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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.
Eur Urol. 2014 May; 65(5):931-42.EU

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.

DESIGN, SETTING, AND PARTICIPANTS

Prospective randomised controlled trial at 29 centres in 9 European countries involving 281 patients with BPO.

INTERVENTION

180-W GL XPS system or TURP.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

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.

RESULTS AND LIMITATIONS

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.

TRIAL REGISTRATION

ClinicalTrials.gov, identifier NCT01218672.

Authors+Show Affiliations

Department of Urology Basel, University Hospital Basel, University Basel, Basel, Switzerland. Electronic address: Alexander.Bachmann@usb.ch.Department of Urology, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy.Department of Urology, Frimley Park Hospital, Frimley, Camberley, UK.Department of Urology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.Department of Urology, King's College Hospital and King's Health Partners, London, UK.Department of Urology and Paediatric Urology, Krankenhaus Nordwest, Frankfurt, Germany.Department of Urology, University Hospital of Jena, Jena, Germany.Department of Urology, Hospital de Manacor, Manacor, Spain.Department of Urology, Universitätsklinikum Leipzig, Leipzig, Germany.Department of Urology, Lothian University Hospitals Division, Western General Hospital, Edinburgh, UK.Department of Urology, University Hospital of Heidelberg, Heidelberg, Germany.Department of Urology, Ziekenhuis Groep Twente, Almelo/Hengelo, The Netherlands.Department of Urology, AZ Maria Middelares Gent, Gent, Belgium.Department of Urology, Nouvel Hôpital Civil de Strasbourg, Strasbourg University, Strasbourg, France.Department of Urology, CHRU Bretonneau, Tours, Loire Valley, and Université François Rabelais de Tours, PRES Centre-Val de Loire Université, Tours, France.Department of Urology, Krankenhaus der Barmherzigen Schwestern Linz, Linz, Austria.Department of Urology, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.Department of Urology, Mid Yorkshire NHS Trust, Dewsbury & District Hospital, Dewsbury, UK.Department of Urology, Basingstoke and North Hampshire NHS Foundation Trust, Hampshire, UK.Department of Urology, Diakoniekrankenhaus Rotenburg, Rotenburg, Germany.Department of Urology, Freeman Hospital Newcastle, Newcastle upon Tyne, UK.Department of Urology, Kent and Canterbury Hospital, Kent, UK.Department of Urology, Whipps Cross University Hospital, London, UK.Department of Urology, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany.Department of Urology, Charité, Berlin, Germany.Department of Urology, University Hospital Magdeburg, Magdeburg, Germany.Department of Urology, Hospital Universitario Fundación Alcorcón, Madrid, Spain.Department of Urology, Uro-Forschungs GmbH im St. Hedwig Krankenhaus, Berlin, Germany.Department of Urology, ABMU LHB, Princess of Wales Hospital, Bridgend, Wales, UK.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24331152

Citation

Bachmann, Alexander, et al. "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." European Urology, vol. 65, no. 5, 2014, pp. 931-42.
Bachmann A, Tubaro A, Barber N, et al. 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. Eur Urol. 2014;65(5):931-42.
Bachmann, A., Tubaro, A., Barber, N., d'Ancona, F., Muir, G., Witzsch, U., Grimm, M. O., Benejam, J., Stolzenburg, J. U., Riddick, A., Pahernik, S., Roelink, H., Ameye, F., Saussine, C., Bruyère, F., Loidl, W., Larner, T., Gogoi, N. K., Hindley, R., ... Thomas, J. A. (2014). 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. European Urology, 65(5), 931-42. https://doi.org/10.1016/j.eururo.2013.10.040
Bachmann A, et al. 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. Eur Urol. 2014;65(5):931-42. PubMed PMID: 24331152.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Bachmann,Alexander, AU - Tubaro,Andrea, AU - Barber,Neil, AU - d'Ancona,Frank, AU - Muir,Gordon, AU - Witzsch,Ulrich, AU - Grimm,Marc-Oliver, AU - Benejam,Joan, AU - Stolzenburg,Jens-Uwe, AU - Riddick,Antony, AU - Pahernik,Sascha, AU - Roelink,Herman, AU - Ameye,Filip, AU - Saussine,Christian, AU - Bruyère,Franck, AU - Loidl,Wolfgang, AU - Larner,Tim, AU - Gogoi,Nirjan-Kumar, AU - Hindley,Richard, AU - Muschter,Rolf, AU - Thorpe,Andrew, AU - Shrotri,Nitin, AU - Graham,Stuart, AU - Hamann,Moritz, AU - Miller,Kurt, AU - Schostak,Martin, AU - Capitán,Carlos, AU - Knispel,Helmut, AU - Thomas,J Andrew, Y1 - 2013/11/11/ PY - 2013/06/30/received PY - 2013/10/24/accepted PY - 2013/12/17/entrez PY - 2013/12/18/pubmed PY - 2014/11/18/medline KW - Adverse events KW - Benign prostatic obstruction (BPO) KW - Clavien-Dindo classification KW - Efficacy KW - GreenLight XPS 180-W laser KW - Photoselective vaporisation of the prostate (PVP) KW - Safety KW - TURP KW - Transurethral surgery SP - 931 EP - 42 JF - European urology JO - Eur Urol VL - 65 IS - 5 N2 - 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. DESIGN, SETTING, AND PARTICIPANTS: Prospective randomised controlled trial at 29 centres in 9 European countries involving 281 patients with BPO. INTERVENTION: 180-W GL XPS system or TURP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: 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. RESULTS AND LIMITATIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov, identifier NCT01218672. SN - 1873-7560 UR - https://www.unboundmedicine.com/medline/citation/24331152/180_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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0302-2838(13)01135-4 DB - PRIME DP - Unbound Medicine ER -