title: 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.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Department of Urology Basel, University Hospital Basel, University Basel, Basel, Switzerland. Electronic address: alexander.bachmann@usb.ch.
authors.forename: Alexander
authors.initials: A
authors.lastname: Bachmann
authors.affiliation: Department of Urology, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Tubaro
authors.affiliation: Department of Urology, Frimley Park Hospital, Frimley, Camberley.
authors.forename: Neil
authors.initials: N
authors.lastname: Barber
authors.affiliation: Department of Urology, Radboud University, Nijmegen Medical Centre, Nijmegen, The Netherlands.
authors.forename: Frank
authors.initials: F
authors.lastname: d'Ancona
authors.affiliation: Department of Urology, King's College Hospital and King's Health Partners, London.
authors.forename: Gordon
authors.initials: G
authors.lastname: Muir
authors.affiliation: Department of Urology and Pediatric Urology, Krankenhaus Nordwest, Frankfurt, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Witzsch
authors.affiliation: Department of Urology, University Hospital of Jena, Jena, Germany.
authors.forename: Marc-Oliver
authors.initials: MO
authors.lastname: Grimm
authors.affiliation: Department of Urology, Hospital de Manacor, Manacor, Spain.
authors.forename: Joan
authors.initials: J
authors.lastname: Benejam
authors.affiliation: Department of Urology, Universitätsklinikum Leipzig, Leipzig, Germany.
authors.forename: Jens-Uwe
authors.initials: JU
authors.lastname: Stolzenburg
authors.affiliation: Department of Urology, Lothian University Hospitals Division, Western General Hospital, Edinburgh.
authors.forename: Antony
authors.initials: A
authors.lastname: Riddick
authors.affiliation: Department of Urology, University Hospital of Heidelberg, Heidelberg, Germany.
authors.forename: Sascha
authors.initials: S
authors.lastname: Pahernik
authors.affiliation: Department of Urology, Ziekenhuis Groep Twente, Almelo/Hengelo, The Netherlands.
authors.forename: Herman
authors.initials: H
authors.lastname: Roelink
authors.affiliation: Department of Urology, AZ Maria Middelares Gent, Gent, Belgium.
authors.forename: Filip
authors.initials: F
authors.lastname: Ameye
authors.affiliation: Department of Urology, Nouvel Hopital Civil de Strasbourg, Strasbourg University, Strasbourg, France.
authors.forename: Christian
authors.initials: C
authors.lastname: Saussine
authors.affiliation: Department of Urology, CHRU Bretonneau, Tours, Loire Valley and Université François Rabelais de Tours, PRES Centre- Val de Loire Université, Val de Loire, France.
authors.forename: Franck
authors.initials: F
authors.lastname: Bruyère
authors.affiliation: Department of Urology, Krankenhaus der Barmherzigen Schwestern Linz, Linz, Austria.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Loidl
authors.affiliation: Department of Urology, Brighton and Sussex University Hospitals NHS Trust, Brighton.
authors.forename: Tim
authors.initials: T
authors.lastname: Larner
authors.affiliation: Department of Urology, Mid Yorkshire NHS Trust, Dewsbury & District Hospital, Dewsbury.
authors.forename: Nirjan-Kumar
authors.initials: NK
authors.lastname: Gogoi
authors.affiliation: Department of Urology, Basingstoke and North Hampshire NHS Foundation Trust, Hampshire.
authors.forename: Richard
authors.initials: R
authors.lastname: Hindley
authors.affiliation: Department of Urology, Diakoniekrankenhaus Rotenburg, Rotenburg, Germany.
authors.forename: Rolf
authors.initials: R
authors.lastname: Muschter
authors.affiliation: Department of Urology, Freeman Hospital Newcastle, Newcastle upon Tyne.
authors.forename: Andrew
authors.initials: A
authors.lastname: Thorpe
authors.affiliation: Department of Urology, Kent and Canterbury Hospital, Kent.
authors.forename: Nitin
authors.initials: N
authors.lastname: Shrotri
authors.affiliation: Department of Urology, Whipps Cross University Hospital, London.
authors.forename: Stuart
authors.initials: S
authors.lastname: Graham
authors.affiliation: Department of Urology, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany.
authors.forename: Moritz
authors.initials: M
authors.lastname: Hamann
authors.affiliation: Department of Urology, Charite, Germany.
authors.forename: Kurt
authors.initials: K
authors.lastname: Miller
authors.affiliation: Department of Urology, University Hospital Magdeburg, Magdeburg, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Schostak
authors.affiliation: Department of Urology, Hospital Universitario Fundacion Alcorcon, Madrid, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Capitán
authors.affiliation: Department of Urology, Uro-Forschungs GmbH im St. Hedwig Krankenhaus, Berlin, Germany.
authors.forename: Helmut
authors.initials: H
authors.lastname: Knispel
authors.affiliation: Department of Urology, ABMU LHB, Princess of Wales Hospital, Bridgend, Wales. Electronic address: andrew.thomas@wales.nhs.uk.
authors.forename: J Andrew
authors.initials: JA
authors.lastname: Thomas
mesh_terms: D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000209:etiology / Q000601:surgery*; D008297:Male; D011446:Prospective Studies; D011470:Prostatic Hyperplasia / Q000150:complications / Q000601:surgery*; D013997:Time Factors; D020728:Transurethral Resection of Prostate / Q000379:methods*; D016896:Treatment Outcome; D001748:Urinary Bladder Neck Obstruction / Q000209:etiology / Q000601:surgery*
keywords: laser therapy; prostatic hyperplasia; randomized controlled trial; transurethral resection of prostate