A randomized, controlled trial of effectiveness and safety of management of OAB symptoms in elderly men and women with standard-dosed combination of solifenacin and mirabegron

Objectives: Comparison of effectiveness and safety of solifenacin and mirabegron, as well as their combination, for managing heavy symptoms of overactive bladder. Materials and methods: All patients who participated in the examination (average age: 71.2) were split into 4 groups. Patients included in Group A (n = 63) were treated with mirabegron 50 mg/day/6 weeks, in Group B (n = 52)-with solifenacin 10 mg/day/6 weeks, in Group E (n = 65)-with the same doses of both drugs simultaneously/6 weeks, and in Group D (n = 59)-with placebo. Monitoring was carried out using OAB-questionnaires, bladder diaries and urodynamic examination. Results: In elderly patients with initial frequency of episodes of incontinence (EI) > 3/day standard doses of mirabegron (50 mg/day) and solifenacin 10 mg/day administered during 6 weeks result with the decrease in frequency of EI with high correlation (r = 0,74, p <= 0.05); final results in both groups are significantly different from initial value of p <= 0.05. In the group, where patients were taking both drugs simultaneously, final results significantly differ from both initial values of the parameters in these groups (EI: 5.1 -> 1.6 per day, p < 0.01; urination: 9.1 -> 5.3 per day, p < 0.01; post-void residual 19.4 -> 29.9, p <= 0.01) and final values in Groups A and B (p <= 0.05). The percentage of side effects in this group does not significantly differ from that in the groups, where patients were receiving monotherapy. Conclusion: Combined treatment for severe symptoms of OAB in elderly men and women with standard doses of solifenacin and mirabegron provides satisfactory therapeutic effect within short period of time without increasing the risk of side effects, which undoubtedly improves quality of life and self-esteem of patients. At the same time, taking any of these drugs separately for the treatment of severe malfunction of lover urinary tracts in elderly people may turn out to be insufficient for effective symptom management. (C) 2015 Elsevier Ireland Ltd. All rights reserved.