Marco Dellabella1, Giulio Milanese, Giovanni Muzzonigro. 1. Department 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. d.urologia@ao-umbertoprimo.marche.it
Abstract
OBJECTIVES: To assess the clinical efficacy of the addition of a corticosteroid drug to tamsulosin in the medical-expulsive therapy of distal ureterolithiasis. METHODS:Sixty consecutive patients with a symptomatic distal ureteral stone were included in our study and randomized to one of two home treatment groups. Group 1 patients (n = 30) received tamsulosin (0.4 mg daily), and group 2 patients (n = 30) were treated with a corticosteroid drug (deflazacort, 30 mg daily) plus tamsulosin. The treatment duration was until stone expulsion or 28 days, whichever came first. The primary endpoint of the study was the stone expulsion rate. The secondary endpoints were the expulsion time; use of analgesics; number of emergency room admissions, hospitalizations, and workdays lost; drug side effects; and quality of life of the patients (EuroQol questionnaire, EQ-5D) during treatment. RESULTS: The two groups had a similar expulsion rate (90% for group 1 and 96.7% for group 2; P = 0.612), but the expulsion time was significantly reduced in group 2 patients (P = 0.036). During the treatment period, we did not observe significant differences between the two groups in the number of emergency room visits or hospitalizations, analgesic use, number of workdays lost, or incidence of drug side effects. The quality of life of the patients during therapy, as determined using the EQ-5D, was similar in both groups. CONCLUSIONS: The use of a corticosteroid drug in association with tamsulosin seemed to induce more rapid stone expulsion. In addition, tamsulosin alone as medical-expulsive therapy for distal ureteral calculi had excellent expulsive effectiveness.
RCT Entities:
OBJECTIVES: To assess the clinical efficacy of the addition of a corticosteroid drug to tamsulosin in the medical-expulsive therapy of distal ureterolithiasis. METHODS: Sixty consecutive patients with a symptomatic distal ureteral stone were included in our study and randomized to one of two home treatment groups. Group 1 patients (n = 30) received tamsulosin (0.4 mg daily), and group 2 patients (n = 30) were treated with a corticosteroid drug (deflazacort, 30 mg daily) plus tamsulosin. The treatment duration was until stone expulsion or 28 days, whichever came first. The primary endpoint of the study was the stone expulsion rate. The secondary endpoints were the expulsion time; use of analgesics; number of emergency room admissions, hospitalizations, and workdays lost; drug side effects; and quality of life of the patients (EuroQol questionnaire, EQ-5D) during treatment. RESULTS: The two groups had a similar expulsion rate (90% for group 1 and 96.7% for group 2; P = 0.612), but the expulsion time was significantly reduced in group 2 patients (P = 0.036). During the treatment period, we did not observe significant differences between the two groups in the number of emergency room visits or hospitalizations, analgesic use, number of workdays lost, or incidence of drug side effects. The quality of life of the patients during therapy, as determined using the EQ-5D, was similar in both groups. CONCLUSIONS: The use of a corticosteroid drug in association with tamsulosin seemed to induce more rapid stone expulsion. In addition, tamsulosin alone as medical-expulsive therapy for distal ureteral calculi had excellent expulsive effectiveness.
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