Abstract
Background: To compare the efficacy and safety of a single-use digital flexible ureteroscope (FURS) and a reusable FURS for the treatment of lower pole stones (LPS) smaller than 20 mm.Methods: A prospective case-control study was conducted using the clinical data from a multicenter, randomized, open-label clinical trial in four hospitals in China. A single-use digital FURS ZebraScope™ was utilized in the trial group during surgery, with a reusable FURS URF-V used in the control group. The efficacy endpoints assessed were the 1-month postsurgical stone-free rate (SFR), operative time, length of postoperative hospital stay, and mean reduction in hemoglobin level. The safety outcomes assessed were the presence of adverse events (AEs), severe AEs (SAEs), and postoperative complications.Results: In total, 49 patients with LPS underwent surgery using FURS. The demographic and preoperative parameters were comparable between the 2 groups. The 1-month SFR was 84.00% for the ZebraScope™ group and 58.33% for the URF-V group (P<0.05). There was no difference between the two groups in the operative time (P=0.665), the length of hospital stay (P=0.308), the presence of postoperative complications (P=0.307), the presence of AEs (P=0.483),and the presence of SAEs (P = 0.141). Conclusions: This study demonstrates that single-use digital FURS is a safe and effective option and can offer higher SFR than the reusable FURS in the treatment of LPS smaller than 20 mm. We recommend single-use digital FURS as an alternative to reusable FURS for the treatment of LPS.Trial registration: The trial was registered in Chinese Clinical Trial Registry. The registration number: ChiCTR1900021615. Date of registration: 1/3/2019. This trial was registered retrospectively.