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. © 2013 European Association of Urology.
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 / Bachmann, Alexander; Tubaro, Andrea; Barber, Neil; D'Ancona, Frank; Muir, Gordon; Witzsch, Ulrich; Grimm, Marc-Oliver; Benejam, Joan; Stolzenburg, Jens-Uwe; Riddick, Antony; Pahernik, Sascha; Roelink, Herman; Ameye, Filip; Saussine, Christian; Bruyère, Franck; Loidl, Wolfgang; Larner, Tim; Gogoi, Nirjan-Kumar; Hindley, Richard; Muschter, Rolf; Thorpe, Andrew; Shrotri, Nitin; Graham, Stuart; Hamann, Moritz; Miller, Kurt; Schostak, Martin; Capitán, Carlos; Knispel, Helmut; Thomas, J. Andrew. - In: EUROPEAN UROLOGY. - ISSN 0302-2838. - 65:5(2014), pp. 931-942. [10.1016/j.eururo.2013.10.040]
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
Tubaro, Andrea;
2014
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. © 2013 European Association of Urology.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
