Photoselective Vaporization of the Prostate with GreenLight 120-W Laser Compared with Monopolar Transurethral Resection of the Prostate: A Multicenter Randomized Controlled Trial

被引:124
作者
Lukacs, Bertrand [1 ,2 ]
Loeffler, Joyce [3 ]
Bruyere, Franck [4 ]
Blanchet, Pascal
Gelet, Albert [5 ]
Coloby, Patrick [6 ]
De la Taille, Alexandre [7 ,8 ]
Lemaire, Philippe [9 ]
Baron, Jean-Christophe [10 ]
Cornu, Jean-Nicolas [1 ,2 ]
Aout, Mounir [11 ,12 ]
Rousseau, Helene [11 ,12 ]
Vicaut, Eric [11 ,12 ]
机构
[1] Hop Tenon, AP HP, Dept Urol, F-75970 Paris 20, France
[2] Univ Paris 06, Paris, France
[3] Univ Nice, Dept Urol, Pasteur Hosp, Nice, France
[4] Univ Hosp Tours, Dept Urol, Tours, France
[5] Hop Edouard Herriot, Dept Urol, Lyon, France
[6] Rene Dubos Hosp, Dept Urol, Pontoise, France
[7] Hop Edouard Herriot, AP HP, Dept Urol, Creteil, France
[8] Univ Paris 12, Creteil, France
[9] Les Bleuets Clin, Dept Urol, Reims, France
[10] Alliance Clin, Dept Urol, St Cyr Sur Loire, France
[11] Lariboisiere Fernand Widal Hosp, AP HP, Clin Res Unit, Paris, France
[12] Univ Paris Diderot, Paris, France
关键词
Transurethral resection of the prostate; Photovaporization of the prostate; Laser; Randomized controlled trial; URINARY-TRACT SYMPTOMS; CLINICAL-TRIAL; HYPERPLASIA; PVP; MEN;
D O I
10.1016/j.eururo.2012.01.052
中图分类号
R5 [内科学]; R69 [泌尿科学(泌尿生殖系疾病)];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页码:1165 / 1173
页数:9
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