12-week, randomized, double-blind, double-dummy, placebo-controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of fesoterodine in comparison to tolterodine ER in patients with overactive bladder.

Phase 3

Withdrawn

Conditions: loss of urinary
urgency urinary incontinence
10004994

Registration Number: NL-OMON31014

Lead Sponsor: Pfizer

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 50

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

-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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in mean number of urgency urinary incontinence (UUI) episodes per 24<br /><br>hours at week 12 relative to the baseline (UUI episodes are defined as those<br /><br>with Bladder Sensation Scale rating of 5 in the diary)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Patient's perception of Bladder Condition (PPBC)<br /><br>Patient perception of Urgencu Scale (PPUS)<br /><br>Overactive bladder questionnaire (OAB-q)<br /><br>Dispense micturition bladder diary (3-day)<br /><br>Evaluation of micturition bladder diary (3-day)</p><br>