Efficacy of Proflosin' in conservative management of ureteral stones

Abstract

Introduction: Medical expulsion therapy is a first - line for treatment of small ureteral calculi. Tamsulosin is the studied drug, but data received regarding its effectiveness are controversial and its administration is discussible. We aimed to assess the effect of tamsulosin as adjuvant therapy for ureteral calculi. Material and Methods: There were 64 patients examined with primary and recurrent ureterolithiasis. The presence of ureterolithiasis was assessed by ultrasound and/or radiological examination of upper urinary tract. Patients were analyzed for age, gender, stone size (>7 mm excluded) and location (side, upper, medium and lower 1/3 of ureter, kidney stones excluded), presence of UTI, chronic concomitant diseases. The patients were randomly divided into two groups - Group 1 -4 4 patients underwent the standard therapy with addition of Proflosin (Tamsulosin 0,4 mg) Berlin-Chemie/Menarini once a day, and 20 patients (Group II) - standard therapy only. Patients were offered a closely monitored trial for spontaneous stone passage in 4-week period prior to definitive therapy. The stone expulsion rate, VAS score and number of colic attacks, time of stone elimination and possible side effects of medication were observed. Results: All patients completed the study and none was excluded due to side effects. No significant differences were found between the groups for age, gender, stone size and location. Mean patient age was 45±6,8 years. There were 26 females and 38 males. The stone-free rate was 88,6% in Group I (39/44), compared with 70,0% (14/20) in Group II. Mean of colic attacks was 2,6±0,3 in Group I compared with 7,2±0,8 in Group II (p>0,001), and VAS score was 4 and 7 in Group I and II respectively. A mean stone expulsion time of 8,2 and 14,5 days was recorded for Group I and II respectively, and this difference was statistically significant (p<0,001). Conclusions: The adjunction of tamsulosin for conservative management of ureteral calculi decrease the time of stone expulsion, number of colic attacks and amount of analgesics. The Proflosin demonstrated no clinically significant adverse effects, while proving to be a safe and effective treatment option.