Single-Use Digital Flexible Ureteroscopes as a Safe and Effective Choice for the Treatment of Lower Pole Renal Stones: Secondary Analysis of a Randomized-Controlled Trial.

Abstract

Objective: 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. Patients and Methods: We analyzed the data of 49 patients with LPS from our previous multicenter, randomized, open-label clinical trial in four hospitals in China. All patients underwent FURS for LPS with a single-use FURS ZebraScope™ (trial group) or a reusable FURS URF-V (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: The demographic and preoperative parameters were comparable between the two groups. The 1-month SFR was 84.00% for the ZebraScope group and 58.33% for the reusable flexible ureteroscope (URF-V) group (p < 0.05). There was no difference between the two groups in the operative time (p = 0.665), length of hospital stay (p = 0.308), presence of postoperative complications (p = 0.307), 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. The Clinical Trial Registration number: ChiCTR1900021615.