Is there a role for tamsulosin in the treatment of distal ureteral stones

38 Background 39 Numerous randomised trials have confirmed the efficacy of medical expulsive therapy with 40 tamsulosin in patients with distal ureteral stones. However, to date, no randomised, double41 blind, placebo-controlled trials have been performed. 42 Objective 43 The objective of this trial was to evaluate the efficacy of medical expulsive therapy with 44 tamsulosin in a randomised, double-blind, placebo-controlled setting. 45 Design, Setting, and Participants 46 Patients presenting with single distal ureteral stones ≤7mm were included in this trial. 47 Intervention 48 Patients were randomised in a double-blind fashion to receive either tamsulosin or placebo 49 for 21 days. The medication was discontinued either after stone expulsion or intervention. 50 Abdominal computed tomography was performed to assess the initial and final stone status. 51 Measurements 52 The primary endpoint was the stone expulsion rate. Secondary endpoints were time to stone 53 passage, the amount of analgesics required, the maximum daily pain-score, safety of the 54 therapy and the intervention rate. 55 Results and Limitations 56 Ten out of 100 randomised patients were excluded from the analysis. No statistically 57 significant differences were found between the two treatment arms in patient characteristics 58 and stone size (median 4.1mm (tamsulosin arm) vs. 3.8mm (placebo arm), p=0.3). The stone 59 expulsion rate was not significantly different between the tamsulosin arm (86.7%) and 60 placebo arm (88.9%; p=1.0). Median time to stone passage was 7 days in the tamsulosin arm 61 and 10 days in the placebo arm (logrank p=0.36). Patients in the tamsulosin arm required 62 significantly less analgesics than patients in the placebo arm (median 3 vs. 7 analgesics, 63