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…

Zhihui Zou, Abai Xu, Shaobo Zheng, Binshen Chen, Yawen Xu, Hulin Li, Chongyang Duan, Junhong Zheng, Jiasheng Chen, Chaoming Li, Yiming Wang, Yubo Gao, Chaozhao Liang, Chunxiao Liu

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 Qmaxand IPSS at 12 months. Non-inferiority was evaluated by comparing the two-sided 95% CI for the mean differences of Qmaxand 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 Qmax(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 Qmaxand 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 Qmaxand IPSS at 12 months postoperatively.