Efficacy and Tolerability of Solifenacin Fumarate with Overactive Bladder Patients: A Multicenter Observational Study

Abstract

Purpose: Overactive bladder (OAB) is characterized by a series of highly prevalent symptoms among older adults. This study used the Overactive Bladder Symptom Score (OABSS) and Patient Perception of Bladder Condition (PPBC) tools to evaluate the efficacy and stability of solifenacin fumarate in the treatment of OAB. Materials and Methods: This was a prospective, multicenter, single-arm, 12-week study that enrolled 163 OAB patients. The patients received 5 mg/day of solifenacin fumarate. The changes in the OABSS, symptoms, and PPBC scores were evaluated at 0, 4, and 12 weeks. Subgroup analysis of the OABSS and PPBC scores based on sex, diabetes mellitus (DM) status, and body mass index (BMI) were also evaluated. Results: At the baseline (week 0), the mean OABSS for all patients was 8. 45±2.38 (p=0.199). Subsequently, the mean OABSS declined to 5.41±2.69 (p=0.255) at four weeks and 4.21±2.61 (p=0.240) at 12 weeks. The OABSS subscore and PPBC score decreased significantly during the study (p＜0.01). After cases were stratified according to sex, DM status, and BMI, the mean OABSS (mean and subscore) and PPBC score at four and 12 weeks were also improved significantly relative to the baseline scores (both p＜0.05). The overall incidence of adverse events was 7.36% (12 cases), and three patients (1.82%) permanently discontinued solifenacin fumarate because of the adverse events. Conclusions: Solifenacin fumarate is a safe and effective treatment alternative for relieving OAB symptoms, considering the balance between the efficacy, patientsʼ well-being, and tolerability.