Combination treatment of mirabegron and solifenacin versus solifenacin monotherapy in female patients with overactive bladder - A comparative study on effectiveness, safety, symptoms and quality of life and treatment adherence.

Purpose: Compared to other overactive bladder (OAB) symptoms, incontinence has a more negative impact on quality of life and is frequently challenging to treat with antimuscarinic monotherapy. This study's goal was to compare the safety, tolerability, and effectiveness of a combination of solifenacin 5 mg and mirabegron 25 mg or 50 mg versus solifenacin 5 mg in patients with OAB.

Material and methods: In a tertiary care hospital, 258 individuals with overactive bladders participated in a randomised controlled open-label research to examine the safety and efficacy of mirabegron as a supplement to solifenacin. Randomisation was used to assign patients to one of three groups: those receiving solifenacin (5 mg) with mirabegron (25 mg), solifenacin (5 mg) plus mirabegron (50 mg) or solifenacin (5 mg) monotherapy. OABSS was used to examine the patients. A change in the OABSS from baseline to end of treatment (EOT) was the main outcome measure. This research also examined the safety and tolerability of combination treatment in comparison to solifenacin monotherapy.

Results: All combinations with solifenacin five substantially improved the OAB symptoms score as compared to solifenacin 5 mg monotherapy. When compared to solifenacin 5 mg, both combination groups significantly decreased the frequency of micturition. Although there were no dose-related differences between the combination and monotherapy groups in terms of TEAEs, blood pressure, pulse rate, PVR volume, or laboratory or ECG parameters, combination medication did result in a slightly higher frequency of constipation.

Conclusions: When compared to solifenacin 5 mg monotherapy, combination therapy with solifenacin/mirabegron markedly improved OABSS, micturition frequency, and urgency. When compared to monotherapy, all combinations were well tolerated and showed no significant extra safety concerns.