ABSTRACT
OBJECTIVE: To determine the efficacy of the tamsulosin oral controlled absorption system as an adjuvant therapy to extracorporeal shock wave lithotripsy (ESWL) for the expulsion of ureteral and renal stones. METHODS: A consecutive sample of 248 patients with ureteral or renal stones who underwent ESWL in an academic hospital was included in a 12-week, prospective, open-label, randomized clinical trial. Of the 248 patients, 186, including 77 with ureteral stones (mean size 9 mm) and 109 with renal stones (mean size 13 mm) completed the study. After successful ESWL, the patients were randomized to standard medical care (corticosteroids and analgesics) or standard care plus the tamsulosin oral controlled absorption system 0.4 mg/d for 1 month. The stone clearance rate, interval to the elimination of stone fragments, incidence of renal colic, and the need for rehospitalization were assessed at 4, 8, and 12 weeks. RESULTS: The stone clearance rate was significantly greater for the patients treated with tamsulosin than for those in the standard care group at 4 (73.4% vs 55.9%, respectively; P < .001) and 12 (91.3% vs 74.6%, respectively; P < .05) weeks. Tamsulosin treatment was also associated with a significantly lower interval to the elimination of stone fragments (P < .001), a significantly lower rehospitalization rate (P < .001), and a significantly lower proportion of patients with acute renal colic (P < .05) than standard care alone. No severe adverse events leading to treatment discontinuation were observed. CONCLUSION: Adjuvant treatment with tamsulosin, in addition to standard treatment with steroids and analgesics, improved the outcome of ESWL.
