Shiyong Qi1, Enguang Yang2, Junsheng Bao2, Ningqiang Yang2, Hongfeng Guo3, Gang Wang3, Ningchen Li3, Xin Cui4, Wei Gao4, Tongwen Ou4, Jiaji Wang2, Zhiping Wang2, Yuanjie Niu1. 1. Department of Urology, Tianjin Institute of Urology, The Second Hospital of Tianjin Medical University, Tianjin, China. 2. Key Laboratory of Gansu Province for Urological Diseases, Gansu Nephro-Urological Clinical Center, Institute of Urology, Lanzhou University Second Hospital, Lanzhou, China. 3. Department of Urology, Peking University Shougang Hospital, Beijing, China. 4. Department of Urology, Capital Medical University, Beijing Xuanwu Hospital, Beijing, China.
Abstract
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 receiveureteroscopy 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.
RCT Entities:
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.
Authors: Ahmed I Ali; Amr Eldakhakhny; Abdelsalam Abdelfadel; Mahmoud F Rohiem; Mohamed Elbadry; Ali Hassan Journal: World J Urol Date: 2022-07-27 Impact factor: 3.661
Authors: Eduardo Mazzucchi; Giovanni Scala Marchini; Fernanda Christina Gabrigna Berto; John Denstedt; Alexandre Danilovic; Fabio Carvalho Vicentini; Fabio Cesar Miranda Torricelli; Carlos Alfredo Battagello; Miguel Srougi; William Carlos Nahas Journal: Int Braz J Urol Date: 2022 May-Jun Impact factor: 3.050