Efficacy and Safety of Solifenacin Succinate for Urinary Difficulty in Brain Lesion: Multicenter Prospective Study

ABSTRACT

OBJECTIVE: We studied the efficacy and safety of solifenacin for urinary difficulty in brain lesion from multicenter prospective study. METHOD: Eighty patients with brain lesion who visited from 5 multicenter department of rehabilitation medicine from May 2009 to June 2010 were included. Patients were treated with solifenacin 5 mg to 10 mg for 12 weeks. The outcome measure was mean change in daily micturation frequency, daily frequency of incontinence, urgency episodes, and nocturia episodes from baseline to week 12. Patient's attitude to drug was assessed using the BSW Questionnaire (Benefit, Satisfaction and Willingness to Continue Questions). RESULTS: Sixty-one of 80 were evaluated for effect. All voiding parameters showed significant improvement after 12 weeks of treatment (p<0.05). There was no significant difference in efficacy of solifenacin between ischemic and hemorrhagic stroke. A twenty-two patients experienced 27 adverse events (AE). The most frequent AE were dry mouth (12.5%) and constipation (6.3%). Treatment related adverse events with solifenacin were mainly mild in severity, and only led to discontinuation in 6.3% of patients. CONCLUSION: Solifenacin succinate improve urinary difficulty symptoms with acceptable efficacy and safety in patient with brain lesion.