Effectiveness of Solifenacin Monotherapy and Mirabegron and Solifenacin Combination Therapy in Patients with Stent-Related Symptoms

Abstract

INTRODUCTION: Ureteral stents are commonly used for internal urinary drainage but frequently cause stent-related symptoms (USRSs), which can negatively affect patient quality of life. This study aimed to evaluate the short-term effectiveness of solifenacin monotherapy compared to a solifenacin-mirabegron combination therapy in patients experiencing USRSs. MATERIALS AND METHODS: This double-blind, randomised controlled trial included 54 participants with USRSs. Patients were randomised to receive either solifenacin 5 mg/day (monotherapy) or a combination of solifenacin 5 mg/day and mirabegron 25 mg/day (combination therapy) for four weeks. The Ureteral Stent Symptom Questionnaire (USSQ) was used to compare treatment outcomes. Data were analysed using an independent t-test, with p-values <0.05 considered statistically significant. RESULTS: The solifenacin monotherapy group showed significantly lower (better) scores in the Urinary Symptoms domain compared to the combination group at week 1 (p=0.001) and week 2 (p=0.017), and in the General Health domain at week 1 (p=0.005), week 2 (p=0.027), and week 4 (p=0.045). The combination therapy group demonstrated significantly better scores for Sexual Function at week 2 (p=0.017). No statistically significant differences were observed between groups for Pain or Work domains. Both treatments were generally well-tolerated, with a low incidence of mild adverse events. CONCLUSIONS: Solifenacin monotherapy appears to provide superior short-term relief for urinary symptoms and general health issues compared to a low-dose solifenacin-mirabegron combination. The combination therapy demonstrated a targeted benefit in improving sexual function. Both treatment regimens were generally safe and well-tolerated.