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.

PURPOSE: 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. MATERIALS AND 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.

The Continuing Story of the Cost-Effectiveness of Photoselective Vaporization of the Prostate versus Transuretheral Resection of the Prostate for the Treatment of Symptomatic Benign Prostatic Obstruction.

BACKGROUND: In 2008, a UK assessment of technologies for benign prostatic obstruction concluded negatively about photoselective vaporization of the prostate (PVP), and the 2010 National Institute for Health and Care Excellence guidance caused several UK institutions to abandon PVP. OBJECTIVE: To reassess the costs and effects of PVP versus transurethral resection of the prostate (TURP) on the basis of most recent data. METHODS: The same model was used as in 2008. Transition probabilities were estimated using a Bayesian approach updating the 2008 estimates with data from two meta-analyses and data from GOLIATH, the latest and largest trial comparing PVP with TURP. Utility estimates were from the 2008 assessment, and estimates of resource utilization and costs were updated. Effectiveness was measured in quality-adjusted life-years gained, and costs are in UK pounds. The balance between costs and effects was addressed by multivariate sensitivity analysis. RESULTS: If the 2010 National Institute for Health and Care Excellence analysis would have updated the cost-effectiveness analysis with figures from its own meta-analysis, it would have estimated the change in quality-adjusted life-years at -0.01 (95% confidence interval [CI] -0.05 to 0.01) instead of at -0.11 (95% CI -0.31 to -0.01) as in the 2008 analysis. The GOLIATH estimate of -0.01 (95% CI -0.07 to 0.02) strengthens the conclusion of near equivalence. Estimates of additional costs vary from £491 (£21-£1286) in 2008 to £111 (-£315 to £595) for 2010 and to £109 (-£204 to £504) for GOLIATH. PVP becomes cost saving if more than 32% can be carried out as a day case in the United Kingdom. CONCLUSIONS: The available evidence indicates that PVP can be a cost-effective alternative for TURP in a potentially broad group of patients.

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.

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.