Abstract
Purpose
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.
Methods
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.
Results
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.
Conclusions
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.
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Abbreviations
- BPO:
-
Benign prostatic obstruction
- BEEP:
-
Bipolar plasmakinetic endoscopic enucleation of the prostate
- DiLEP :
-
Diode laser enucleation of the prostate
- EEP:
-
Endoscopic enucleation of the prostate
- IIEF-5:
-
International index of erectile function
- IPSS:
-
International prostate symptom score
- LUTS:
-
Lower urinary tract symptoms
- OP:
-
Open prostatectomy
- PSA:
-
Prostate-specific antigen
- PV:
-
Prostate volume
- PVR:
-
Postvoid residual
- Q max :
-
Maximum urinary flow rate
- QoL:
-
Quality of life
- RCT:
-
Randomized-controlled trial
- SCP:
-
Surgical capsule plane
- TURP:
-
Transurethral resection of the prostate
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Acknowledgements
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.
Funding
Funded by Guangzhou Science Technology Key Program (201504301009390).
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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.
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Written informed consent was obtained from all subjects.
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Zou, Z., Xu, A., Zheng, S. et al. 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. World J Urol 36, 1117–1126 (2018). https://doi.org/10.1007/s00345-018-2229-3
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DOI: https://doi.org/10.1007/s00345-018-2229-3