Clinical Health Updates

Fesoterodine effective for treating overactive bladder syndrome

Clinical Question:
Is fesoterodine effective and safe in the treatment of overactive bladder syndrome?

Bottom Line:
Fesoterodine reduces urinary urgency incontinent episodes by an average of one per day compared with placebo. Whether this difference is clinically significant is best made on an individual patient basis. Dry mouth is the most common reason for discontinuing active treatment.

Nitti VW, Dmochowski R, Sand PK, et al. Efficacy, safety and tolerability of fesoterodine for overactive bladder syndrome. J Urology 2007;178(6):2488-2494.

Study Design:
Randomized controlled trial (double-blinded)

The authors evaluated the efficacy, tolerability and safety of the new antimuscarinic agent fesoterodine relative to placebo for overactive bladder syndrome. This was a randomized, double-blind, placebo controlled, multicenter trial performed in the United States. Overall 836 subjects with urinary frequency, urinary urgency or urgency urinary incontinence were randomized to placebo (274), 4 mg fesoterodine (283) or 8 mg fesoterodine (279) once daily for 12 weeks. The primary efficacy end point was the change in the number of micturitions per 24 hours. Co-primary end points were the change in the number of urgency urinary incontinence episodes per 24 hours and the treatment response. Secondary efficacy end points were other bladder diary variables, such as the change in mean voided volume per micturition, number of continent days and number of urgency episodes per 24 hours. Tolerability and safety were assessed by evaluating adverse events, electrocardiograms, post-void residual urine volume, laboratory parameters and treatment withdrawals. Treatment with 4 or 8 mg fesoterodine resulted in statistically significant and clinically relevant improvements from baseline to end of treatment for the primary and co-primary end points compared with placebo (p <0.05). Results for most secondary end points, including mean voided volume per micturition, number of continent days and number of urgency episodes per 24 hours, were also significantly improved vs placebo. The adverse events reported more frequently with fesoterodine than with placebo were dry mouth, constipation and urinary tract infection.