Abstract
Purpose: The efficacy of ureteroscopy to treat urinary stones is often less than 60%. Acoustic Enhancer is an investigational device of microparticles with a tag designed with an affinity for calcium. We evaluated safety and efficacy of ureteroscopic laser lithotripsy with and without Acoustic Enhancer Microbubble Cavitation in a randomized clinical trial. Materials and Methods: Patients with urolithiasis were randomized to ureteroscopic laser lithotripsy with or without Acoustic Enhancer. The end points were the proportion of patients without residual fragments >= 2 mm on CT 30 days post procedure (fragment-free rate) and adverse events (AEs). Results: There were 103 and 93 patients in the investigational and control groups, respectively. There was no statistical superiority between the 2 groups. The fragment-free rate was 41% and 47% in the investigational and control groups, respectively (P = .46). Residual fragment size was similar, 5.55 mm vs 5.70 mm for the investigational and control groups, respectively (P = .71). Among investigational patients treated with higher average powers >= 12 W, the fragment-free rate was 51% compared with 32% (n = 47) for the low-power group (P = .06). AEs were noted in 35% and 46% of patients in the investigational and control groups, respectively (P = .11). The total number of AEs was less for the investigational arm (P < .001). Conclusions: Although laser lithotripsy with microbubble cavitation did not increase efficacy, it was associated with significantly fewer AEs. Efficacy of microbubble cavitation may depend on laser power used. The low efficacy and high rates of AEs with ureteroscopy highlight the need for novel management approaches for urinary stones.