title: 180-W XPS GreenLight laser vaporisation versus transurethral resection of the prostate for the treatment of benign prostatic obstruction: 6-month safety and efficacy results of a European Multicentre Randomised Trial--the GOLIATH study.
abstract: BACKGROUND
  The comparative outcome with GreenLight (GL) photoselective vaporisation of the prostate and transurethral resection of the prostate (TURP) in men with lower urinary tract symptoms due to benign prostatic obstruction (BPO) has been questioned.
  
  
  OBJECTIVE
  The primary objective of the GOLIATH study was to evaluate the noninferiority of 180-W GL XPS (XPS) to TURP for International Prostate Symptom Score (IPSS) and maximum flow rate (Qmax) at 6 mo and the proportion of patients who were complication free.
  
  
  METHODS
  Prospective randomised controlled trial at 29 centres in 9 European countries involving 281 patients with BPO.
  
  
  METHODS
  180-W GL XPS system or TURP.
  
  
  METHODS
  Measurements used were IPSS, Qmax, prostate volume (PV), postvoid residual (PVR) and complications, perioperative parameters, and reintervention rates. Noninferiority was evaluated using one-sided tests at the 2.5% level of significance. The statistical significance of other comparisons was assessed at the (two-sided) 5% level.
  
  
  CONCLUSIONS
  The study demonstrated the noninferiority of XPS to TURP for IPSS, Qmax, and complication-free proportion. PV and PVR were comparable between groups. Time until stable health status, length of catheterisation, and length of hospital stay were superior with XPS (p<0.001). Early reintervention rate within 30 d was three times higher after TURP (p=0.025); however, the overall postoperative reintervention rates were not significantly different between treatment arms. A limitation was the short follow-up.
  
  
  CONCLUSIONS
  XPS was shown to be noninferior (comparable) to TURP in terms of IPSS, Qmax, and proportion of patients free of complications. XPS results in a lower rate of early reinterventions but has a similar rate after 6 mo.
  
  
  BACKGROUND
  ClinicalTrials.gov, identifier NCT01218672.
authors: Department of Urology Basel, University Hospital Basel, University Basel, Basel, Switzerland. Electronic address: Alexander.Bachmann@usb.ch.
authors: Alexander
authors: A
authors: Bachmann
authors: Department of Urology, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy.
authors: Andrea
authors: A
authors: Tubaro
authors: Department of Urology, Frimley Park Hospital, Frimley, Camberley, UK.
authors: Neil
authors: N
authors: Barber
authors: Department of Urology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.
authors: Frank
authors: F
authors: d'Ancona
authors: Department of Urology, King's College Hospital and King's Health Partners, London, UK.
authors: Gordon
authors: G
authors: Muir
authors: Department of Urology and Paediatric Urology, Krankenhaus Nordwest, Frankfurt, Germany.
authors: Ulrich
authors: U
authors: Witzsch
authors: Department of Urology, University Hospital of Jena, Jena, Germany.
authors: Marc-Oliver
authors: MO
authors: Grimm
authors: Department of Urology, Hospital de Manacor, Manacor, Spain.
authors: Joan
authors: J
authors: Benejam
authors: Department of Urology, Universitätsklinikum Leipzig, Leipzig, Germany.
authors: Jens-Uwe
authors: JU
authors: Stolzenburg
authors: Department of Urology, Lothian University Hospitals Division, Western General Hospital, Edinburgh, UK.
authors: Antony
authors: A
authors: Riddick
authors: Department of Urology, University Hospital of Heidelberg, Heidelberg, Germany.
authors: Sascha
authors: S
authors: Pahernik
authors: Department of Urology, Ziekenhuis Groep Twente, Almelo/Hengelo, The Netherlands.
authors: Herman
authors: H
authors: Roelink
authors: Department of Urology, AZ Maria Middelares Gent, Gent, Belgium.
authors: Filip
authors: F
authors: Ameye
authors: Department of Urology, Nouvel Hôpital Civil de Strasbourg, Strasbourg University, Strasbourg, France.
authors: Christian
authors: C
authors: Saussine
authors: Department of Urology, CHRU Bretonneau, Tours, Loire Valley, and Université François Rabelais de Tours, PRES Centre-Val de Loire Université, Tours, France.
authors: Franck
authors: F
authors: Bruyère
authors: Department of Urology, Krankenhaus der Barmherzigen Schwestern Linz, Linz, Austria.
authors: Wolfgang
authors: W
authors: Loidl
authors: Department of Urology, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.
authors: Tim
authors: T
authors: Larner
authors: Department of Urology, Mid Yorkshire NHS Trust, Dewsbury & District Hospital, Dewsbury, UK.
authors: Nirjan-Kumar
authors: NK
authors: Gogoi
authors: Department of Urology, Basingstoke and North Hampshire NHS Foundation Trust, Hampshire, UK.
authors: Richard
authors: R
authors: Hindley
authors: Department of Urology, Diakoniekrankenhaus Rotenburg, Rotenburg, Germany.
authors: Rolf
authors: R
authors: Muschter
authors: Department of Urology, Freeman Hospital Newcastle, Newcastle upon Tyne, UK.
authors: Andrew
authors: A
authors: Thorpe
authors: Department of Urology, Kent and Canterbury Hospital, Kent, UK.
authors: Nitin
authors: N
authors: Shrotri
authors: Department of Urology, Whipps Cross University Hospital, London, UK.
authors: Stuart
authors: S
authors: Graham
authors: Department of Urology, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany.
authors: Moritz
authors: M
authors: Hamann
authors: Department of Urology, Charité, Berlin, Germany.
authors: Kurt
authors: K
authors: Miller
authors: Department of Urology, University Hospital Magdeburg, Magdeburg, Germany.
authors: Martin
authors: M
authors: Schostak
authors: Department of Urology, Hospital Universitario Fundación Alcorcón, Madrid, Spain.
authors: Carlos
authors: C
authors: Capitán
authors: Department of Urology, Uro-Forschungs GmbH im St. Hedwig Krankenhaus, Berlin, Germany.
authors: Helmut
authors: H
authors: Knispel
authors: Department of Urology, ABMU LHB, Princess of Wales Hospital, Bridgend, Wales, UK.
authors: J Andrew
authors: JA
authors: Thomas
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005060:Europe; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000209:etiology; D006801:Humans; D057194:Intention to Treat Analysis; D053685:Laser Therapy / Q000009:adverse effects; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D009929:Organ Size; D011446:Prospective Studies; D011467:Prostate / Q000473:pathology*; D017430:Prostate-Specific Antigen / Q000097:blood; D011468:Prostatectomy / Q000009:adverse effects; D011470:Prostatic Hyperplasia / Q000097:blood / Q000150:complications* / Q000601:surgery*; D053448:Prostatism / Q000209:etiology* / Q000503:physiopathology; D012720:Severity of Illness Index; D013997:Time Factors; D014546:Urinary Catheterization; D014549:Urinary Incontinence / Q000209:etiology; D016055:Urinary Retention / Q000209:etiology; D014563:Urodynamics
chemical_list: D017430:Prostate-Specific Antigen
keywords: Adverse events; Benign prostatic obstruction (BPO); Clavien-Dindo classification; Efficacy; GreenLight XPS 180-W laser; Photoselective vaporisation of the prostate (PVP); Safety; TURP; Transurethral surgery