Objectives: To design a randomized, no-treatment, controlled, prospective study to determine whether the administration of tamsulosin, as adjunctive medical therapy, increases the efficacy of one extracorporeal shock wave lithotripsy (ESWL) session to treat renal stones and decreases the use of analgesic drugs after the procedure.
Methods: A total of 130 patients underwent a single ESWL session to treat solitary radiopaque renal stones 4 to 20 mm in diameter. After treatment, all patients were randomly assigned to receive our standard medical therapy alone (controls) or in association with 0.4 mg tamsulosin daily for a maximum of 12 weeks. All 130 patients were followed up for 3 months or until an alternative treatment was given.
Results: Of the 130 patients, 78.5% of those receiving tamsulosin and 60% of controls had achieved clinical success at 3 months (P = 0.037). When we stratified patients according to stone size, for those with a stone size larger than 10 mm, the success rate was significantly greater in the tamsulosin group (P = 0.028). Renoureteral colic occurred in 76.9% of patients treated with standard therapy but in only 26.1% of those receiving tamsulosin (P < 0.001). The mean cumulative diclofenac dose was 375 mg per patient in the tamsulosin group and 675 mg per patient in the control group (P < 0.001).
Conclusions: The results of our study have demonstrated that tamsulosin therapy, as an adjunctive medical therapy after ESWL, is more effective than lithotripsy alone for the treatment of patients with large renal stones and is equally safe. In addition, our results also indicated that adjunctive treatment with tamsulosin could decrease the use of analgesic drugs after ESWL.