Nouran O El Said1, Lamia El Wakeel2, Khaled M Kamal3, Abd El Reheem Morad4. 1. Department of Pharmacy Practice and Clinical Pharmacy, Faculty of Pharmacy, Future University, Cairo, Egypt. 2. Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt. 3. Department of Urology, Faculty of Medicine, Ain Shams University, Cairo, Egypt. 4. Department of Clinical Pharmacy, Faculty of Pharmacy, Misr University for Science & Technology, Cairo, Egypt.
Abstract
OBJECTIVE: To evaluate the safety and efficacy of alfuzosin treatment on rate and time of stone expulsion in patients with uncomplicated distal ureteral stones. PATIENTS AND METHODS: Prospective, randomized, open-label, controlled study. Patients > 18 years of age presenting to the outpatient urology clinic with uncomplicated radio-opaque stones located in the distal third of the ureter and of size ≤ 10 mm were included. Patients were randomly assigned to either a control group (n=26) and received standard of care management (daily oral hydration and diclofenac 75 mg IM on demand) or to the alfuzosin group (n=28) and received alfuzosin SR 5 mg twice daily in addition to standard of care management. Patients were followed weekly at office visits and twice weekly by telephone for 4 weeks or until stone expulsion. Assessments included stone passage rate and time, and patients were monitored for occurrence of adverse drug events, complications, number of pain episodes, analgesic consumption, and number of hospital revisits. Mann-Whitney, χ(2) , and Fisher exact test were used for data analysis. RESULTS:All 54 patients completed the study. Stone expulsion rate was higher in the alfuzosin arm (53.6%, 15/28) compared to the control arm (26.9%, 7/26, p=0.04). Median stone passage time was lower in the alfuzosin group than in the control group (9 vs 19 days, respectively, p=0.006). Ureteral sepsis, uncontrollable pain, and hospitalization readmissions were reported in the control group only. There were no differences between groups in number of pain episodes, pain scores, or analgesic consumption. Alfuzosin therapy was tolerable with only minor adverse effects (headache, dizziness, mild postural hypotension, and rhinitis). CONCLUSION:Alfuzosin is safe and effective in increasing stone expulsion rates and shortening stone passage times for uncomplicated distal ureteral stones.
RCT Entities:
OBJECTIVE: To evaluate the safety and efficacy of alfuzosin treatment on rate and time of stone expulsion in patients with uncomplicated distal ureteral stones. PATIENTS AND METHODS: Prospective, randomized, open-label, controlled study. Patients > 18 years of age presenting to the outpatient urology clinic with uncomplicated radio-opaque stones located in the distal third of the ureter and of size ≤ 10 mm were included. Patients were randomly assigned to either a control group (n=26) and received standard of care management (daily oral hydration and diclofenac 75 mg IM on demand) or to the alfuzosin group (n=28) and received alfuzosin SR 5 mg twice daily in addition to standard of care management. Patients were followed weekly at office visits and twice weekly by telephone for 4 weeks or until stone expulsion. Assessments included stone passage rate and time, and patients were monitored for occurrence of adverse drug events, complications, number of pain episodes, analgesic consumption, and number of hospital revisits. Mann-Whitney, χ(2) , and Fisher exact test were used for data analysis. RESULTS: All 54 patients completed the study. Stone expulsion rate was higher in the alfuzosin arm (53.6%, 15/28) compared to the control arm (26.9%, 7/26, p=0.04). Median stone passage time was lower in the alfuzosin group than in the control group (9 vs 19 days, respectively, p=0.006). Ureteral sepsis, uncontrollable pain, and hospitalization readmissions were reported in the control group only. There were no differences between groups in number of pain episodes, pain scores, or analgesic consumption. Alfuzosin therapy was tolerable with only minor adverse effects (headache, dizziness, mild postural hypotension, and rhinitis). CONCLUSION:Alfuzosin is safe and effective in increasing stone expulsion rates and shortening stone passage times for uncomplicated distal ureteral stones.
Authors: John M Hollingsworth; Benjamin K Canales; Mary A M Rogers; Shyam Sukumar; Phyllis Yan; Gretchen M Kuntz; Philipp Dahm Journal: BMJ Date: 2016-12-01