Marco Dellabella1, Giulio Milanese, Giovanni Muzzonigro. 1. Department of Urology and Division of Urology, Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I.-G. M. Lancisi-G. Salesi, Polytechnic University of the Marche Region, School of Medicine, Ancona, Italy.
Abstract
PURPOSE: Recent studies show the interesting efficacy of different drug combinations for the spontaneous expulsion of distal ureteral stones. We performed a randomized, prospective study to assess and compare the efficacy of 3 drugs as medical expulsive therapy for distal ureteral calculi. MATERIALS AND METHODS: A total of 210 symptomatic patients with distal ureteral calculi greater than 4 mm were randomly allocated to home treatment with phloroglucinol, tamsulosin or nifedipine (groups 1 to 3, respectively). Each group was given a corticosteroid drug and antibiotic prophylaxis with an injectable nonsteroidal anti-inflammatory drug was also used on demand. The primary end point was the expulsion rate and the secondary end points were expulsion time, analgesic use, need for hospitalization and endoscopic treatment as well as the number of workdays lost, quality of life and drug side effects RESULTS: The expulsion rate was significantly higher in group 2 (97.1%) than in groups 1 (64.3%, p <0.0001) or 3 (77.1%, p <0.0001). Group 2 significantly achieved stone passage in a shorter time than the other 2 groups and showed a significantly decreased number of hospitalizations as well as a better decrease in endoscopic procedures performed to remove the stone. The control of renal colic pain was significantly superior in group 2 compared with the other groups, resulting in fewer workdays lost. Group 3 showed lower analgesic use and decreased workdays lost compared with group 1. No difference in side effects was observed among the groups. CONCLUSIONS: Medical expulsive therapy should be considered for distal ureterolithiasis without complications before ureteroscopy or extracorporeal lithotripsy. The use of tamsulosin in this treatment regimen produced stone expulsion in almost all cases in a short time, allowing complete home patient treatment.
RCT Entities:
PURPOSE: Recent studies show the interesting efficacy of different drug combinations for the spontaneous expulsion of distal ureteral stones. We performed a randomized, prospective study to assess and compare the efficacy of 3 drugs as medical expulsive therapy for distal ureteral calculi. MATERIALS AND METHODS: A total of 210 symptomatic patients with distal ureteral calculi greater than 4 mm were randomly allocated to home treatment with phloroglucinol, tamsulosin or nifedipine (groups 1 to 3, respectively). Each group was given a corticosteroid drug and antibiotic prophylaxis with an injectable nonsteroidal anti-inflammatory drug was also used on demand. The primary end point was the expulsion rate and the secondary end points were expulsion time, analgesic use, need for hospitalization and endoscopic treatment as well as the number of workdays lost, quality of life and drug side effects RESULTS: The expulsion rate was significantly higher in group 2 (97.1%) than in groups 1 (64.3%, p <0.0001) or 3 (77.1%, p <0.0001). Group 2 significantly achieved stone passage in a shorter time than the other 2 groups and showed a significantly decreased number of hospitalizations as well as a better decrease in endoscopic procedures performed to remove the stone. The control of renal colic pain was significantly superior in group 2 compared with the other groups, resulting in fewer workdays lost. Group 3 showed lower analgesic use and decreased workdays lost compared with group 1. No difference in side effects was observed among the groups. CONCLUSIONS: Medical expulsive therapy should be considered for distal ureterolithiasis without complications before ureteroscopy or extracorporeal lithotripsy. The use of tamsulosin in this treatment regimen produced stone expulsion in almost all cases in a short time, allowing complete home patient treatment.
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