Efficacy of Naftopidil as a Medical Expulsive Therapy in Japanese Men With Ureteral Stones: A Prospective Randomized Controlled Study

BACKGROUND: Naftopidil combined with an antispasmodic agent and a supplement that facilitates stone expulsion has reportedly produced an increased rate of ureteral stone expulsion. A randomized controlled study was conducted to determine the efficacy of naftopidil as a medical expulsive therapy for male patients with ureteral stones. METHODS: Male patients (n = 500) with stones from the upper to the lower ureter were randomized to one of four groups and followed for 1 month to assess spontaneous passage of stones. The control group received only analgesics. The other three groups received daily doses of 240 mg flopropione, an antispasmodic agent and 1,350 mg extract of Quercus salicina Blume/Quercus stenophylla Makino (QS), a supplement that facilitates stone expulsion; 50 mg naftopidil; or 50 mg naftopidil in combination with 240 mg flopropione and 1,350 mg QS. Stone expulsion and characteristics were evaluated by urinalysis; kidney, ureter and bladder X-ray; ultrasound; and computed tomography. RESULTS: The probability of expulsion of ureteral stones < 6 mm increased 1.570-fold (95% confidence interval (CI): 1.039 - 2.374, P < 0.05) with naftopidil compared to control; the probability of expulsion of a lower ureteral stone < 6 mm increased 1.778-fold (95% CI: 1.066 - 2.965, P < 0.05) with naftopidil compared to control. None of the stones > 6 mm spontaneously passed. CONCLUSIONS: For relatively small ureteral stones < 6 mm, analgesic treatment combined with naftopidil would be the first choice. However, for relatively large ureteral stones > 6 mm, it appears that analgesia is sufficient for initial treatment of ureteral stone.