Naftopidil versus flopropione as medical expulsive therapy for distal ureteral stones: results of a randomized, multicenter, double-blind, controlled trial

Purpose A multicenter, double-blind, randomized, controlled trial was conducted to determine the efficacy of naftopidil as medical expulsive therapy (MET) for patients with distal ureteral stones. Methods Ninety-two patients presenting with a single distal ureteral stone ≤10 mm were randomly assigned to receive either naftopidil (75 mg of naftopidil once in the morning and placebo twice a day) or flopropione (80 mg three times a day). The primary end point was time to stone expulsion calculated by the Kaplan–Meier method. Secondary end points were the percentages of patients who required analgesics, hospital admission, and surgery, the number of working days lost to the disease, and treatment safety. Results Overall, three patients were excluded from the final analysis. No significant differences were noted in age, stone size, and stone side between the treatment arms. The median time to stone expulsion was 8 days [95 % confidence interval (CI), 3–16] for the naftopidil group, and this was significantly less than the 18 days (95 % CI, 11 to not reached) for the flopropione group ( p = 0.03). On multivariate Cox regression analysis, the hazard of expulsion was 1.8-fold higher for the naftopidil group than for the flopropione group after adjustment for age, sex, stone side, and stone size. No significant differences were noted in the secondary end points. Conclusions The administration of naftopidil significantly improved time to stone expulsion in patients with distal ureteral stones ≤10 mm. We believe that this is the first multicenter, double-blind, randomized, controlled trial demonstrating the efficacy of naftopidil for MET.