loss of urinary urgency urinary incontinence
Conditions
Interventions
4 and 8 mg fesoterodine, 4 mg tolterodine and placebo, daily for 12 weeks.
Sponsors
Pfizer
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Overactive bladder symptoms for more than 3 months prior to screening/enrolment visit (visit 1) - Reported at least an everage of 1 UUI episode per 24 hours in the 3-day micturition diary prior to the randomization/baseline visit (visit 2)
Exclusion criteria
Exclusion criteria: -Any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active substance or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment, severe ulcerative colitis, and toxic megacolon. -Clinically significant hepatic or renal disease, and/or with a screening test of AST,ALT, ALP, urea nitrogen, or creatinine greater than 1.5 times of the upper limit of normal range (ULN) See for more exclusion criteria p.19-21
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean number of urgency urinary incontinence (UUI) episodes per 24 hours at week 12 relative to the baseline (UUI episodes are defined as those with Bladder Sensation Scale rating of 5 in the diary) | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient's perception of Bladder Condition (PPBC) Patient perception of Urgencu Scale (PPUS) Overactive bladder questionnaire (OAB-q) Dispense micturition bladder diary (3-day) Evaluation of micturition bladder diary (3-day) | — |
Countries
Netherlands
Outcome results
None listed