Multi-institutional Prospective Randomized Control Trial of Novel Intracorporeal Lithotripters: ShockPulse-SE vs TrilogyTM Trial.

INTRODUCTION Currently, there are multiple intracorporeal lithotripters available for use in percutaneous nephrolithotomy (PCNL). This study aimed to evaluate the efficiency of two novel lithotripters; TrilogyTM and ShockPulse-SE. METHODS This is a prospective, multi-institutional, randomized trial comparing outcomes of PCNL using two novel lithotripters between February 2019 and June 2020. The study assessed objective measures of stone clearance time, stone clearance rate, device malfunction, stone-free rates, and complications. Device assessment was provided via immediate postoperative survey by primary surgeons. RESULTS There were 100 standard PCNLs completed using either a TrilogyTM or ShockPulse-SE lithotrite. Using quantitative Stone Analysis Software to estimate stone volume, the mean stone volume was calculated at 4.18 ± 4.79 cm3 and 3.86 ± 3.43 cm3 for the Trilogy and ShockPulse-SE groups respectively . Stone clearance rates were found to be 1.22 ± 1.67 and 0.77 ± 0.68 cm3/min for TrilogyTM versus ShockPulse-SE (p=0.0542). When comparing TrilogyTM to ShockPulse-SE in a multivariate analysis, total OR time (104.4 ± 48.2 vs 121.1 ± 59.2 min p=0.126), rates of secondary procedures (17.65% vs 40.81% p=0.005), and device malfunctions (1.96% vs 34.69% p<0.001), were less, respectively. There was no difference in final stone free rates between devices. CONCLUSION The TrilogyTM lithotripter removed stones significantly faster than previous generations of intracorporeal lithotripters. In the case of large stones the efficiency of the TrilogyTM device optimizes clearance and operating times.