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Urology. 2010 Dec;76(6):1350-7. doi: 10.1016/j.urology.2010.03.097. Epub 2010 Oct 25.

Efficacy and tolerability of fesoterodine in older and younger subjects with overactive bladder.

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  • 1University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.

Erratum in

  • Urology. 2011 Apr;77(4):1020.



To assess the effect of age on fesoterodine efficacy and tolerability in subjects with an overactive bladder.


The data from 2 randomized, 12-week studies of 1681 subjects treated with fesoterodine 4 or 8 mg or placebo were pooled and stratified by age. The subjects completed 3-day bladder diaries at baseline and weeks 2 and 12, the King's Health Questionnaire at baseline and week 12, and the Treatment Benefit Scale at week 12.


Of the subjects aged <65 years, fesoterodine 4 and 8 mg was associated with statistically significant improvements in the diary variables at week 12 versus placebo. Greater improvement in urgency urinary incontinence was seen with fesoterodine 8 mg versus 4 mg. For those aged ≥65 to <75 years, fesoterodine 4 and 8 mg significantly improved all diary variables, except for the mean voided volume and micturition frequency, respectively, [corrected] versus placebo. In subjects aged ≥75 years, fesoterodine 8 mg significantly improved all diary variables, except for mean voided volume, versus placebo. No significant improvements were observed with fesoterodine 4 mg versus placebo. Fesoterodine significantly improved several King's Health Questionnaire domains versus placebo in all age groups. Fesoterodine 4 mg did not significantly improve any domains in subjects aged ≥75 years. In all age groups, the treatment response rates were significantly greater with both fesoterodine doses versus placebo. Dry mouth and constipation occurred more frequently in subjects aged ≥75 years receiving fesoterodine 8 mg than in those receiving fesoterodine 4 mg or placebo, although the discontinuation rates because of dry mouth and constipation were not increased.


Fesoterodine 4 and 8 mg effectively treated overactive bladder symptoms in subjects aged <75 years. Fesoterodine 8 mg was effective in subjects aged ≥75 years.

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