Female Urology Trospium 60 mg Once Daily (QD) for Overactive Bladder Syndrome: Results from a Placebo-Controlled Interventional Study Roger R. Dmochowski, Peter K. Sand, Norman R. Zinner, and David R. Staskin OBJECTIVES A once-daily (QD) formulation of trospium chloride has been developed for the management of overactive bladder syndrome (OAB). This randomized controlled trial evaluated the efficacy and tolerability of this new extended-release formulation, trospium chloride 60 mg QD. METHODS Adults with OAB with urinary urgency, frequency, and urgency urinary incontinence (UUI) were eligible for inclusion. Subjects received trospium 60 mg QD or placebo for 12 weeks. Change in the mean number of toilet voids per day and UUI episodes per day were the primary outcome variables. Changes in urgency severity were also assessed and adverse events (AEs) were recorded. RESULTS Overall, 564 subjects participated in the study (trospium QD 280; placebo 284). Trospium QD demonstrated significant improvement in both primary outcome variables. The mean number of toilet voids per day was reduced from approximately 13 at baseline to 10.3 for trospium QD versus 11.1 for placebo (P 0.001) at week 12, whereas the number of UUI episodes per day was reduced from approximately 4 at baseline to 1.7 at week 12 with trospium QD versus 2.4 for placebo (P 0.001). Trospium QD also reduced urgency severity (P 0.001) and increased voided volume (P 0.01) compared with placebo. Benefits over placebo were apparent within the first week of treatment. Trospium QD was well tolerated; the most frequent AEs being dry mouth (trospium QD 12.9%; placebo 4.6%) and constipation (7.5% versus 1.8%, respectively). Central nervous system side effects were rarely observed and were comparable between groups. CONCLUSIONS Trospium QD represents a convenient, effective, and well-tolerated treatment option for OAB. UROLOGY 71: 449 – 454, 2008. © 2008 Elsevier Inc. O veractive bladder syndrome (OAB) is a debili- tating disorder characterized by symptoms of uri- nary urgency, often accompanied by urinary fre- quency, urgency urinary incontinence (UUI), and nocturia. 1 In the United States, approximately 33 million adults are affected by OAB of varying severity, 2 a large proportion of whom do not currently receive any effec- tive treatment. Although not usually life-threatening, OAB often exerts profoundly detrimental effects on qual- ity of life (QoL) and the ability to work effectively, with resultant financial as well as mental health burdens. 3–7 The underlying pathophysiology of urgency, frequency, and UUI that typifies OAB is not well understood. Emerging data have implicated a variety of mechanisms, including pathologic changes within the bladder smooth muscle itself, inappropriate sensitization of afferent nerve terminals within the bladder urothelium, increased activ- ity of the autonomic nervous system resulting in aberrant bladder contractions, or a central effect at the level of the brain or spinal cord. 8 –11 Indeed, it is likely that OAB has a heterogeneous cause. However, regardless of the patho- physiology, the current mainstay of treatment for OAB is This study was supported by Esprit Pharma and Indevus Pharmaceuticals Inc. Dr Dmochowski has acted as a consultant for the following companies: Esprit Pharma, Indevus Pharmaceuticals Inc, Allergan, Novartis, Pfizer, and Watson. Dr Sand has acted as a consultant for the following companies: Esprit Pharma, Indevus Pharmaceuticals Inc, Ortho, Allergan, Watson, GSK, Astellas, and Schwarz Pharma. In addition, Dr Sand has also been an investigator in clinical trials for the following companies: Esprit Pharma, Indevus Pharmaceuticals Inc, Ortho, Allergan, Watson, and Astellas, and has participated in meetings for the following companies: Esprit Pharma, Indevus Pharmaceuticals Inc, Ortho, Allergan, Watson, GSK, and Astellas. Dr Zinner has acted as a consultant for the following companies: Esprit Pharma, Indevus Pharmaceuticals Inc, Novartis, Watson, Eli Lilly, GSK, Allergan, Astellas, and Medtronics. In addition, Dr Zinner has also been an investigator on clinical trials for the following companies Esprit Pharma, Indevus Pharmaceuticals Inc, Novartis, Watson, GSK, Allergan, and Astellas, and has participated in meetings for the following companies: Esprit Pharma, Indevus Pharmaceuticals Inc., Eli Lilly, and Astellas. Dr Staskin has acted as a consultant for the following companies: Esprit Pharma, Indevus Pharmaceuticals Inc, Ortho-McNeil, Novartis, Watson, Pfizer, and Astellas. From the Department of Urology, Vanderbilt University School of Medicine, Nash- ville, Tennessee; Division of Urogynecology and Reconstructive Pelvic Surgery, Evan- ston Continence Center, Northwestern University, Feinberg School of Medicine, Evan- ston, Illinois; Western Clinical Research, Torrance, California; and Department of Urology, New York Presbyterian Hospital, Weill-Cornell Medical College, New York, New York Reprint requests: Roger Dmochowski, M.D., Department of Urology, Vanderbilt University School of Medicine, Room A 1302, Medical Center North, Nashville, TN 37232. E-mail: roger.dmochowski@vanderbilt.edu Submitted: May 1, 2007, accepted (with revisions): November 2, 2007. © 2008 Elsevier Inc. 0090-4295/08/$34.00 449 All Rights Reserved doi:10.1016/j.urology.2007.11.008