The use of tamsulosin in the treatment of 10–15 mm lower ureteral stones in adults: a double-blinded randomized controlled trial

Abstract
Background
The discovery of alpha-adrenergic receptors in the ureteral smooth muscle cells led to a thorough investigation of the therapeutic potential of alpha-blockers for ureteral calculi. Tamsulosin is a selective blocker of alpha-1A and alpha-1B adrenoceptors. It significantly improved the expulsion of distal ureteral stones measuring 3–10 mm in most randomized trials. To the best of our knowledge, tamsulosin was not tested before in the management of ureteral stones 10–15 mm. Hence, the present study aimed at estimation of the efficacy of tamsulosin in the expulsion of lower ureteral stones 10–15 mm in length compared to placebo in adult patients (primary goal) and the need for ureteral dilatation at scheduled ureteroscopy.

Methods
Between November 2017 and November 2019, 80 patients with distal ureteral stones 10–15 mm were divided into two equal groups. One group received tamsulosin 0.4 mg/day and the other received a placebo. Patients were followed-up for 8 weeks.

Results
Six patients of the tamsulosin group (15%) passed their stones spontaneously compared to none of the placebo group (p = 0.026). Two of the 6 patients who passed the ureteral stones developed urinary retention and required endoscopic treatment of urethral stones. So, the adjusted spontaneous ureteral stone passage ratios for the tamsulosin and the control groups were 10 and 0%, respectively (p = 0.12). Overall, 37.5% reported adverse effects in the tamsulosin group, and 30% in the placebo group (p = 0.7). The most common adverse effect reported in both groups was dizziness, which occurred more frequently with tamsulosin (25%) than placebo (22.5%) (p = 0.9). We noticed increased ejaculatory dysfunction among men in the tamsulosin group versus placebo group [17.9% vs. 3.5% (p = 0.1)]. Among patients who needed ureteroscopy, ureteral dilatation was always needed in the control group versus 85.3% of the tamsulosin group (p = 0.015). Although 23.5% of the treatment group didn’t need stents after ureteroscopy compared to only 12.5% of the control group, this difference was not statistically significant (p = 0.2).

Conclusions
Although tamsulosin significantly increased spontaneous passage of 10–15 mm lower ureteral stones in adults, it did not decrease the need for operative intervention. Preoperative tamsulosin significantly facilitated ureteral dilations during ureteroscopic management.