GOLIATH: 180-W GreenLight XPS Laser Vaporization versus Transurethral Resection of the Prostate
GOLIATH was a multicenter, open-label noninferiority randomized trial of 180-W GreenLight XPS laser photoselective vaporization of the prostate (PVP) versus monopolar or bipolar transurethral resection of the prostate (TURP) in 281 men with benign prostatic obstruction and prostates of 100 g or less, with the International Prostate Symptom Score (IPSS) at 6 months as the primary endpoint. The laser was noninferior to TURP for IPSS, maximum flow rate (Qmax) and the complication-free proportion at 6 months, with shorter catheterization and hospital stay, and noninferiority was sustained at 12 and 24 months.[1][2][3][4]
- Design and population
- Multicenter, open-label noninferiority randomized trial. Men aged 40 to 80 years with benign prostatic obstruction (IPSS 12 or higher, Qmax below 15 mL/s, prostate 100 g or less on transrectal ultrasound); 281 were randomized and 269 treated.
- Arms
- 180-W GreenLight XPS laser photoselective vaporization of the prostate versus monopolar or bipolar transurethral resection of the prostate (TURP)
- Report and follow-up
- 2013 · 6 months
| Endpoint | Results | Effect | Finding |
|---|---|---|---|
| Mean IPSS at 6 months (lower is better; laser minus TURP) | 6.8 vs 5.6 | difference 1.2 | Met |
| Mean maximum flow rate at 6 months, mL/s (laser minus TURP) | 23.3 mL/s vs 24.2 mL/s | difference -0.9 | Met |
| Proportion free of device- or procedure-related complications through 180 days (laser minus TURP) | 87.3% vs 83.2% | difference 4.1 | Met |
Design
Twenty-nine centers in 9 European countries enrolled men from April 2011. Eligible men were 40 to 80 years old with an IPSS of 12 or higher, a Qmax below 15 mL/s, a transrectal ultrasound prostate volume of 100 g or less and ASA class I to III, and were suitable candidates for either operation. Exclusions included prostate cancer, a urethral stricture or bladder neck contracture diagnosed within 180 days, neurogenic bladder, prior lower urinary tract surgery, catheterization or a postvoid residual above 400 mL in the 14 days before surgery, a bleeding disorder, inability to stop anticoagulant or antiplatelet therapy for 3 to 5 days (low-dose aspirin of 100 mg or less allowed) and myocardial infarction, open heart surgery or cardiac arrest within 180 days.[4]
Of 291 men enrolled, 10 were withdrawn as ineligible before randomization; 281 were randomized (139 to the laser, 142 to TURP) and 269 were treated (136 and 133). In the 6-month report, baseline mean age was 65.9 versus 65.4 years.[1] Mean IPSS was 21.2 versus 21.7.[2][4] Patients, surgeons and site personnel were not blinded; adverse events were adjudicated blind by an independent clinical events committee.[5]
The primary hypothesis was noninferiority of the laser to TURP for IPSS at 6 months, tested with one-sided tests at the 2.5% level and a margin of 3 IPSS points.[1] Qmax and the complication-free proportion were the other 6-month comparisons of the primary objective. A complication was a device- or procedure-related adverse event that involved perforation, prolonged or secondary hospitalization, or a surgical or invasive intervention, excluding catheterization for transient retention under 7 days.[1][3][4]
Results
At 6 months mean IPSS was 6.8 with the laser (134 patients) and 5.6 with TURP (131 patients), a difference of 1.2 points; noninferiority was demonstrated.[1][4] Mean Qmax was 23.3 versus 24.2 mL/s, and 87.3% of laser patients (134 analyzed) and 83.2% of TURP patients (131 analyzed) were free of complications through 180 days; noninferiority was demonstrated for both.[1][4] Reintervention within 30 days was three times more frequent after TURP (p = 0.025), while overall reintervention rates did not differ at 6 months.[1]
At 12 months noninferiority was maintained. Mean IPSS was 7.0 versus 5.7 (difference 1.3, 95% CI −0.1 to 2.7) and Qmax 23.0 versus 24.7 mL/s; Qmax, postvoid residual, prostate volume and PSA did not differ significantly between arms, and the complication-free rate was 84.6% versus 80.5% (p = 0.415).[2][6]
At 24 months mean IPSS was 6.9 versus 5.9 (difference 1.0, 95% CI −0.5 to 2.5), inside the 3-point margin, and Qmax was 21.6 versus 22.9 mL/s (difference −1.3, 95% CI −4.0 to 1.4).[3][7] The complication-free proportion through 24 months was 83.6% versus 78.9%.[3] The OAB-q short-form differences seen at 12 months were no longer statistically significant at 24 months (mean scores 15.3 versus 11.9).[3][4] Mean IIEF-5 was 12.9 versus 13.9 at 24 months (baseline 13.2 versus 13.7).[4]
Through 24 months there were 14 retreatment surgeries for obstruction in the laser arm (136 treated) and 10 in the TURP arm (133 treated): 4 versus 7 in months 0 to 6, 6 versus 2 in months 7 to 12, and 4 versus 1 in months 13 to 24. Kaplan-Meier estimates of reoperation by 24 months were 9.0% versus 7.6% (p = 0.7).[3][4]
Surgery and treatment delivery
The laser arm used the GreenLight XPS console (532 nm, up to 180 W) with the MoXy side-firing fiber. The TURP arm used any CE-marked monopolar or bipolar loop system; an editorial on the trial gives the split as 58.6% monopolar and 41.4% bipolar.[4][8]
Recovery favored the laser (p < 0.001 for each measure at 6 months). Median catheterization lasted 22.0 versus 46.7 hours, median time to stable health status 26.0 versus 52.8 hours and median hospital stay 49.3 versus 78.2 hours.[1][5] In the registry results, mean stay from recovery-room entry to discharge was 65.5 versus 97.8 hours.[4]
Adverse events
Through a mean follow-up of 23.3 months the registry recorded serious adverse events in 24 of 136 laser patients (17.6%) and 25 of 133 TURP patients (18.8%).[4] Serious bleeding occurred in 3 (2.2%) versus 8 (6.0%), serious stricture in 8 (5.9%) versus 7 (5.3%), serious urinary incontinence in 6 (4.4%) versus 2 (1.5%) and serious urinary retention in 5 (3.7%) versus 6 (4.5%).[4] Nonserious urinary tract infection affected 25 (18.4%) versus 12 (9.0%), irritative symptoms 30 (22.1%) versus 30 (22.6%) and bleeding 13 (9.6%) versus 13 (9.8%); nonserious urinary incontinence affected 10 (7.4%) versus 4 (3.0%).[4] At 12 months, 4 patients in each arm had unresolved urinary incontinence.[2]
Limitations
The trial was open-label because the two operations differ visibly, and the registry lists Boston Scientific as the sponsor.[4] Follow-up ended at 24 months. The editorial counted 10 laser and 3 TURP reoperations after month 6, especially for bladder neck contracture, with 4 laser and 1 TURP patient reoperated in the second year. It noted that half of the patients in both arms had prostates under 48 mL and asked for an analysis of reoperation by gland size.[8] Men who were catheterized or had a postvoid residual above 400 mL, prostates above 100 g, recent cardiac events or bleeding risk were excluded.[4]
In conversation
- Parallel to WATER (2018). Both are noninferiority randomized trials of a prostate ablation technique against TURP; WATER tested robotic waterjet resection in 30 to 80 mL prostates.
Same setting St Gallen PAE trial (2018), UNBLOCS (2020)
GOLIATH and WATER both used TURP as the comparator but enrolled different glands (100 mL or less versus 30 to 80 g), and GOLIATH's primary endpoint was IPSS at 6 months rather than IPSS reduction with a separate safety endpoint.[1][10]
Guidelines and approvals
- AUA (BPH guideline, 2026), statement 39. Clinicians should offer photoselective vaporization of the prostate as an option for patients for the treatment of LUTS/BPH . The guideline text describes the 2-year GOLIATH outcomes as maintaining noninferiority of 180-W PVP to TURP.[7]
- EAU (March 2026). Offer 180 W 532 nm LBO laser vaporisation of the prostate to men with moderate-to-severe LUTS/BPO and a prostate volume of 30 to 80 mL as an alternative to TURP . The efficacy text cites the 24-month GOLIATH report as the only available randomized trial of the 180 W laser against TURP, and the summary of evidence rates the comparable short- to mid-term results of the 180 W laser at level 1b.[9]
Report history
| Published | Report | Cutoff | Headline results | Citation |
|---|---|---|---|---|
| 2013-11-11 | 6-month safety and efficacy · primary | — | Mean IPSS at 6 months (lower is better; laser minus TURP): 6.8 vs 5.6; difference 1.2 Met Mean maximum flow rate at 6 months, mL/s (laser minus TURP): 23.3 mL/s vs 24.2 mL/s; difference -0.9 Met Proportion free of device- or procedure-related complications through 180 days (laser minus TURP): 87.3% vs 83.2%; difference 4.1 Met Reintervention within 30 days: Abstract: the early reintervention rate was three times higher after TURP; overall postoperative reintervention rates did not differ significantly between arms at 6 months.; P 0.025 Time until stable health status, length of catheterization and length of hospital stay: Abstract: all three were superior with XPS. Median values are under treatment delivery facts.; P <0.001 | 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):931-942. doi:10.1016/j.eururo.2013.10.040 DOI |
| 2014-09-16 | 12-month results · updated | — | Mean IPSS at 12 months (laser minus TURP): 7.0 vs 5.7; difference 1.3; CI -0.1–2.7 Mean maximum flow rate at 12 months, mL/s: 23.0 mL/s vs 24.7 mL/s; — Complication-free rate at 1 year (laser versus TURP): 84.6% vs 80.5%; P 0.415 | Bachmann A, Tubaro A, Barber N, et al. "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." *J Urol.* 2015;193(2):570-578. doi:10.1016/j.juro.2014.09.001 DOI |
| 2015-08-15 | 24-month outcomes · updated | — | Mean IPSS at 24 months (laser minus TURP): 6.9 vs 5.9; difference 1; CI -0.5–2.5 Met Mean maximum flow rate at 24 months, mL/s (laser minus TURP): 21.6 mL/s vs 22.9 mL/s; difference -1.3; CI -4–1.4 Met Proportion complication free through 24 months (laser minus TURP): 83.6% vs 78.9%; difference 4.7 Met Retreatment for obstruction (TURP, PVP or other intervention) through 24 months: 14 retreatment surgeries (136 treated) vs 10 retreatment surgeries (133 treated); — Mean OAB-q short form symptom bother score at 24 months (lower is better): 15.3 vs 11.9; — Mean IIEF-5 score at 24 months: 12.9 vs 13.9; — | Thomas JA, Tubaro A, Barber N, et al. "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." *Eur Urol.* 2016;69(1):94-102. doi:10.1016/j.eururo.2015.07.054 DOI |
References
1. 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):931-942. doi:10.1016/j.eururo.2013.10.040
2. Bachmann A, Tubaro A, Barber N, et al. "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." J Urol. 2015;193(2):570-578. doi:10.1016/j.juro.2014.09.001
3. Thomas JA, Tubaro A, Barber N, et al. "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." Eur Urol. 2016;69(1):94-102. doi:10.1016/j.eururo.2015.07.054
4. ClinicalTrials.gov. "Photoselective Vaporization of the Prostate With the GreenLight XPS Laser System vs TURP for the Treatment of BPH." Identifier NCT01218672. Results posted September 3, 2020. clinicaltrials.gov
5. American Medical Systems. "A European Multicenter Randomized Noninferiority Trial Comparing 180 W GreenLight XPS Laser Vaporization and Transurethral Resection of the Prostate: 12-Month Results of the GOLIATH Study" (infographic GL-01410). Minnetonka, MN: American Medical Systems; March 2015. Manufacturer material.
6. Binder SP. "Study: Safety, efficacy similar between PVP, TURP." Urology Times. August 21, 2014. urologytimes.com
7. Goueli R, Badlani GH, Welliver C, et al. Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH): AUA guideline (2026). Part III: Procedural and surgical management. J Urol. 2026;216(2):161-170. doi:10.1097/JU.0000000000005099
8. Elhilali MM, Elkoushy MA. "Greenlight laser vaporization versus transurethral resection of the prostate for the treatment of benign prostatic obstruction: evidence from randomized controlled studies." Transl Androl Urol. 2016;5(3):388-392. doi:10.21037/tau.2016.03.09
9. Cornu JN, Elterman D, Hashim H, et al. EAU Guidelines on Non-Neurogenic Male Lower Urinary Tract Symptoms (LUTS). Arnhem: EAU Guidelines Office; update March 2026. Section 5.3.3.b.
10. Gilling PJ, Barber N, Bidair M, et al. "WATER: A Double-Blind, Randomized, Controlled Trial of Aquablation® vs Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia." J Urol. 2018;199(5):1252-1261. doi:10.1016/j.juro.2017.12.065