Randomized Controlled Trial to Compare the Safety and Efficacy of Naftopidil and Tamsulosin as Medical Expulsive Therapy in Combination With Prednisolone for Distal Ureteral Stones

PURPOSE To compare the safety and efficacy of naftopidil and tamsulosin with prednisolone as medical expulsive therapy for distal ureteric stones. MATERIALS AND METHODS Between July 2010 and March 2012, 120 adult patients presenting with distal ureteric stones of size 5 to 10 mm were randomized equally to tamsulosin (group A), naftopidil (group B) or watchful waiting (group C). Tamsulosin or naftopidil was given for a maximum of four weeks. In addition patients in group A and B were given 5 mg prednisolone once daily (maximum one week). Stone expulsion rate, time to stone expulsion, analgesic use, number of hospital visits for pain, follow-up and endoscopic treatment and adverse effects of drugs were noted. Statistical analyses were done using chi-square test, Mann-Whitney test and analysis of variance. RESULTS There was a statistically higher expulsion rate in groups A (70%) and B (87.5%) as compared to group C (32.5%) (p<0.001). The expulsion rates were not statistically different between groups A and B (p=0.056). The mean time to expulsion was comparable between groups A and B but longer in group C. Analgesic use was significantly lower in groups A and B. Average number of hospital visits for pain, follow-up and endoscopic treatment was similar in all groups. There was no serious adverse event. CONCLUSIONS Medical expulsive therapy for the distal ureteric stones using either naftopidil or tamsulosin in combination with prednisolone is safe and efficacious.