ORIGINAL ARTICLE Efficacy and tolerability of fesoterodine in women with overactive bladder Peter K. Sand & Jon D. Morrow & Tamara Bavendam & Dana L. Creanga & Victor W. Nitti Received: 8 December 2008 / Accepted: 1 March 2009 / Published online: 17 March 2009 # The International Urogynecological Association 2009 Abstract Introduction and hypothesis We assessed fesoterodine efficacy and tolerability in women with overactive bladder (OAB). Methods This post hoc analysis of pooled data from two clinical trials included 1,548 women with OAB randomized to placebo, fesoterodine 4 or 8 mg, or tolterodine extended release (ER) 4 mg (in 1 trial) for 12 weeks. Subjects completed 3-day bladder diaries at baseline and weeks 2 and 12 and rated Treatment Response at weeks 2 and 12. Results By weeks 2 and 12, all active-treatment groups showed significant improvements in all five bladder diary variables assessed and greater Treatment Response rates vs placebo. Fesoterodine 8 mg was significantly more effica- cious than fesoterodine 4 mg and tolterodine ER in improving urgency urinary incontinence episodes and continent days per week. The most common adverse events were dry mouth and constipation, which were predomi- nately mild or moderate. Conclusions Fesoterodine is efficacious and well tolerated in women with OAB. Keywords Antimuscarinic . Dose response . Incontinence . Overactive bladder . Treatment response Abbreviations 5-HMT 5-Hydroxymethyl tolterodine AE Adverse event ANCOVA Analysis of covariance CYP Cytochrome P450 EOT End of treatment ER Extended release FESO Fesoterodine HRQL Health-related quality of life LOCF Last observation carried forward LSM Least squares mean OAB Overactive bladder MVV Mean voided volume PBO Placebo SD Standard deviation SEM Standard error of the mean TOL ER Tolterodine ER UUI Urgency urinary incontinence Introduction Overactive bladder (OAB) is prevalent in women, with a prevalence estimate of approximately 13% [1] in a large population-based study conducted in North America and in Europe. In addition to creating an economic burden [2], OAB symptoms, especially urgency urinary incontinence (UUI), have an adverse impact on several aspects of health- Int Urogynecol J (2009) 20:827–835 DOI 10.1007/s00192-009-0857-2 P. K. Sand (*) Evanston Continence Center, Department of Obstetrics and Gynecology, Northwestern University, Feinberg School of Medicine, 1000 Central Street, Suite 730, Evanston, IL 60201, USA e-mail: p-sand@northwestern.edu J. D. Morrow : T. Bavendam : D. L. Creanga Pfizer Inc, New York, NY, USA V. W. Nitti New York University Medical Center, New York, NY, USA