- Adult subjects with overactive bladder symptoms (subject-reported) for greater than or
equal to 3 months prior to Screening/Enrollment visit.
- Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary
prior to the Randomization/Baseline visit
- Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours as
verified by the 3-day bladder diary prior to randomization/Baseline visit.
- Subjects with any condition that would contraindicate their usage of fesoterodine
including: hypersensitivity to the active substance (fesoterodine fumarate) or to
peanut or soya or any of the excipients, urinary retention, gastric retention,
uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment
(Child Pugh C), severe ulcerative colitis, and toxic megacolon.
- Subjects with clinically significant hepatic or renal disease or other significant
- OAB symptoms caused by neurological conditions, known pathologies of urinary tract,
- Subjects with previous history of acute urinary retention requiring catheterization,
or severe voiding difficulties in the judgment of the investigator, prior to baseline.