Expulsive therapy: Two-drug combination found best

June 1, 2006

Paris-Administration of corticosteroid therapy does not significantly increase the expulsion rate of distal ureteral stones. However, the synergistic effect of steroid therapy with concomitant administration of the alpha-blocker tamsulosin (Flomax) increases the effectiveness of tamsulosin, Italian researchers reported at the recent European Association of Urology annual congress here.

Paris-Administration of corticosteroid therapy does not significantly increase the expulsion rate of distal ureteral stones. However, the synergistic effect of steroid therapy with concomitant administration of the alpha-blocker tamsulosin (Flomax) increases the effectiveness of tamsulosin, Italian researchers reported at the recent European Association of Urology annual congress here.

"When medical expulsive therapy is considered for non-complicated, yet symptomatic distal ureteral stones, the use of steroids like deflazacort proves to be efficient only when administered together with an alpha-1 blocker like tamsulosin," said Francesco Porpiglia MD, associate professor of urology, University of Medicine and Surgery, Torino, Italy. "Furthermore, tamsulosin can be administered as a single agent, is efficient in achieving stone expulsion, and can be considered as an alternative treatment in those patients who are not suitable for steroid therapy."

Dr. Porpiglia and his team of researchers conducted a prospective study of 114 patients who had distal ureteral stones evidenced by ultrasound or radiograph and managed with watchful waiting. Stone sizes ranged from 5.71 mm to 5.96 mm. The ultimate goal of the study was to measure and evaluate the effects of corticosteroid therapy on distal ureteral stones.

Study endpoints were expulsion rate, analgesic consumption, safety and number of ureteroscopies in groups A, B, and C, which were match-controlled with group D.

Patients were treated for 10 days to prevent any side effects from prolonged corticosteroid therapy. They were instructed to drink 2 liters of water daily and, if pain levels were too great, they received intramuscular sodium diclofenac (Arthrotec).

The expulsion rate for the study was 60% in group A (18 of 30 patients), 37.5% in group B (9 of 24), 84.8% in group C (28 of 30), and 33.3% in group D (8 of 24). Three patients from group A left the study before treatment was concluded.

Dr. Porpiglia noted that a statistically significant difference was observed in patients who received both tamsulosin and corticosteroid therapy (group C) compared with patients in groups A, B, and D. In addition, a moderate statistical difference was seen in group A (tamsulosin monotherapy) compared with those in the control group.

Non-responding patients with evidence of lithiasis underwent ureteroscopy.

Dr. Porpiglia noted very few side effects: two cases of hypotension and three cases of lipothymia in group A. For groups A, B, C, and D, respectively, the median amount of sodium diclofenac administered to patients was 42.5 mg, 50 mg, 27.3 mg, and 81 mg.

Anup Patel, MD, consulting urologist on the faculty, Imperial School of Medicine, St. Mary's Hospital, London, England, asked whether the patients were standardized for a degree of hydronephrosis when they presented with their stones.

"In the cases where hydronephrosis arises, the stones are symptomatic, and we do not advise this therapy," Dr. Porpiglia responded. "We like to start the patient on an antibiotic therapy and, possibly, follow up with the insertion of a nephrostomy tube, or even the insertion of a ureteric stent, bypassing the obstruction."