A Prospective Multicenter Randomized Study Comparing GreenLight XPS? Laser and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Hyperplasia
CUA Online Library. Bachmann A. 06/25/13; 31354; MP-08.24
Disclosure(s): Prof. Bachmann and Dr. Andy Thomas are PI\\\'s of GOLIATH study and received honoraria for presentations and workshops of AMS. Prof. Bachmann is medical advisor of AMS.
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Title: A prospective multicenter randomized study comparing GreenLight XPS™ laser and transurethral resection of the prostate for the treatment of benign prostatic hyperplasia Authors: Bachmann A, Tubaro A, Barber N, d’Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink J, Ameye F, Thomas JA
INTRODUCTION AND OBJECTIVES: There have been very few prospective randomized trials comparing laser prostatectomy to traditional TURP for the treatment of symptomatic BPH. The objective of this study was to assess the efficacy and safety of a contemporary laser modality GreenLight XPS™ 180-W laser photovaporization (PVP) compared with transurethral resection of the prostate (TURP) in subjects with lower urinary tract symptoms secondary to benign prostatic hyperplasia.
METHODS: 291 subjects were enrolled at 29 sites in 11 European countries. Subjects were randomized to either PVP or TURP. The primary outcome of the trial was the International Prostate Symptom Score (IPSS) at 6 months post surgery. The trial was powered to demonstrate non-inferiority of PVP when compared to TURP. Other endpoints that were assessed included Qmax, PVR, PSA, prostate volume (via ultrasound) and incidence of complications.
RESULTS: 291 subjects were enrolled between April 2011 and September 2012; of whom 281 were randomized (139 PVP, 142
TURP). At six months the mean (+s.d.) IPSS score was 6.8 ± 5.3 for PVP compared to 5.5 ± 4.7 for TURP consistent with non –inferiority with the difference being 1.4 and the 95% confidence interval being 0.1-2.6. Likewise there was no difference in Qmax at 6 months 23.3 cc/s for PVP vs 24.4 cc/s for TURP. The six month complication free survival rate was greater for PVP (87.9%) than that observed for TURP (82.8%), however, this did not reach statistical significance (p=0.12). Additionally, prostate volume at 6 months was similar in the two groups.
CONCLUSIONS: To our knowledge this is the largest prospective randomized trial comparing PVP with TURP. PVP proved to be equal to TURP with respect to IPSS, Qmax, complication rate, and prostate volume.
INTRODUCTION AND OBJECTIVES: There have been very few prospective randomized trials comparing laser prostatectomy to traditional TURP for the treatment of symptomatic BPH. The objective of this study was to assess the efficacy and safety of a contemporary laser modality GreenLight XPS™ 180-W laser photovaporization (PVP) compared with transurethral resection of the prostate (TURP) in subjects with lower urinary tract symptoms secondary to benign prostatic hyperplasia.
METHODS: 291 subjects were enrolled at 29 sites in 11 European countries. Subjects were randomized to either PVP or TURP. The primary outcome of the trial was the International Prostate Symptom Score (IPSS) at 6 months post surgery. The trial was powered to demonstrate non-inferiority of PVP when compared to TURP. Other endpoints that were assessed included Qmax, PVR, PSA, prostate volume (via ultrasound) and incidence of complications.
RESULTS: 291 subjects were enrolled between April 2011 and September 2012; of whom 281 were randomized (139 PVP, 142
TURP). At six months the mean (+s.d.) IPSS score was 6.8 ± 5.3 for PVP compared to 5.5 ± 4.7 for TURP consistent with non –inferiority with the difference being 1.4 and the 95% confidence interval being 0.1-2.6. Likewise there was no difference in Qmax at 6 months 23.3 cc/s for PVP vs 24.4 cc/s for TURP. The six month complication free survival rate was greater for PVP (87.9%) than that observed for TURP (82.8%), however, this did not reach statistical significance (p=0.12). Additionally, prostate volume at 6 months was similar in the two groups.
CONCLUSIONS: To our knowledge this is the largest prospective randomized trial comparing PVP with TURP. PVP proved to be equal to TURP with respect to IPSS, Qmax, complication rate, and prostate volume.
Title: A prospective multicenter randomized study comparing GreenLight XPS™ laser and transurethral resection of the prostate for the treatment of benign prostatic hyperplasia Authors: Bachmann A, Tubaro A, Barber N, d’Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink J, Ameye F, Thomas JA
INTRODUCTION AND OBJECTIVES: There have been very few prospective randomized trials comparing laser prostatectomy to traditional TURP for the treatment of symptomatic BPH. The objective of this study was to assess the efficacy and safety of a contemporary laser modality GreenLight XPS™ 180-W laser photovaporization (PVP) compared with transurethral resection of the prostate (TURP) in subjects with lower urinary tract symptoms secondary to benign prostatic hyperplasia.
METHODS: 291 subjects were enrolled at 29 sites in 11 European countries. Subjects were randomized to either PVP or TURP. The primary outcome of the trial was the International Prostate Symptom Score (IPSS) at 6 months post surgery. The trial was powered to demonstrate non-inferiority of PVP when compared to TURP. Other endpoints that were assessed included Qmax, PVR, PSA, prostate volume (via ultrasound) and incidence of complications.
RESULTS: 291 subjects were enrolled between April 2011 and September 2012; of whom 281 were randomized (139 PVP, 142
TURP). At six months the mean (+s.d.) IPSS score was 6.8 ± 5.3 for PVP compared to 5.5 ± 4.7 for TURP consistent with non –inferiority with the difference being 1.4 and the 95% confidence interval being 0.1-2.6. Likewise there was no difference in Qmax at 6 months 23.3 cc/s for PVP vs 24.4 cc/s for TURP. The six month complication free survival rate was greater for PVP (87.9%) than that observed for TURP (82.8%), however, this did not reach statistical significance (p=0.12). Additionally, prostate volume at 6 months was similar in the two groups.
CONCLUSIONS: To our knowledge this is the largest prospective randomized trial comparing PVP with TURP. PVP proved to be equal to TURP with respect to IPSS, Qmax, complication rate, and prostate volume.
INTRODUCTION AND OBJECTIVES: There have been very few prospective randomized trials comparing laser prostatectomy to traditional TURP for the treatment of symptomatic BPH. The objective of this study was to assess the efficacy and safety of a contemporary laser modality GreenLight XPS™ 180-W laser photovaporization (PVP) compared with transurethral resection of the prostate (TURP) in subjects with lower urinary tract symptoms secondary to benign prostatic hyperplasia.
METHODS: 291 subjects were enrolled at 29 sites in 11 European countries. Subjects were randomized to either PVP or TURP. The primary outcome of the trial was the International Prostate Symptom Score (IPSS) at 6 months post surgery. The trial was powered to demonstrate non-inferiority of PVP when compared to TURP. Other endpoints that were assessed included Qmax, PVR, PSA, prostate volume (via ultrasound) and incidence of complications.
RESULTS: 291 subjects were enrolled between April 2011 and September 2012; of whom 281 were randomized (139 PVP, 142
TURP). At six months the mean (+s.d.) IPSS score was 6.8 ± 5.3 for PVP compared to 5.5 ± 4.7 for TURP consistent with non –inferiority with the difference being 1.4 and the 95% confidence interval being 0.1-2.6. Likewise there was no difference in Qmax at 6 months 23.3 cc/s for PVP vs 24.4 cc/s for TURP. The six month complication free survival rate was greater for PVP (87.9%) than that observed for TURP (82.8%), however, this did not reach statistical significance (p=0.12). Additionally, prostate volume at 6 months was similar in the two groups.
CONCLUSIONS: To our knowledge this is the largest prospective randomized trial comparing PVP with TURP. PVP proved to be equal to TURP with respect to IPSS, Qmax, complication rate, and prostate volume.
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