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

Abstract

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 (20-160mL) were randomized 1:1 into either DiLEP or BEEP in a dual-centre, non-inferiority-design randomized-controlled trial. The primary outcomes included Qmax and IPSS at 12 months. Non-inferiority was evaluated by comparing the two-sided 95% CI for the mean differences of Qmax 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 Qmax (28.0±7.0 vs. 28.1±7.2mL/s) and IPSS (3.0±2.2 vs. 2.9±2.6) at 12 months, the non-inferiority was met for both Qmax 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±0.75g/dL), sodium decrease (1.0±2.7 vs. 0.3±2.9mmol/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 Qmax and IPSS at 12 months postoperatively.