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
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 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 ± 7.2 mL/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 ± 0.75 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 Qmax and IPSS at 12 months postoperatively.
KeywordsBenign prostatic hyperplasia Prostatectomy Endoscopic enucleation of the prostate Laser surgery Diode laser enucleation of the prostate Randomized-controlled trial
Benign prostatic obstruction
Bipolar plasmakinetic endoscopic enucleation of the prostate
Diode laser enucleation of the prostate
Endoscopic enucleation of the prostate
International index of erectile function
International prostate symptom score
Lower urinary tract symptoms
Maximum urinary flow rate
Quality of life
Surgical capsule plane
Transurethral resection of the prostate
We would like to thank all the patients and surgeons, attending colleagues, study nurses in this study, thanks to the Clinical Research Associate and independent clinical events committee member of this trial.
CL: project development, data management and analysis, and manuscript editing. ZZ: project development, data analysis, manuscript writing, medical illustration design, and video edit. AX: manuscript editing and data analysis. CD: data analysis. CL and JC: data collection. CL, JZ, YX, JC, HL, YW, YG, and CL provide technical or intellectual support.
Funded by Guangzhou Science Technology Key Program (201504301009390).
Compliance with ethical standards
Conflict of interest
The authors have nothing to disclose.
Written informed consent was obtained from all subjects.
Ethical approval has been taken from Institutional Ethical Committee.
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