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Zou, Zhihui; Xu, Abai; Zheng, Shaobo; Chen, Binshen; Xu, Yawen; Li, Hulin; Duan, Chongyang; Zheng, Junhong; Chen, Jiasheng; Li, Chaoming; Wang, Yiming; Gao, Yubo; Liang, Chaozhao; Liu, Chunxiao (2018): Dual-centre randomized-controlled trial comparing transurethral endoscopic enucleation of the prostate using diode laser vs. bipolar plasmakinetic for the treatment of LUTS secondary of benign prostate obstruction: 1-year follow-up results. In: World Journal of Urology, Vol. 36, No. 7: pp. 1117-1126
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Bipolar endoscopic enucleation of the prostate (BEEP) was recommended by the 2016 EAU guidelines as the first choice of surgical treatment in men with a substantially enlarged prostate and moderate-to-severe lower urinary tract symptoms. The main aim of this study was to compare a modified diode laser enucleation of the prostate (DiLEP) to BEEP. A total of 114 patients with prostate (20-160 mL) were randomized 1:1 into either DiLEP or BEEP in a dual-centre, non-inferiority-design randomized-controlled trial. The primary outcomes included Q (max) and IPSS at 12 months. Non-inferiority was evaluated by comparing the two-sided 95% CI for the mean differences of Q (max) and IPSS. Secondary endpoints included other perioperative parameters, postoperative micturition variables, and complication rate. A total of 111 patients (97%) had completed the intent-to-treat analysis, The results showed that DiLEP was comparable to BEEP regarding Q (max) (28.0 +/- 7.0 vs. 28.1 +/- 7.2 mL/s) and IPSS (3.0 +/- 2.2 vs. 2.9 +/- 2.6) at 12 months, the non-inferiority was met for both Q (max) and IPSS. There were also no significant difference between two groups regarding tissue removal rate (71.8 vs. 73.8%), hemoglobin decrease (0.33 +/- 0.66 vs. 0.36 +/- 0.75 g/dL), sodium decrease (1.0 +/- 2.7 vs. 0.3 +/- 2.9 mmol/L), and Clavien III complications (5.3 vs. 1.8%) at 12 months. This DiLEP is an anatomical endoscopic enucleation technique for the treatment of benign prostatic hyperplasia, it is non-inferior to BEEP regarding Q (max) and IPSS at 12 months postoperatively.