Prospective randomized trial comparing the efficacy of tamsulosin and tamsulosin combined with nifedepine for the management of lower ureteral stones

Abstract

Abstract

Objective: To evaluate the efficacy of tamsulosin compared to the combination of tamsulosin with nifedepine for the management of lower ureteral calculi less than 1 cm in size. 

Material and Methods: This study included 150 patients with stones <1 cm in size located in the lower ureter. The patients were divided into three groups. Group 1- Patients (N-50) received 0.4 g tamsulosin once daily. Group 2- Patients (n-50) received 0.4 g tamsulosin once daily with cap. nifedepine (5 mg) twice daily. Group 3- Patients (n-50) received placebo treatment (control group). The patients received an injection of diclofenac/injected hyoscine butyl bromide as necessary. Follow-up was performed at 6 weeks.

Results: The average stone size was similar among the three groups (6.40, 6.75 and 6.25 mm in Groups 1, 2 and 3, respectively). After treatment with medication, stone expulsion was noted in 37 of 50 patients in group 1 (74%), 43 of 50 patients in group 2 (86%), and 15 of 50 patients in group 3 (30%). The average time required for expulsion of the stone in groups 1, 2, and 3 was 28.5 days, 20.5 days, and 37.7 days, respectively. The results were superior in group 1 and group 2 compared to group 3 (placebo). A significantly higher rate of expulsion was noted in group 2 compared to group 1 (12% more expulsion compared to group 1). However, postural hypotension was noted in 3 patients in group 2 but was not so severe as to require dropping these patients from the study. 

Conclusion: Study reveals that lower ureteral stones less than 1 cm. can be effectively managed by medical management. We have found that for this purpose combination therapy by tamsulosin with nifedipine is more effective than monotherapy by tamsulosin.