Elsevier

European Urology

Volume 61, Issue 6, June 2012, Pages 1165-1173
European Urology

Platinum Priority – Benign Prostatic Hyperplasia
Editorial by Stephan Madersbacher on pp. 1174–1176 of this issue
Photoselective Vaporization of the Prostate with GreenLight 120-W Laser Compared with Monopolar Transurethral Resection of the Prostate: A Multicenter Randomized Controlled Trial

https://doi.org/10.1016/j.eururo.2012.01.052Get rights and content

Abstract

Background

Evidence supporting the widespread use of GreenLight High Performance System (HPS) 120-W photoselective vaporization of the prostate (PVP) is lacking.

Objective

To assess the noninferiority of PVP compared with transurethral resection of the prostate (TURP) on urinary symptoms and the superiority of PVP over TURP on length of hospital stay.

Design, setting, and participants

A multicenter randomized controlled trial was conducted.

Intervention

Patients underwent monopolar TURP or PVP with the GreenLight HPS 120-W laser.

Measurements

International Prostate Symptom Score (IPSS), Euro-QOL questionnaire, uroflowmetry, Danish Prostate Symptom Score Sexual Function Questionnaire, sexual satisfaction, and adverse events were collected at 1, 3, 6, and 12 mo. The two groups were compared using the 95% confidence interval (CI) of median difference for testing noninferiority of the IPSS at 12 mo and the student t test for testing the difference in length of hospital stay.

Results and limitations

A total of 139 patients (70 vs 69 men in each group) were randomized. Median IPSS scores at 12-mo follow-up were 5 (interquartile range [IQR]: 3–8) for TURP versus 6 (IQR: 3–9) for PVP, and the 95% CI of the difference of the median was equal to −2 to 3. Because the upper limit of the 95% CI was >2 (the noninferiority margin), the hypothesis of noninferiority could not be considered demonstrated. Median length of stay was significantly shorter in the PVP group than in the TURP group, with a median of 1 (IQR: 1–2) versus 2.5 (IQR: 2–3.5), respectively (p < 0.0001). Uroflowmetry parameters and complications were comparable in both groups. Sexual outcomes were slightly better in the PVP group without reaching statistical significance.

Conclusions

The present study failed to demonstrate the noninferiority of 120-W GreenLight PVP versus TURP on prostate symptoms at 1 yr but showed that PVP was associated with a shorter length of stay in the hospital.

Trial registration

NCT01043588.

Introduction

Benign prostatic hyperplasia (BPH) is a highly prevalent disease, and its management represents an important economic burden in Western countries [1]. BPH is the major etiology of lower urinary tract symptoms (LUTS) in men >50 yr of age. These symptoms are usually assessed by the International Prostate Symptom Score (IPSS) and associated with a variable degree of bother. In cases of moderate to severely bothersome symptoms, medical treatment is appropriate. Surgical therapy, aiming at relieving obstruction, is indicated after the failure of maximal drug therapy or with complications of the disease [2]. Transurethral resection of the prostate (TURP) remains the reference standard, with which any new surgical innovation should be compared [3].

Photoselective vaporization of the prostate (PVP) by GreenLight laser has been presented as a minimally invasive surgical alternative to TURP, with several advantages such as reduced bleeding complications and short hospital stay [4], [5], [6]. However, PVP cannot be yet recommended as a first-line therapy because comparative studies against TURP, especially with the High Performance System (HPS) 120-W power device, are still lacking [3]. Only two monocentric randomized controlled trials (RCTs) focused on urinary parameters have been published with the GreenLight HPS 120-W laser [4], [7]. Several issues remain unclear concerning PVP such as postoperative irritative symptoms [8], sexual outcomes, and the absence of pathologic material after the procedure resulting in the missed diagnosis of prostate cancer.

Our primary goal was to compare the efficacy of PVP with GreenLight and TURP through a noninferiority hypothesis. The secondary aims were to compare adverse events, sexual outcomes, and quality of life after the two procedures.

Section snippets

Study overview

This multicenter RCT was conducted in nine tertiary reference centers from 2009 to 2011. This study was conducted in accordance with the Good Clinical Practice Guidelines and the Declaration of Helsinki. The protocol was approved by our local institutional review board. All participants gave written informed consent before enrollment. This study was funded by a national grant for medical research (assessment of emerging medical therapies program, [STIC2007], French Ministry of Health).

Participants

Patients

Population

A total of 139 men were randomized and described in the baseline data (Table 3). Three patients were not treated (two because they did not come to the hospital for the operation and one because of a contraindication to anesthesia). For all outcomes, the ITT analysis was then conducted on 136 patients who had at least one complete follow-up evaluation (68 men in both groups). IPSS at 12-mo follow-up was available in 125 patients. Figure 2 presents the flowchart.

Primary outcome

IPSS values at 12 mo-follow-up

Discussion

More evidence is needed to support the diffusion of the PVP technique as a first-line alternative to TURP [3]. The present study, as the first multicenter RCT comparing PVP and TURP, offers strong evidence that PVP and TURP efficacy are comparable in relieving symptoms of LUTS/BPH.

Like the two other RCTs available in the literature [4], [7], IPSS scores were not statistically different between the two groups after 1-yr follow-up. But the absence of a significant difference should not be

Conclusions

Although the noninferiority between the two techniques could not be formally demonstrated regarding the preestablished criteria of the present study, PVP seems an acceptable alternative to TURP with close results on LUTS improvement in the short term. PVP is associated with a reduced hospital stay with less postoperative irrigation and hematuria. Postoperative symptoms and complications were similar in both arms. Longer follow-up studies are required to confirm the clinical benefits of this

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