Fesoterodine fumarate is used in the management of overactive bladder for the relief of symptoms associated with voiding such as urge urinary incontinence, urgency, and frequency.
Safety and efficacy of fesoterodine for this indication were established in two 12-week, phase 3, randomized, double-blind, placebo-controlled studies in more than 1900 patients with symptoms of urinary incontinence, urgency, and urinary frequency that had persisted for at least 6 months. In both studies, patients received fesoterodine fumarate 4 or 8 mg once daily or placebo; in one of these studies, 290 patients were randomized to an active control arm (an oral antimuscarinic agent). In these studies, fesoterodine fumarate 4 or 8 mg daily was more effective than placebo in reducing the number of micturitions and urge incontinence episodes per 24 hours and increasing the volume of urine voided per micturition. Urinary frequency was decreased from baseline by 1.74-1.94 or 1.02 micturitions per 24 hours, urge incontinence episodes were decreased from baseline by 1.77-2.42 or 1-1.2 occurrences per 24 hours, and urine volume voided per micturition was increased by 17-33 or 8-10 mL per micturition in patients receiving fesoterodine or placebo, respectively. A reduction in the number of urge incontinence episodes per 24 hours was observed for both dosages as compared with placebo as early as 2 weeks after starting fesoterodine therapy. In a pooled analysis of data from these 2 studies, the 8-mg daily dosage was more effective than the 4-mg daily dosage in improving urge incontinence episodes, treatment response, volume of urine voided, and number of continent days per week.
In addition to objective improvements, a beneficial effect on health-related quality-of-life scores has been demonstrated with fesoterodine compared with placebo. In an analysis of pooled data from two 12-week studies in patients with overactive bladder, treatment with fesoterodine fumarate 4 or 8 mg daily was associated with improvements in many aspects of health-related quality of life (e.g., incontinence impact, role limitations, physical limitations, sleep/energy, severity/coping, emotions, social limitations, personal relationships [ 8-mg dosage only]).