Efficacy and safety of silodosin, vardenafil versus silodosin in combination with vardenafil as a medical expulsive therapy for distal ureteric stones: a prospective randomized double-blind study

Abstract

BackgroundUrolithiasis is considered one of the most common diseases in urological practice. Its prevalence is about 1% to 15% with 30 years old as the peak age of incidence. Medical expulsive therapy (MET) has been used as a conservative treatment for patients with ureteral stones. Nitrergic fibers have been identified to have a relaxant effect on the distal ureteral smooth musculature. The objective of our study was to evaluate the efficacy and safety of the combination of silodosin and vardenafil as a medical expulsive therapy in comparison with each drug alone.MethodsOne hundred and two male patients with uncomplicated distal ureteric stone 6–10 mm were enrolled in the study. The patients were randomly divided into 3 equal groups, and each one consists of 34 patients. Group I received silodosin 8 mg once daily, group II vardenafil 5 mg once daily and group III combination of silodosin 8 mg and vardenafil 5 mg once daily. The treatment was given for all the patients until stone expulsion or a maximum of 4 weeks. The primary endpoint was the stone expulsion rate, and the secondary endpoints were time to stone expulsion, number of hospital visits for pain, amount of analgesic required and side effects associated with MET.ResultsOur study showed that the stone expulsion rate was higher in combination = 90.0% than silodosin = 76.7% and vardenafil groups = 60.0% (P = 0.025), the time to stone expulsion was significantly shorter in combination = 11.23 ± 3.14 than silodosin = 12.50 ± 1.66 and vardenafil groups 14.67 ± 1.24 days (P < 0.01), the number of hospital visits for pain was statistically significant between the three groups (silodosin 1.35 ± 0.9, vardenafil 1.65 ± 1.09 and combination groups 1.02 ± 0.80) (P = 0.038) and lesser amount of analgesic required in combination 313.6 ± 2.85.5 than silodosin 613.44 ± 483.62 and vardenafil groups 716.97 ± 685.3 (P = 0.008). There was no significant difference among the studied groups as regards the drugs side effects except for retrograde ejaculation (silodosin and combination = 86.7% vs vardenafil groups = 0.0%) (P < 0.05) and increased erection (combination = 26.7%, vardenafil = 23.3% and silodosin groups = 0%) (P = 0.010).ConclusionThe prescription of vardenafil in combination with silodosin is safe and more effective than silodosin or vardenafil alone as a MET.