INTRODUCTION AND HYPOTHESIS: In overactive bladder (OAB), subjects' most bothersome symptom (MBS) may influence treatment-related outcomes. We evaluated effects of solifenacin on patient-reported outcomes (PROs) in subjects stratified by their MBS at baseline. METHODS: In a 12-week, open-label study, the effects of solifenacin on PROs were assessed using visual analog scales (VAS), the OAB questionnaire (OAB-q), and the patient perception of bladder condition (PPBC). Statistics were descriptive. RESULTS: Subjects' baseline MBS were frequency (27%), urge urinary incontinence (UUI; 26%), urgency (23%), and nocturia (15%); VAS scores were worse for MBS. By study end, participants' MBS showed the largest solifenacin-related VAS improvements. The UUI subgroup showed the largest VAS, OAB-q, and PPBC improvements. CONCLUSIONS:Solifenacin improved overall and symptom-specific bother, HRQL, and perception of their bladder condition in MBS subgroups, with larger improvements in subjects' MBS. Those with UUI as MBS showed greater improvement in most outcomes.
RCT Entities:
INTRODUCTION AND HYPOTHESIS: In overactive bladder (OAB), subjects' most bothersome symptom (MBS) may influence treatment-related outcomes. We evaluated effects of solifenacin on patient-reported outcomes (PROs) in subjects stratified by their MBS at baseline. METHODS: In a 12-week, open-label study, the effects of solifenacin on PROs were assessed using visual analog scales (VAS), the OAB questionnaire (OAB-q), and the patient perception of bladder condition (PPBC). Statistics were descriptive. RESULTS: Subjects' baseline MBS were frequency (27%), urge urinary incontinence (UUI; 26%), urgency (23%), and nocturia (15%); VAS scores were worse for MBS. By study end, participants' MBS showed the largest solifenacin-related VAS improvements. The UUI subgroup showed the largest VAS, OAB-q, and PPBC improvements. CONCLUSIONS:Solifenacin improved overall and symptom-specific bother, HRQL, and perception of their bladder condition in MBS subgroups, with larger improvements in subjects' MBS. Those with UUI as MBS showed greater improvement in most outcomes.
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