RANDOMIZED TRIAL OF THE SAFETY AND EFFICACY OF TAMSULOSIN AND SILODOSIN IN MEDICAL EXPULSIVE THERAPY FOR DISTAL THIRD URETERIC CALCULI

INTRODUCTION: Urolithiasis is a common condition that affects approximately 5% to 10% of the population and the incidence of Urolithiasis is rising. Ureteric stones account for 20% of urinary tract stones and about 70% of them are found in the lower third of the ureter at presentation. Recent literatures show the efficacy of various drugs and minimally invasive procedures for the management of lower third ureteral stones. We performed a randomized, prospective study to assess and compare the efficacy of tamsulosin and silodosin as medical expulsive therapy for lower third ureteral stones. SETTING AND DURATION: Department of Surgery, Hassan Institute of Medical Sciences/ Teaching Hospital, Hassan. from August 2013 to August 2014. MATERIALS AND METHODS: The prospective data of 60 symptomatic patients with unilateral, lower third ureteral calculi of less than ≤10 mm were randomly allocated for out- patient treatment with tamsulosin and silodosin groups Patients aged ≥ 18 years with a single, unilateral, symptomatic, radio-opaque ureteric stone of 10 mm or smaller in the largest dimension located between the lower border of the sacroiliac joint and vesico-ureteric junction were included. For Group I tamsulosin a daily single dose of 0.4 mg for 28days and for Group II a daily single dose of silodosin 8mg was given. Nonsteroidal anti-inflammatory drugs were used on demand for both the groups. All the patients were told to observe passage of stone by filtering urine stream. The primary end point was the expulsion of the stone and the secondary end points were expulsion time, analgesic use, socioeconomic status, need for hospitalization, endoscopic treatment and drug side effects were documented. RESULTS: The stone expulsion rates in patients treated with tamsulosin and silodosin were 83.3% and 86.6% respectively. Mean stone expulsion times in tamsulosin group and silodosin group were 6.8 and 6.2 days respectively. Mean number of pain episodes were 1.5 and 1.4 in the tamsulosin and silodosin group respectively. The mean number of analgesic requirement was 1.0 and 0.8 for the tamsulosin and silodosin group, respectively with no significant difference. Overall, incidence of side effects was similar in both groups. Patients taking silodosin experienced a higher incidence of retrograde ejaculation but a lower incidence of side effects related to peripheral vasodilation when compared to patients taking tamsulosin. Sub-group analysis shows, higher expulsion rates but lower mean expulsion time and pain episodes for stones ≤ 5 mm with both tamsulosin and silodosin groups. The total number of patients from lower socioeconomic status was more than 50% in this study and expulsion rates were better than with patients of higher socio-economic status with tamsulosin is 89 % and silodosin is 94%. There was higher expulsion rates in patients with stones ≤ 5 mm and this was true for both patients treated with tamsulosin 13(92.8%) and silodosin 14(93.3%). However the difference was not statistically significant. Most trials on MET for lower ureteric stones with tamsulosin demonstrated significant lower mean number of pain episodes with respect to placebo (1, 9, 21-23). Results from the present study in terms of mean number of pain episodes and need for