Efficacy and Safety of Silodosin, Prednisolone or Both for Spontaneous Passage of Lower UretericStones and Renal Colic Control

Introduction and objectives: Medical expulsive therapy has now become an established modality of treatment for lower ureteric stones and it involves using of different drugs that act on ureter by different mechanisms. Medical expulsive therapy has a proven role to promote stone passage and reduce the need for minimally invasive surgery. Our aim is to compare the safety and efficacy of Silodosin alone, Silodosin with Prednisolone and Prednisolone alone as medical expulsive therapy for distal ureteric stones. Methods: Between January 2016 and September 2016, 150 adult patients presenting with distal ureteric stones of size 5 mm to 20 mm were randomized equally to Silodosin with Prednisolone (group A) ,Silodosin only (group B) and Prednisolone only(group C). Each one was given for a maximum of two weeks. In the group A and group C, 5 mg of Prednisolone was given once daily. Stone expulsion rate, time to stone expulsion, analgesic use, follow-up and endoscopic treatment and adverse effects of drugs were noted. Statistical analyses were done using chi squaretest, and analysis of variance. Results: Stone size has high statistical significance with stone passage, time of expulsion and analgesic requirement between group A and both group B and group C (p-value < 0.001). The mean to expulsion and analgesic use were significantly lower in group A than group B (p value < 0.001), it was statistically significant with group A and C with (p value > 0.001). Regarding stone size: Stone size > 10 mm: 83% (66% passed stone [ A: 26.5% , B:30.5%, C:9%] )+ 17% not passed [ A:2.5%, B:3%, C:11.5%]), Stone size < 10 mm: 17% (5% passed stone [ A: 5% , B:0%, C:0%] )+ 12% not passed [ A:2%, B:3%, C:7%]), The expulsion rates were not statistically different between groups A, B and C.Regarding to the side effects: In group A: 3 patients had gastritis which started after 5 days or more from beginning of the treatment and resolved completely without any additional treatment in a period less than 2 weeks. Only 1 patient had increase in blood glucose level reaching 180 mg/dl and returned to the baseline 110 mg/dl after 10 days of discontinuation of the treatment, 3 patients had increase blood pressure readings starting after 5 days or more from beginning of the treatment, not exceeding 150/90 mmHg rising from baseline 120/80 mmHg and returned back to baseline in a period less than 10 days after discontinuation of the drug, In group C: 3 patients had gastritis, 1 patient had increase blood pressure, 1 patient had increase in blood glucose level. The most frequent adverse event with Silodosin group was a reduced or absent ejaculation, In group A: 18 patients (8 patients were distressed, 4 patients were not distressed and 6 patients were distressed but can wait for its improvement) and in group B: 19 patients (10 patients were distressed, 4 patients were not distressed and 5 patients were distressed but can wait for its improvement). Conclusions: Medical expulsive therapy for the distal ureteric stones using either Silodosin or Silodosin in combination with Prednisolone is safe and efficacious with faster more pain controlling.