PURPOSE: We evaluated the efficacy of alfuzosin as medical expulsive therapy for distal ureteral stone passage. MATERIALS AND METHODS: A total of 76 patients with a distal ureteral calculus provided consent for the study. Patients were randomized between placebo and study medication, and investigators and patients were blinded to the randomization scheme. Followup was done on a weekly basis and continued until the patient was rendered stone-free. The patient blood pressure, discomfort level, stone position on imaging, number of remaining pills and any adverse events were assessed. Statistical analysis was performed with the Student t test with p <0.05 considered significant. RESULTS: The overall spontaneous stone passage rate was 75%, including 77.1% for placebo and 73.5% for alfuzosin (p = 0.83). Mean +/- SD time needed to pass the stone was 8.54 +/- 6.99 days for placebo vs 5.19 +/- 4.82 days for alfuzosin. (p = 0.003). There was no difference in the size or volume of stones that passed spontaneously between the placebo and alfuzosin arms, as measured on baseline computerized tomography (4.08 +/- 1.17 and 3.83 +/- 0.95 mm, p = 0.46) and by a digital caliper after stone expulsion (3.86 +/- 1.76 and 3.91 +/- 1.06 mm, respectively, p = 0.57). When comparing the improvement from the baseline pain score, the alfuzosin arm experienced a greater decrease in pain score in the days after the initial emergency department visit to the date of stone passage (p = 0.0005). CONCLUSIONS:Alfuzosin improves the patient discomfort associated with stone passage and decreases the time to distal ureteral stone passage but it does not increase the rate of spontaneous stone passage.
RCT Entities:
PURPOSE: We evaluated the efficacy of alfuzosin as medical expulsive therapy for distal ureteral stone passage. MATERIALS AND METHODS: A total of 76 patients with a distal ureteral calculus provided consent for the study. Patients were randomized between placebo and study medication, and investigators and patients were blinded to the randomization scheme. Followup was done on a weekly basis and continued until the patient was rendered stone-free. The patient blood pressure, discomfort level, stone position on imaging, number of remaining pills and any adverse events were assessed. Statistical analysis was performed with the Student t test with p <0.05 considered significant. RESULTS: The overall spontaneous stone passage rate was 75%, including 77.1% for placebo and 73.5% for alfuzosin (p = 0.83). Mean +/- SD time needed to pass the stone was 8.54 +/- 6.99 days for placebo vs 5.19 +/- 4.82 days for alfuzosin. (p = 0.003). There was no difference in the size or volume of stones that passed spontaneously between the placebo and alfuzosin arms, as measured on baseline computerized tomography (4.08 +/- 1.17 and 3.83 +/- 0.95 mm, p = 0.46) and by a digital caliper after stone expulsion (3.86 +/- 1.76 and 3.91 +/- 1.06 mm, respectively, p = 0.57). When comparing the improvement from the baseline pain score, the alfuzosin arm experienced a greater decrease in pain score in the days after the initial emergency department visit to the date of stone passage (p = 0.0005). CONCLUSIONS:Alfuzosin improves the patient discomfort associated with stone passage and decreases the time to distal ureteral stone passage but it does not increase the rate of spontaneous stone passage.
Authors: Vassilios Tzortzis; Charalampos Mamoulakis; Jorge Rioja; Stavros Gravas; Martin C Michel; Jean J M C H de la Rosette Journal: Drugs Date: 2009 Impact factor: 9.546