Trospium 60 mg Once Daily (QD) for Overactive Bladder Syndrome: Results from a Placebo-Controlled Interventional Study

• Published in: Urology (Ridgewood, N.J.) N.J.), 2008-03, Vol.71 (3), p.449-454
• Main Authors: Dmochowski, Roger R, Sand, Peter K, Zinner, Norman R, Staskin, David R
• Format: Article
• Language: English
• Subjects: Benzilates; Biological and medical sciences; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Medical sciences; Middle Aged; Nephrology. Urinary tract diseases; Nortropanes - administration & dosage; Prospective Studies; Urinary Bladder, Overactive - drug therapy; Urinary system involvement in other diseases. Miscellaneous; Urinary tract. Prostate gland; Urology
• ISSN: 0090-4295; 1527-9995
• DOI: 10.1016/j.urology.2007.11.008

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