Mirabegron beats tamsulosin at easing ureteral stent symptoms in randomized trial

Patients who need a ureteral stent often pay a hidden price for the device’s benefits: a cascade of lower urinary tract symptoms driven by inflammation of the bladder lining.

The trial, published in BMC Urology, enrolled patients undergoing unilateral ureteral stent placement and randomized them in equal proportions to one of three daily regimens: placebo, tamsulosin 0.4 mg, or mirabegron 50 mg.

Participants were assessed weekly with the Ureteral Stent Symptom Questionnaire (USSQ) to capture stent-related symptom severity. The researchers also took mucosal biopsies for histological grading of inflammation and measured serum and urinary concentrations of interleukin-6, an inflammatory cytokine, at baseline and again at week six. Statistical analysis used the Kruskal-Wallis test followed by Dunn’s post hoc test with Bonferroni correction.

Of the 60 subjects randomized, 50 completed the per-protocol analysis. In that analysis group, mirabegron showed clinical superiority over placebo in reducing USSQ scores, with a median difference of -15.0 points (95% confidence interval: -18.5 to -11.5; adjusted P < 0.001). That margin represents a substantial reduction in the symptom burden that stent carriers typically endure over the weeks the device remains in place.

The secondary outcomes reinforced the pattern. Compared with placebo, mirabegron significantly reduced histological inflammation grades, with a median difference of -1.5 (95% CI: -2.0 to -0.5; P = 0.001), and lowered serum IL-6 levels by a median of -1.72 pg/mL (95% CI: -2.45 to -0.98; P = 0.007). These findings link the symptomatic improvement to measurable changes in both tissue-level inflammation and a systemic inflammatory marker.

Tamsulosin, by contrast, showed intermediate efficacy. It did not significantly modulate IL-6 compared with placebo, suggesting that the alpha-blocker’s benefit on stent symptoms may not extend to the inflammatory processes the trial tracked. The head-to-head comparison therefore favors mirabegron on both the symptom and the biomarker endpoints.

Safety appeared favorable across the study: the authors report that no treatment-related adverse events occurred during the trial. The trial was registered at ClinicalTrials.gov (NCT06124066) on November 13, 2023, and the article was published as open access on October 27, 2026. The publisher notes that the version shared is an early, peer-reviewed accepted manuscript that remains citable and may be subject to further edits before the final Version of Record appears.

The authors conclude that mirabegron at 50 mg per day is more effective than tamsulosin at 0.4 mg per day in mitigating stent-induced lower urinary tract symptoms and systemic inflammatory markers, and they position it as a robust primary therapeutic option for managing stent-related morbidity.

Subject of Research: Comparative efficacy of mirabegron versus tamsulosin for ureteral stent-related symptoms and inflammation

Article Title: Comparative efficacy of mirabegron and tamsulosin in reducing bladder mucosal inflammation and IL-6 in patients with ureteral stents: a randomized double-blind clinical trial

Article References: Palinrungi, M. A., Rasyid, H., Prihantono, P., Cangara, M. H., Bukhari, A., Rahardjo, H. E., Syahrir, S., Zainuddin, A. A., & Faruk, M. (2026). Comparative efficacy of mirabegron and tamsulosin in reducing bladder mucosal inflammation and IL-6 in patients with ureteral stents: a randomized double-blind clinical trial. BMC Urology. https://doi.org/10.1186/s12894-026-02440-7

Image Credits: AI Generated

DOI: 10.1186/s12894-026-02440-7

Keywords: ureteral stent, mirabegron, tamsulosin, interleukin-6, lower urinary tract symptoms, bladder mucosal inflammation, randomized controlled trial, USSQ, urology, stent-related symptoms, Comparative, efficacy