STONE DISEASE

Medical-expulsive therapy for distal ureterolithiasis: randomized prospective study on role of corticosteroids used in combination with tamsulosin-simplified treatment regimen and health-related quality of life
Dellabella M, Milanese G, Muzzonigro G
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
Urology. 2005; 66: 712-5

• 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.
  
  
• Editorial Comment
  One of the most significant advances in stone management that has come about in the last few years is the use of pharmacotherapy to facilitate spontaneous passage of ureteral calculi. A number of well-designed, prospective, randomized trials demonstrated the efficacy of calcium channel blockers and tamsulosin, in conjunction with corticosteroids, in promoting stone passage and reducing the pain associated with it. With comparable efficacy demonstrated for nifedipine and tamsulosin, the reduced side-effect profile of tamsulosin has made it the drug of choice in treating patients with ureteral calculi. However, prior trials included corticosteroids along with tamsulosin or nifedipine, although many practitioners simply skipped this component of the pharmacologic regimen for fear of steroid-related complications such as ulcer disease. Dellabella and colleagues performed a head-to-head comparison of tamsulosin with or without corticosteroids for the management of patients with > 4 mm distal ureteral calculi. Although spontaneous passage rates (90% versus 97%, respectively), ER/admission rates, and pain medication requirements were comparable between the 2 groups, the group receiving corticosteroids passed their stones an average of 2 days sooner. Consequently, the addition of corticosteroids results in quicker stone passage, but the benefit of improved stone passage rates and reduced need for pain medication are still obtained with tamsulosin alone. Thus, for patients without a contraindication to corticosteroids, the use of both tamsulosin and prednisone provides optimal therapy. However, tamsulosin alone is effective and even in patients in whom corticosteroids are best avoided.

Dr. Margaret S. Pearle
Associate Professor of Urology
University of Texas Southwestern Med Ctr
Dallas, Texas, USA