A Multicenter Randomized Noninferiority Trial Comparing GreenLight-XPS Laser Vaporization of the Prostate and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: Two-yr Outcomes of the GOLIATH Study.
BACKGROUND
The GOLIATH study is a 2-yr trial comparing transurethral resection of prostate (TURP) to photoselective vaporization with the GreenLight XPS Laser System (GL-XPS) for the treatment of benign prostatic obstruction (BPO). Noninferiority of GL-XPS to TURP was demonstrated based on a 6-mo follow-up from the study.


OBJECTIVE
To determine whether treatment effects observed at 6 mo between GL-XPS and TURP was maintained at the 2-yr follow-up.


METHODS
Prospective randomized controlled trial at 29 centers in nine European countries involving 281 patients with BPO.


METHODS
Photoselective vaporization using the 180-W GreenLight GL-XPS or conventional (monopolar or bipolar) TURP.


METHODS
The primary outcome was the International Prostate Symptom Score for which a margin of three was used to evaluate the noninferiority of GL-XPS. Secondary outcomes included Qmax, prostate volume, prostate specific antigen, Overactive Bladder Questionnaire Short Form, International Consultation on Incontinence Questionnaire Short Form, occurrence of surgical retreatment, and freedom from complications.


CONCLUSIONS
One hundred and thirty-six patients were treated using GL-XPS and 133 using TURP. Noninferiority of GL-XPS on International Prostate Symptom Score, Qmax, and freedom from complications was demonstrated at 6-mo and was sustained at 2-yr. The proportion of patients complication-free through 24-mo was 83.6% GL-XPS versus 78.9% TURP. Reductions in prostate volume and prostate specific antigen were similar in both arms and sustained over the course of the trial. Compared with the 1(st) yr of the study, very few adverse events or retreatments were reported in either arm. Treatment differences in the Overactive Bladder Questionnaire Short Form observed at 12-mo were not statistically significant at 24-mo. A limitation was that patients and treating physicians were not blinded to the therapy.


CONCLUSIONS
Twenty-four-mo follow-up data demonstrated that GL-XPS provides a durable surgical option for the treatment of BPO that exhibits efficacy and safety outcomes similar to TURP.


RESULTS
The long-term effectiveness and safety of GLP-XLS was similar to conventional TURP for the treatment of prostate enlargement.
Department of Urology, ABMU LHB, Princess of Wales Hospital, Bridgend, Wales, UK. Electronic address: andyt7264@mac.com.
James A
JA
Thomas
Department of Urology, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy.
Andrea
A
Tubaro
Department of Urology, Frimley Park Hospital, Frimley, Camberley, UK.
Neil
N
Barber
Department of Urology Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.
Frank
F
d'Ancona
Department of Urology, King's College Hospital and King's Health Partners, London, UK.
Gordon
G
Muir
Department of Urology and Pediatric Urology, Krankenhaus Nordwest, Frankfurt, Germany.
Ulrich
U
Witzsch
Department of Urology, University Hospital of Jena, Jena, Germany.
Marc-Oliver
MO
Grimm
Department of Urology, Hospital de Manacor, Manacor, Spain.
Joan
J
Benejam
Department of Urology, Universitätsklinikum Leipzig, Leipzig, Germany.
Jens-Uwe
JU
Stolzenburg
Department of Urology, Lothian University Hospitals Division, Western General Hospital, Edinburgh, UK.
Antony
A
Riddick
Department of Urology, University Hospital of Heidelberg, Heidelberg, Germany.
Sascha
S
Pahernik
Department of Urology, Ziekenhuis Groep Twente, Almelo/Hengelo, The Netherlands.
Herman
H
Roelink
Department of Urology, AZ Maria Middelares Gent, Gent, Belgium.
Filip
F
Ameye
Department of Urology, Nouvel Hopital Civil de Strasbourg, Strasbourg University, Strasbourg, France.
Christian
C
Saussine
Department of Urology, CHRU Bretonneau, Tours, Loire Valley and Université, François Rabelais de Tours, PRES Centre-Val de Loire Université, France.
Franck
F
Bruyère
Department of Urology, Krankenhaus der Barmherzigen Schwestern Linz, Linz, Austria.
Wolfgang
W
Loidl
Department of Urology, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.
Tim
T
Larner
Department of Urology, Mid Yorkshire NHS Trust, Dewsbury and District Hospital, Dewsbury, UK.
Nirjan-Kumar
NK
Gogoi
Department of Urology, Basingstoke and North Hampshire NHS Foundation Trust, Hampshire, UK.
Richard
R
Hindley
Department of Urology, Diakoniekrankenhaus Rotenburg, Rotenburg, Germany.
Rolf
R
Muschter
Department of Urology, Freeman Hospital Newcastle, Newcastle upon Tyne, UK.
Andrew
A
Thorpe
Department of Urology, Kent and Canterbury Hospital, Kent, UK.
Nitin
N
Shrotri
Department of Urology, Whipps Cross University Hospital, London, UK.
Stuart
S
Graham
Department of Urology, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Moritz
M
Hamann
Department of Urology, Charite, Berlin, Germany.
Kurt
K
Miller
Department of Urology, University Hospital Magdeburg, Magdeburg, Germany.
Martin
M
Schostak
Department of Urology, Hospital Universitario Fundacion Alcorcon, Madrid, Spain.
Carlos
C
Capitán
Department of Urology, Uro-Forschungs GmbH im St. Hedwig Krankenhaus, Berlin, Germany.
Helmut
H
Knispel
Department of Urology Basel, University Hospital Basel, University Basel, Basel, Switzerland. Electronic address: alexander.bachmann@usb.ch.
Alexander
A
Bachmann
D005500:Follow-Up Studies; D006801:Humans; D053844:Lasers, Solid-State / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D009929:Organ Size; D017060:Patient Satisfaction; D011446:Prospective Studies; D011467:Prostate / Q000473:pathology*; D017430:Prostate-Specific Antigen / Q000097:blood; D011470:Prostatic Hyperplasia / Q000097:blood / Q000473:pathology / Q000601:surgery*; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D020728:Transurethral Resection of Prostate / Q000009:adverse effects / Q000379:methods*; D016896:Treatment Outcome; D014549:Urinary Incontinence / Q000209:etiology
D017430:Prostate-Specific Antigen
Benign prostate obstruction; Benign prostatic hyperplasia; GL-XPS; International Prostate Symptom Scores; Lower urinary tract symptoms; Photoselective vaporization of the prostate Quality of Life; Transurethral resection of prostate