Introduction and Objectives
To conduct a randomized trial and determine the role of Omnic Tocas (Tamsulosin hydrochloride) as adjuvant therapy for the extracorporeal shockwave lithotripsy (ESWL) of kidney and ureter stones.
Material and Methods
From 02.2006 to 04.2007 were included 248 patients, of them 186 completed a full survey and were treated statistically, of them 121 were men and 65 women at mean age 52±21 d. 77 ureter stones with medium size 9±4 millimeters and 109 kidney stones with average size 13±7 millimeters were lithotripted. Patients were randomized into two groups: Group A – patients treated with standard medications after ESWL: antibiotic, Prednisolon − 20 mg / 24 h for ten days and Diclofenac sodium in case of severe pain. Group B – patients received medication from Group A, but also Tamsulosin − 0.4 md / 24 h was added for one month. All patients were followed for 4, 8, 12 weeks by KUB plain film combined with ultrasonography. The main values by which were compared the two groups were: ESWL efficiency, frequency of renal colic, time needed for elimination of the fragments, frequency of rehospitalisations, side effects.
In the group of patients taking Tamsulosin, there was significantly better and faster elimination rate of stone fragments, that's why only for the first month 73.4% of them practically completely eliminated the stone fragments, while the group of patients receiving only corticosteroids, the value reaching only 55.9% and p < 0001. Only 6.8 percent of patients taking Tamsulosin, needed rehospitalisations unlike the other group of which 21.7% – p < 0001 were rehospitalised. In the group taking Tamsulosin renal colic was observed in 24.6% of the patients, opposed to the group receiving only corticosteroids – 68.4% – p < 0.05. We have not observed side effects leading to discontinuation of the treatment.
From the conducted comparative analysis of the different parameters in the two randomized groups clearly show out the benefits of adjuvant drug therapy after ESWL, where patients besides standard treatment with corticosteroids and analgesics additionaly take Tamsulosin.
© 2009 European Association of Urology. Published by Elsevier Inc. All rights reserved.