Efficacy of the combination of tadalafil and tamsulosin versus tadalafil alone as a medical expulsive therapy for stone L1/3 ureter 10 mm or less: A prospective comparative placebo-controlled study.

Background: The lifetime occurrence of urinary stones is approximately 1%-15%, and the peak age of occurrence is 30 years. Approximately one fifths of urinary tract stones are found in the ureter, of which two thirds are in the distal ureter. Many drugs, including phosphodiesterase-5 inhibitors (PDE5Is) and α-blockers, are used to relax the smooth muscles in medical expulsive therapy (MET). We aimed to compare the combination of tadalafil and tamsulosin versus tadalafil alone as MET for stones in the L1/3 ureter of 10 mm or less.

Materials and methods: A total of 150 patients with L1/3 ureteric stones measuring 10 mm or less were enrolled in the study and randomly assigned to one of 3 equal groups using a computer-generated random number. Patients in group A prescribed tadalafil 10 mg/d. However, those in group B were prescribed tamsulosin 0.4 mg and tadalafil 10 mg/d, whereas those in group C received a placebo once daily. Stone expulsion rate and pain recurrence were evaluated after 14 days.

Results: The stone expulsion rate was significantly higher in the tadalafil and tamsulosin groups and the tamsulosin group than in the placebo group in the current study by 68% in the combination group, 64% in the tadalafil alone group, and 42% in the placebo group (p = 0.019). In the current study, a combination was associated with lower pain recurrence than tadalafil alone or placebo, with means of 1.06, 1.9, 2.98 (with a p value of 0.001). Stone size was not effective in any group.

Conclusions: The combination of PDE5Is and α-blockers effectively increases the expulsion of lower ureteric stones (5-10 mm), but with the same effect as PDE5Is alone, with the advantage of decreasing pain recurrence. Stone size did not affect the expulsion rate in patients who received MET for stones less than 1 cm in size.