Comparative study between silodosin, tamsulosin, silodosin plus tadalafil, and tamsulosin plus tadalafil as a medical expulsive therapy for lower ureteral stones: a prospective randomized trial.

Abstract

Purpose: To examine the safety and efficiency of a single-drug therapy with silodosin or tamsulosin versus combined therapy with silodosin plus tadalafil and tamsulosin plus tadalafil as a medical expulsive therapy (MET) for lower ureteral stones.

Methods: This research was a prospective randomized clinical trial carried out at Fayoum University Hospital, Egypt, over one year. Patients with lower ureteral stones (5-10 mm) were randomly allocated into one of four treatment groups. Group A received silodosin 8 mg per day; Group B received tamsulosin 0.4 mg per day; Group C received silodosin 8 mg plus tadalafil 5 mg daily, and Group D received tamsulosin 0.4 mg plus tadalafil 5 mg daily. Treatment was prescribed for up to 4 weeks. The study outcomes were the stone expulsion rate, stone expulsion time, the amount of analgesics used, the frequency of pain episodes, hospital visits, and any treatment-related adverse effects.

Results: One hundred eighty patients who fulfilled the inclusion criteria completed the study. Group C had a significantly elevated stone expulsion rate (91.1%) compared to Group A (57.8%) and Group B (71.1%) [P = 0.015, P < 0.001, respectively]. Group D had a significantly elevated stone expulsion rate (86.7%) compared to Group B (57.8%) [P = 0.002] and higher than Group A (71.1%). Group C and Group D had significantly less stone expulsion time, analgesic needs, and episodes of renal colic, and fewer hospital visits than Group A and Group B. No significant differences were found in adverse effects like orthostatic hypotension, dizziness, backache, headache, myalgia, and nausea between the patient groups.

Conclusion: Combining silodosin with tadalafil and tamsulosin with tadalafil was more efficient as MET for lower ureteric stones than a single treatment with silodosin or tamsulosin.