Solifenacin is effective for the treatment of OAB dry patients: A pooled analysis

Objective: The aim of this analysis was to determine the effects of solifenacin in patients considered overactive bladder (OAB) dry at baseline. Methods: This was a pooled analysis of 4 randomized, placebo-controlled 12-week, phase 3 studies. Patients received placebo or solifenacin 10 mg once daily (2 studies), or placebo or solifenacin 5 mg or 10 mg once daily (2 studies). A subgroup of patients without incontinence at baseline was identified from a 3-day diary. Mean changes from baseline to endpoint for urgency episodes, micturition, frequency and nocturia episodes per 24 hours, and volume voided/micturition were evaluated. The proportion of patients with normalization of micturition frequency (< 8 micturitions), resolution of urgency, or resolution of nocturia at endpoint was also determined. Results: Of 2848 evaluable patients treated with placebo or solifenacin, 975 (34%) were OAB dry at baseline. Solifenacin 5 mg and 10 mg were significantly (p < 0.001) more effective than placebo for improving urgency, micturition frequency, and volume voided. In addition, solifenacin 10 mg was significantly (p < 0.01) more effective than placebo for improving nocturia. Resolution of urgency occurred significantly (p < 0.05) more often with solifenacin 5 mg (37%) and 10 mg (33%) than with placebo (25%). Significantly (p < 0.01) more OAB dry patients had normalization of micturition frequency with solifenacin 5 mg (29%) and 10 mg (35%) compared with placebo (19%). Resolution of nocturia occurred in 14%, 21%, and 13% of patients treated with solifenacin 5 mg, solifenacin 10 mg, and placebo, respectively (p < 0.01 for solifenacin 10 mg versus placebo). Conclusion: Solifenacin significantly improved urgency, frequency, and nocturia symptoms and increased volume voided in OAB dry patients. (c) 2005 Published by Elsevier B.V.