Effectiveness of Flexible Ureterorenoscopy Versus Extracorporeal Shock Wave Lithotripsy for Renal Calculi of 5–15 mm: Results of a Randomized Controlled Trial

BACKGROUND: Primary flexible ureterorenoscopy (URS) and extracorporeal shock wave lithotripsy (SWL) are treatment options in patients with renal calculi of 5–15 mm. OBJECTIVE: To compare effectiveness, complication rates, and pain scores between primary URS and SWL. DESIGN, SETTING, AND PARTICIPANTS: Between 2011 and 2016, patients with renal calculi between 5 and 15 mm were randomized to undergo either primary URS or SWL. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Stone-free rate and size of residual fragments assessed by computed tomography after 3 mo, complications, and pain scores were evaluated. RESULTS AND LIMITATIONS: The study was prematurely closed after randomizing 44 patients due to poor accrual. The 3-mo stone-free rate and mean residual stone size were, respectively, 61% and 1.8 mm after URS and 48% and 2.4 mm after SWL. Early post-treatment pain scores were significantly higher after URS than after SWL on day 1 (3.3 vs 1.6, p = 0.02) and day 7 (5.2 vs 3.4, p = 0.04), but were no longer detectable after 3 wk and 3 mo, respectively. One Clavien-Dindo grade II complication was observed after URS (5%) and SWL (4%), while one (4%) grade IIIb complication was observed after SWL. CONCLUSIONS: URS appears to be associated with higher early post-treatment discomfort, which could be associated with routine postoperative stenting. Owing to premature closure of this trial, the power was insufficient to formally compare URS and SWL; however, the present data might be informative to counsel patients about treatment outcomes and allow future meta-analyses. PATIENT SUMMARY: This study was ended prematurely, but it contributes data about efficacy and side effects of different treatment options in patients with renal calculi.