Objectives: To evaluate the role of tamsulosin in the clearance of fragments after extracorporeal shock wave lithotripsy (ESWL) to treat renal calculi.
Methods: In this open-label prospective randomized study conducted at our institute from 2006 to 2007, 139 patients with normal renal function and a single radiopaque renal calculus, 5-20 mm, undergoing ESWL were enrolled. All patients underwent ESWL every 3 weeks until success or for <or=3 months, whichever was earlier. They were randomly assigned to 2 groups with respect to whether they had received tamsulosin, 0.4 mg/d. The primary endpoint was the success rate, and the secondary endpoints were clearance time, sessions required for clearance, pain intensity, incidence of steinstrasse, and the need for auxiliary procedures.
Results: Of the 139 patients, 51 in group 1 and 65 in group 2 completed the requisite follow-up. The demographic profile of both groups was comparable. The success rate after 1, 2, and 3 ESWL sessions was greater in group 1 than in group 2 (52.9%, 78.4%, and 94.1% vs 30.8%, 52.3%, and 75.4%; P = .016, P = .004, and P = .007, respectively). The total days required for success (35.53 +/- 19.47 vs 47.22 +/- 23.64; P = .006), total ESWL sessions required for success (1.66 vs 2.16; P = .005), and the pain experienced (visual analog scale score 28.67 +/- 20.35 vs 47.30 +/- 24.98, respectively; P = .0001) were significantly less in group 1. Two patients in group 1 and 9 in group 2 developed steinstrasse (P = .10); conservative management was successful in 1 patient in each group (P = .345). Three patients in group 1 and 10 in group 2 required auxiliary procedures (P = .14).
Conclusions: The results of our study have shown that tamsulosin facilitates earlier clearance of fragments after ESWL to renal calculi and helps reduce the severity of the pain. It tended to facilitate spontaneous clearance of steinstrasse; however, this requires additional evaluation.