BACKGROUND: Numerous randomised trials have confirmed the efficacy of medical expulsive therapy with tamsulosin in patients with distal ureteral stones; however, to date, no randomised, double-blind, placebo-controlled trials have been performed. OBJECTIVE: The objective of this trial was to evaluate the efficacy of medical expulsive therapy with tamsulosin in a randomised, double-blind, placebo-controlled setting. DESIGN, SETTING, AND PARTICIPANTS: Patients presenting with single distal ureteral stones < or = 7 mm were included in this trial. INTERVENTION: Patients were randomised in a double-blind fashion to receive either tamsulosin or placebo for 21 d. The medication was discontinued after either stone expulsion or intervention. Abdominal computed tomography was performed to assess the initial and final stone status. MEASUREMENTS AND LIMITATIONS: The primary end point was the stone expulsion rate. Secondary end points were time to stone passage, the amount of analgesic required, the maximum daily pain score, safety of the therapy, and the intervention rate. RESULTS:Ten of 100 randomised patients were excluded from the analysis. No statistically significant differences in patient characteristics and stone size (median: 4.1 mm [tamsulosin arm] vs 3.8 mm [placebo arm], p=0.3) were found between the two treatment arms. The stone expulsion rate was not significantly different between the tamsulosin arm (86.7%) and the placebo arm (88.9%; p=1.0). Median time to stone passage was 7 d in the tamsulosin arm and 10 d in the placebo arm (log-rank test, p=0.36). Patients in the tamsulosin arm required significantly fewer analgesics than patients in the placebo arm (median: 3 vs 7, p=0.011). A caveat is that the exact time of stone passage was missing for 29 patients. CONCLUSIONS:Tamsulosin treatment does not improve the stone expulsion rate in patients with distal ureteral stones < or = 7 mm. Nevertheless, patients may benefit from a supportive analgesic effect. CLINICALTRIALS.GOV: NCT00831701.
RCT Entities:
BACKGROUND: Numerous randomised trials have confirmed the efficacy of medical expulsive therapy with tamsulosin in patients with distal ureteral stones; however, to date, no randomised, double-blind, placebo-controlled trials have been performed. OBJECTIVE: The objective of this trial was to evaluate the efficacy of medical expulsive therapy with tamsulosin in a randomised, double-blind, placebo-controlled setting. DESIGN, SETTING, AND PARTICIPANTS: Patients presenting with single distal ureteral stones < or = 7 mm were included in this trial. INTERVENTION: Patients were randomised in a double-blind fashion to receive either tamsulosin or placebo for 21 d. The medication was discontinued after either stone expulsion or intervention. Abdominal computed tomography was performed to assess the initial and final stone status. MEASUREMENTS AND LIMITATIONS: The primary end point was the stone expulsion rate. Secondary end points were time to stone passage, the amount of analgesic required, the maximum daily pain score, safety of the therapy, and the intervention rate. RESULTS: Ten of 100 randomised patients were excluded from the analysis. No statistically significant differences in patient characteristics and stone size (median: 4.1 mm [tamsulosin arm] vs 3.8 mm [placebo arm], p=0.3) were found between the two treatment arms. The stone expulsion rate was not significantly different between the tamsulosin arm (86.7%) and the placebo arm (88.9%; p=1.0). Median time to stone passage was 7 d in the tamsulosin arm and 10 d in the placebo arm (log-rank test, p=0.36). Patients in the tamsulosin arm required significantly fewer analgesics than patients in the placebo arm (median: 3 vs 7, p=0.011). A caveat is that the exact time of stone passage was missing for 29 patients. CONCLUSIONS:Tamsulosin treatment does not improve the stone expulsion rate in patients with distal ureteral stones < or = 7 mm. Nevertheless, patients may benefit from a supportive analgesic effect. CLINICALTRIALS.GOV: NCT00831701.