F Porpiglia1, P Destefanis, C Fiori, D Fontana. 1. Divisione Universitaria di Urologia, Dipartimento di Scienze Cliniche e Biologiche, Azienda Ospedaliera S. Luigi, Orbassano, Turin, Italy.
Abstract
OBJECTIVES: To evaluate the effectiveness of medical therapy during watchful waiting in patients with distal ureter stones. METHODS:Ninety-six patients with radiopaque stones located in the distal tract of the ureter and with stone sizes of 1 cm or smaller were involved in the study. The patients were randomly divided into two groups. Group A (n = 48) received oral treatment with 30 mg of deflazacort daily (maximum 10 days) plus 30 mg of slow-release nifedipine daily (maximum 4 weeks). Group B (n = 48) underwent a wait-and-watch approach. Both groups of patients were allowed to use diclofenac on demand. Statistical analyses were carried out using Student's t test, the chi-square test, and Fisher's exact test. RESULTS: The average stone size was 5.8 +/- 1.8 mm for group A and 5. 5 +/- 1.4 mm for group B. No statistically significant difference was found in stone size. Stone expulsion was observed in 38 (79%) of 48 patients in group A and in 17 (35%) of 48 patients in group B. The average expulsion time was 7 days (range 2 to 10) for group A and 20 days (range 10 to 28) for group B. A statistically significant difference was observed in both the expulsion rate and the expulsion time (P <0.05). The mean amount of sodium diclofenac used was 15 mg per patient for group A and 105 mg per patient for group B (P <0.05). CONCLUSIONS: The medical treatment proved to be effective and safe, as demonstrated by the increased stone expulsion rate, decreased expulsion time, and reduced need for analgesic therapy.
RCT Entities:
OBJECTIVES: To evaluate the effectiveness of medical therapy during watchful waiting in patients with distal ureter stones. METHODS: Ninety-six patients with radiopaque stones located in the distal tract of the ureter and with stone sizes of 1 cm or smaller were involved in the study. The patients were randomly divided into two groups. Group A (n = 48) received oral treatment with 30 mg of deflazacort daily (maximum 10 days) plus 30 mg of slow-release nifedipine daily (maximum 4 weeks). Group B (n = 48) underwent a wait-and-watch approach. Both groups of patients were allowed to use diclofenac on demand. Statistical analyses were carried out using Student's t test, the chi-square test, and Fisher's exact test. RESULTS: The average stone size was 5.8 +/- 1.8 mm for group A and 5. 5 +/- 1.4 mm for group B. No statistically significant difference was found in stone size. Stone expulsion was observed in 38 (79%) of 48 patients in group A and in 17 (35%) of 48 patients in group B. The average expulsion time was 7 days (range 2 to 10) for group A and 20 days (range 10 to 28) for group B. A statistically significant difference was observed in both the expulsion rate and the expulsion time (P <0.05). The mean amount of sodium diclofenac used was 15 mg per patient for group A and 105 mg per patient for group B (P <0.05). CONCLUSIONS: The medical treatment proved to be effective and safe, as demonstrated by the increased stone expulsion rate, decreased expulsion time, and reduced need for analgesic therapy.
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