hospital Universitario Fundacion Alcorcon, Madrid, Spain.
28
Department of Urology, Uro-Forschungs GmbH im St. Hedwig Krankenhaus, Berlin, Germany.
29
Department of Urology, ABMU LHB, Princess of Wales Hospital, Bridgend, Wales. Electronic address: andrew.thomas@wales.nhs.uk.

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

PMID:
25219699
DOI:
10.1016/j.juro.2014.09.001
[Indexed for MEDLINE]

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