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World Journal of Urology

, Volume 36, Issue 7, pp 1117–1126 | Cite as

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

  • 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
Original Article

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.

Keywords

Benign prostatic hyperplasia Prostatectomy Endoscopic enucleation of the prostate Laser surgery Diode laser enucleation of the prostate Randomized-controlled trial 

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

Qmax

Maximum urinary flow rate

QoL

Quality of life

RCT

Randomized-controlled trial

SCP

Surgical capsule plane

TURP

Transurethral resection of the prostate

Notes

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.

Author contributions

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.

Funding

Funded by Guangzhou Science Technology Key Program (201504301009390).

Compliance with ethical standards

Conflict of interest

The authors have nothing to disclose.

Informed consent

Written informed consent was obtained from all subjects.

Ethical approval

Ethical approval has been taken from Institutional Ethical Committee.

Supplementary material

345_2018_2229_MOESM1_ESM.wmv (44.3 mb)
Supplementary material 1 Video modified DiLEP (WMV 45398 kb)

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  • Zhihui Zou
    • 1
    • 5
  • Abai Xu
    • 1
  • Shaobo Zheng
    • 1
  • Binshen Chen
    • 1
  • Yawen Xu
    • 1
  • Hulin Li
    • 1
  • Chongyang Duan
    • 2
    • 3
  • Junhong Zheng
    • 4
  • Jiasheng Chen
    • 1
  • Chaoming Li
    • 1
  • Yiming Wang
    • 1
    • 6
  • Yubo Gao
    • 1
  • Chaozhao Liang
    • 5
  • Chunxiao Liu
    • 1
  1. 1.Department of UrologyZhujiang Hospital of Southern Medical UniversityGuangzhouChina
  2. 2.Department of Biostatistics, School of Public HealthSouthern Medical UniversityGuangzhouChina
  3. 3.State Key Laboratory of Organ Failure ResearchNational Clinical Research Centre for Kidney DiseaseGuangzhouChina
  4. 4.Department of UrologyThe Second Affiliate Hospital of Shantou University Medical CollegeShantouChina
  5. 5.Department of UrologyThe First Affiliated Hospital of Anhui Medical UniversityHefeiChina
  6. 6.Department of UrologyLudwig-Maximilians UniversityMunichGermany

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