OBJECTIVE: To evaluate, in a prospective randomized pilot study, the effectiveness and safety of tamsulosin, administered in patients with distal ureteric stones and who have already undergone an unsuccessful first cycle of medical expulsive therapy (MET). PATIENTS AND METHODS: We evaluated the effectiveness and safety of tamsulosin, administered as a further therapy, in patients previously unsuccessfully treated with combined expulsive 10-day therapy (tamsulosin + deflazacort) for distal ureteric stones. Ninety-one patients were enrolled and randomized into two groups, each receiving a different therapy for 10 days. Group A (46 patients) received a further cycle of tamsulosin (0.4 mg daily), and group B (45) did not. Age, gender, stone size, time to expulsion, number of acute episodes of colic during treatment and analgesic consumption were recorded. Patients who were not stone-free after the study period had ureteroscopy. The results were compared statistically using Student's t-, chi-square test and Fisher's exact test. RESULTS: The groups were comparable in age, gender and stone size (5.93 mm for group A and 6.03 mm for group B). The expulsion rate was significantly higher in group A (80%) than in group B (49%) (P < 0.01), whilst there were no differences between the groups in the number of colic episodes and analgesic use. There were no reported side-effects of medical therapy. CONCLUSIONS: A second cycle of 10 days of MET with tamsulosin in nonresponders to a 10-day first cycle of MET with tamsulosin and deflazacort is safe and effective, and therefore should be considered as an option in the management of uncomplicated distal ureteric stones.
RCT Entities:
OBJECTIVE: To evaluate, in a prospective randomized pilot study, the effectiveness and safety of tamsulosin, administered in patients with distal ureteric stones and who have already undergone an unsuccessful first cycle of medical expulsive therapy (MET). PATIENTS AND METHODS: We evaluated the effectiveness and safety of tamsulosin, administered as a further therapy, in patients previously unsuccessfully treated with combined expulsive 10-day therapy (tamsulosin + deflazacort) for distal ureteric stones. Ninety-one patients were enrolled and randomized into two groups, each receiving a different therapy for 10 days. Group A (46 patients) received a further cycle of tamsulosin (0.4 mg daily), and group B (45) did not. Age, gender, stone size, time to expulsion, number of acute episodes of colic during treatment and analgesic consumption were recorded. Patients who were not stone-free after the study period had ureteroscopy. The results were compared statistically using Student's t-, chi-square test and Fisher's exact test. RESULTS: The groups were comparable in age, gender and stone size (5.93 mm for group A and 6.03 mm for group B). The expulsion rate was significantly higher in group A (80%) than in group B (49%) (P < 0.01), whilst there were no differences between the groups in the number of colic episodes and analgesic use. There were no reported side-effects of medical therapy. CONCLUSIONS: A second cycle of 10 days of MET with tamsulosin in nonresponders to a 10-day first cycle of MET with tamsulosin and deflazacort is safe and effective, and therefore should be considered as an option in the management of uncomplicated distal ureteric stones.