The Clinical Research Of Single-use Digital Flexible Ureteroscope On Treating Upper Urinary Tract Stones

OBJECTIVE: To clarify the efficacy and safety of a new type of single-use digital flexible ureteroscope(D-FURS)compared with a reusable D-FURS for the treatment of upper urinary stones.PATIENTS AND METHODS: In this randomized,multicenter,open-label,noninferiority trial,we randomly selected patients with renal stones to receive ureteroscopy via a single-use D-FURS(ZebraScope?,Happiness Workshop,Beijing,China)or a reusable D-FURS(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 postoperative hospital stay.The safety outcomes assessed were the presence of postoperative complications,adverse events(AEs),and serious adverse events(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 2 groups.The 1-month SFR was 77.78% for the trial group and 68.25% for the control group(two-sided 95% 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%).In the subgroup analysis,the SFR of the lower pole stones in the trial group was significantly higher than that of the control group(84.00% vs 58.33%,P = 0.047),and there was no significant difference in SFR of other positions between the two groups.There was no difference between the two groups in the operative time(42.97±19.24 min vs 41.63±17.74 min,P = 0.687),the decreased level of(7.61 vs 7.08g/L,P = 0.760),the length of postoperative hospital stay(2.03±1.27 d vs 2.06±1.05 d,P=0.878),the presence of postoperative complications(4.76% vs 1.59%,P = 0.310),the presence of AEs(38.57% vs 39.71%,P = 0.709),and the presence of SAEs(3.17% vs 4.76%,P = 0.648).CONCLUSION: The single-use D-FURS(Zebra Scope?)appears to be at least noninferior to reusable D-FURS(URF-V?)regarding the 1-month SFR,the highquality rate of images,and the eligible rate of operability.Single-use D-FURS are an effective and safe alternative to reusable D-FURS.Single-use D-FURS shows an advantage in the treatment of lower pole stones and it can provide high SFR.Therefore,we recommend that single-use D-FURS for the treatment of lower pole stones 6~20mm in diameter.