ORIGINAL ARTICLE Trospium chloride extended release is effective and well tolerated in women with overactive bladder syndrome Peter K. Sand & Roger R. Dmochowski & Norman R. Zinner & David R. Staskin & Rodney A. Appell Received: 23 March 2009 / Accepted: 14 July 2009 / Published online: 29 August 2009 # The International Urogynecological Association 2009 Abstract Introduction and hypothesis To confirm the efficacy and tolerability of extended release (ER) trospium chloride in women with overactive bladder syndrome (OAB), data from two identical phase III studies were analyzed. Methods Adults (aged ≥ 18 years) who had OAB with urinary urgency, frequency, and urge urinary incontinence (UUI) were randomized to trospium ER 60 mg or placebo once daily for 12 weeks. The analysis included 989 women (trospium ER, n =484; placebo, n =505). Endpoints exam- ined included changes from baseline in number of toilet voids and UUI episodes/day at week 12. Continuous data were analyzed using rank analysis of variance. Results At week 12, significantly greater mean reductions in numbers of toilet voids and UUI episodes/day occurred with trospium ER versus placebo (P <0.0001). Adverse events considered at least possibly related to treatment with trospium ER included dry mouth (11.4%) and constipation (8.9%). Conclusions Trospium ER was effective and well tolerated in women with OAB. Keywords Overactive bladder syndrome . Trospium chloride . Urinary incontinence . Women Introduction Overactive bladder syndrome (OAB) affects approximately 17% of women in the USA [1], often exerting profoundly detrimental effects on their quality of life (QoL), self- esteem, family relationships, sexual and intimate relation- ships, and their work or professional lives [2]. Although the prevalence of OAB is similar in men and women, the symptomatology and impact may be different, with women showing a higher prevalence of urge urinary incontinence (UUI) than men, and a greater use of non-medical strategies (e.g., physiotherapy and pad use) to cope with their condition [3]. Oral antimuscarinic therapy forms the mainstay of pharmacologic management for OAB. Historically, rates of persistence with OAB treatment have been low, with key reasons for treatment discontinuation including issues with efficacy, adverse effects, and sometimes cost [4]. Current US Food and Drug Administration-approved antimuscar- Rodney A. Appell: deceased P. K. Sand Division of Urogynecology and Reconstructive Surgery, NorthShore University HealthSystem, Pritzker School of Medicine, University of Chicago, Evanston, IL, USA R. R. Dmochowski Vanderbilt University School of Medicine, Nashville, TN, USA N. R. Zinner Western Clinical Research, Torrance, CA, USA D. R. Staskin Division of Urology, Caritas St. Elizabeth’ s Medical Center, Tufts University School of Medicine, Boston, MA, USA R. A. Appell Baylor College of Medicine, Houston, TX, USA P. K. Sand (*) Evanston Continence Center, 1000 Central Street, Suite 730, Evanston, IL 60201, USA e-mail: psand@northshore.org Int Urogynecol J (2009) 20:1431–1438 DOI 10.1007/s00192-009-0969-8