PMID- 31432716
OWN - NLM
STAT- MEDLINE
DCOM- 20210107
LR  - 20210107
IS  - 1557-900X (Electronic)
IS  - 0892-7790 (Linking)
VI  - 34
IP  - 1
DP  - 2020 Jan
TI  - Single-Use Versus Reusable Digital Flexible Ureteroscopes for the Treatment of 
      Renal Calculi: A Prospective Multicenter Randomized Controlled Trial.
PG  - 18-24
LID - 10.1089/end.2019.0473 [doi]
AB  - Objective: To compare the efficacy and safety of a single-use digital flexible 
      ureteroscope (f-URS) and a reusable digital f-URS (URF-V) for the treatment of 
      renal stones in adults. Patients and Methods: In this randomized open-label 
      noninferiority trial, we randomly selected patients with renal stones to receive 
      ureteroscopy through a single-use digital f-URS (ZebraScope(); Happiness 
      Workshop, Beijing, China) or a URF-V (Olympus, Tokyo, Japan). The primary 
      endpoint was the 1-month postsurgical stone-free rate (SFR). The secondary 
      efficacy endpoints assessed were the high-quality rate of images, the eligible 
      rate of operability, the operative time, and the length of hospital stay. The 
      safety outcomes assessed were the presence of postoperative complications, 
      adverse events (AEs), and serious AEs (SAEs). The noninferiority margin was set 
      at -10%. Results: In total, 126 patients completed the study (i.e., 63 patients 
      in each group). The demographic and preoperative parameters were comparable 
      between the two groups. The 1-month SFR was 77.78% for the ZebraScope group and 
      68.25% for the URF-V group (two-sided 95% confidence interval [CI]: -5.95 to 
      25.01). The high-quality rate of images and the eligible rate of operability were 
      100% in both groups (two-sided 95% CI: -5.27 to 5.35). There was no difference 
      between the two groups in the operative time (p = 0.687), the length of hospital 
      stay (p = 0.430), the presence of postoperative complications (p = 0.310), the 
      presence of AEs (p = 0.709), and the presence of SAEs (p = 0.648). The most 
      important and fatal SAE was acute urinary tract obstruction. Conclusion: The 
      single-use digital f-URS (ZebraScope) appears to be at least noninferior to URF-V 
      regarding the 1-month SFR, the high-quality rate of images, and the eligible rate 
      of operability. Single-use digital f-URSs are an effective and safe alternative 
      to URF-V.
FAU - Qi, Shiyong
AU  - Qi S
AD  - Department of Urology, Tianjin Institute of Urology, The Second Hospital of 
      Tianjin Medical University, Tianjin, China.
FAU - Yang, Enguang
AU  - Yang E
AD  - Key Laboratory of Gansu Province for Urological Diseases, Gansu Nephro-Urological 
      Clinical Center, Institute of Urology, Lanzhou University Second Hospital, 
      Lanzhou, China.
FAU - Bao, Junsheng
AU  - Bao J
AD  - Key Laboratory of Gansu Province for Urological Diseases, Gansu Nephro-Urological 
      Clinical Center, Institute of Urology, Lanzhou University Second Hospital, 
      Lanzhou, China.
FAU - Yang, Ningqiang
AU  - Yang N
AD  - Key Laboratory of Gansu Province for Urological Diseases, Gansu Nephro-Urological 
      Clinical Center, Institute of Urology, Lanzhou University Second Hospital, 
      Lanzhou, China.
FAU - Guo, Hongfeng
AU  - Guo H
AD  - Department of Urology, Peking University Shougang Hospital, Beijing, China.
FAU - Wang, Gang
AU  - Wang G
AD  - Department of Urology, Peking University Shougang Hospital, Beijing, China.
FAU - Li, Ningchen
AU  - Li N
AD  - Department of Urology, Peking University Shougang Hospital, Beijing, China.
FAU - Cui, Xin
AU  - Cui X
AD  - Department of Urology, Capital Medical University, Beijing Xuanwu Hospital, 
      Beijing, China.
FAU - Gao, Wei
AU  - Gao W
AD  - Department of Urology, Capital Medical University, Beijing Xuanwu Hospital, 
      Beijing, China.
FAU - Ou, Tongwen
AU  - Ou T
AD  - Department of Urology, Capital Medical University, Beijing Xuanwu Hospital, 
      Beijing, China.
FAU - Wang, Jiaji
AU  - Wang J
AD  - Key Laboratory of Gansu Province for Urological Diseases, Gansu Nephro-Urological 
      Clinical Center, Institute of Urology, Lanzhou University Second Hospital, 
      Lanzhou, China.
FAU - Wang, Zhiping
AU  - Wang Z
AD  - Key Laboratory of Gansu Province for Urological Diseases, Gansu Nephro-Urological 
      Clinical Center, Institute of Urology, Lanzhou University Second Hospital, 
      Lanzhou, China.
FAU - Niu, Yuanjie
AU  - Niu Y
AD  - Department of Urology, Tianjin Institute of Urology, The Second Hospital of 
      Tianjin Medical University, Tianjin, China.
LA  - eng
PT  - Comparative Study
PT  - Equivalence Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20191004
PL  - United States
TA  - J Endourol
JT  - Journal of endourology
JID - 8807503
SB  - IM
CIN - J Endourol. 2020 Jan;34(1):25. PMID: 31595780
MH  - Adult
MH  - Aged
MH  - China/epidemiology
MH  - *Equipment Reuse
MH  - Female
MH  - Humans
MH  - Kidney Calculi/epidemiology/*surgery
MH  - Length of Stay
MH  - Male
MH  - Middle Aged
MH  - Operative Time
MH  - Postoperative Complications/etiology
MH  - Prospective Studies
MH  - Treatment Outcome
MH  - Ureteroscopes/*adverse effects
MH  - Ureteroscopy/*instrumentation
OTO - NOTNLM
OT  - efficiency
OT  - randomized controlled trial
OT  - renal calculi
OT  - ureteroscopy
EDAT- 2019/08/23 06:00
MHDA- 2021/01/08 06:00
CRDT- 2019/08/22 06:00
PHST- 2019/08/23 06:00 [pubmed]
PHST- 2021/01/08 06:00 [medline]
PHST- 2019/08/22 06:00 [entrez]
AID - 10.1089/end.2019.0473 [doi]
PST - ppublish
SO  - J Endourol. 2020 Jan;34(1):18-24. doi: 10.1089/end.2019.0473. Epub 2019 Oct 4.