A multicentre, prospective, randomized trial: comparative efficacy of tamsulosin and nifedipine in medical expulsive therapy for distal ureteric stones with renal colic.

OBJECTIVE: • To determine the comparative efficacy of tamsulosin and nifedipine in medical expulsive therapy (MET) for distal ureteric stones with renal colic. PATIENTS AND METHODS: • We evaluated the comparative efficacy of tamsulosin and nifedipine in MET in a prospective randomized trial of 3189 outpatients from 10 centres in China. • Eligible patients randomly received tamsulosin or nifedipine. Efficacies of the two agents in MET were compared at 4 weeks. • The primary endpoint was overall stone-expulsion rate. • Secondary endpoints were stone-expulsion time, rate of pain relief therapy, mean analgesic consumption for renal colic recurrence, and side-effects incidence.
RESULTS: • Stone-expulsion rates in the tamsulosin group (group 1) were greater than those in the nifedipine group (group 2; P < 0.01). • There was a significant variation in stone-expulsion rates and times between groups 1 and 2 (P < 0.01); with improvements in stone-expulsion rate and time significantly better in group 1 than in group 2. • There was a significant variation in the rate of pain relief therapy for renal colic recurrence between groups 1 and 2 (P < 0.01); patients in group 1 required significantly less analgesics than those in group 2 (P < 0.01). • There were no statistically significant differences in side-effects incidence between the groups.
CONCLUSIONS: • Administration of tamsulosin and nifedipine in MET was determined to be safe and effective for distal ureteric stones with renal colic. • Tamsulosin was significantly better than nifedipine in relieving renal colic and facilitating ureteric stone expulsion.

RCT Entities:   Population Interventions Outcomes