MP65-19 REUSABLE DIGITAL FLEXIBLE URETEROSCOPE VS. A SINGLE-USE FLEXIBLE URETEROSCOPE IN THE TREATMENT OF UROLITHIASIS: AN EDGE CONSORTIUM PROSPECTIVE RANDOMIZED CLINICAL TRIAL

Abstract

Introduction {\&} Objective: Flexible ureteroscopes are routinely used to treat kidney stones. Both single-use and reusable models are available. The high cost of purchase and repair of reusable ureteroscopes has led to the development of single-use options. This trial compared a single-use digital flexible ureteroscope (LithoVue, Boston Scientific) to a state-of-the art reusable digital flexible ureteroscope (Flex-Xc, Storz) in a multicenter, prospective randomized trial from the EDGE Group. Method(s): Patients were randomized across 3 sites to either the single use flexible ureteroscope (n = 53) or a reusable flexible ureteroscope (n = 49) (brand new at each site and used only for study cases). Ureteroscopies were performed using a standardized technique in patients with renal stone burdens ranging from 5-20 mm. The reusable ureteroscope was used until it was damaged to the point that a major repair was required. Primary outcomes were stone-free rate 6-10 weeks post-procedure and secondary outcomes included length of surgery, laser time, basketing time, deflection of scope at the beginning and end of the case, and a rating scale of scope handling. Result(s): The mean age was 57.9 years (-13.2), 53.3{\%} male, 73{\%} Caucasian, and 77.6{\%} non-Hispanic or Latino. Upward and downward deflection was significantly better both at the beginning (p {\textless} 0.007) and end of the case (p {\textless} 0.001, Table 1) with LithoVue. Performance was comparable between scopes for all other intraoperative measures (Table 1). However, scope handling as rated by each surgeon favored the reusable ureteroscope for maneuverability (p = 0.004), visualization (p {\textless} 0.001), ability to target the laser on stone (p {\textless} 0.001), and overall scope rating (p {\textless} 0.001). There was no difference in stone free rate at 4-10 days or 6-10 weeks). The 3 reusable ureteroscopes failed and required a total of 5 repairs during the trial (2 each at OSU and Mayo, 1 at UBC) and averaged 6.6 uses before repair. Conclusion(s): The LithoVue single-use ureteroscope had better deflection angles pre-and post-operatively when compared to the reusable digital Flex-Xc. Surgeons preferred the reusable flexible ureteroscope handling and visualization, although both scopes produced similar stone free rates. The high rate of breakage of reusable ureteroscopes is concerning and the single-use ureteroscope produced equivalent patient outcomes.