The use of tamsulozin as adjunctive treatment after ESWL in patients with distal ureteral stone: do we really need it? Results from a randomised study.

Our study aimed to define the position of tamsulosin as adjunctive therapy in patients with stones of the distal ureter who had undergone extracorporeal shock wave lithotripsy (ESWL). In total, 61 consecutive patients (38 men and 23 women) with single distal radiopaque ureteral stone of > or =6 mm of diameter were enrolled. After ESWL patients were randomized in two groups. Non-steroidal anti-inflammatory drug (supp. diclofenac 50 mg) was given to both groups upon demand. In group B, all patients (30) received additionally tamsulozin 0.4 mg every day. Follow-up visits were performed 1, 2, 3 and 4 weeks after ESWL. Evaluation included a KUB plain film and an ultrasound examination. Efficacy was evaluated in terms of success rate, stone-free rate, expulsion time of the fragments and use of diclofenac. Two patients from the tamsulosin group experienced dizziness and one was withdrawn. The success rate was 58.06 and 66.66% for the control and the tamsulosin group, respectively, while the corresponding values for stone-free rate were 51.6 and 63.33%, respectively. The mean expulsion time of the fragments was 13.22 days for group A and 12.95 days for group B. These results did not achieve statistically significant difference (P > 0.05). The mean diclofenac dose was 118.9 mg in group A and 56.9 mg in group B. This difference was statistically significant (P = 0.02). Despite the relatively small number of patients, our data indicate that the use of tamsulosin after ESWL in this specific subgroup of patients does not result in improved success and stone-free rate and expulsion time. In contrast, a significantly reduced need for analgesics was found.

RCT Entities:   Population Interventions Outcomes