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

ABSTRACT

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.