Prospective evaluation of efficacy, safety, cumulative laser energy, and stone-free rates in the post-market SOLTIVE™ SuperPulsed laser system registry: insights from team of worldwide endourological researchers’ (T.O.W.E.R.) research consortium

The Thulium fiber laser (TFL) is a relatively new tool for endoscopic laser lithotripsy. The Endourological Society's T.O.W.E.R. registry sought to evaluate the stone-free rate (SFR) at 3 months following URS. A subset of the study sought to determine the association between cumulative TFL energy and SFRs. 423 patients with planned ureteroscopic lithotripsy using TFL (SOLTIVE^™, Gyrus ACMI, Inc. d/b/a Olympus Surgical Technologies America) were prospectively enrolled between December 2020 and May 2023 at nine international sites. Baseline clinical characteristics and SFR data for kidney and ureteral stones were separately analyzed according to quartile cumulative TFL energy ranges. Median patient age was 58.0 (IQR: 44-67) years and maximal stone diameters were 9.9 (IQR: 7-12.9) mm and 7.4 (IQR 6.1-9.4) mm for kidney and ureteral stones, respectively. Overall SFR (no fragments) for renal and ureteral stones were 73.0% and 85.7% at 3-months. Cumulative energy levels were divided into quartiles and lower SFRs were observed with the highest quartile for kidney stones (p = 0.001), but not in ureteral stones. This correlated with kidney stone size as larger stones required more energy. The rate of adverse events related to the procedure was 1.9% (8/423). Higher stone burdens had lower stone free rates and required more cumulative laser energy. The TFL is effective in endoscopic lithotripsy. This post-marketing survey demonstrates that TFL is a safe and effective tool for endoscopic laser lithotripsy.