Abstract | PURPOSE: MATERIALS AND METHODS: This was a randomized, double-blind, placebo controlled, multicenter trial performed in the United States. Overall 836 subjects with urinary frequency, urinary urgency or urgency urinary incontinence were randomized to placebo (274), 4 mg fesoterodine (283) or 8 mg fesoterodine (279) once daily for 12 weeks. The primary efficacy end point was the change in the number of micturitions per 24 hours. Co-primary end points were the change in the number of urgency urinary incontinence episodes per 24 hours and the treatment response. Secondary efficacy end points were other bladder diary variables, such as the change in mean voided volume per micturition, number of continent days and number of urgency episodes per 24 hours. Tolerability and safety were assessed by evaluating adverse events, electrocardiograms, post-void residual urine volume, laboratory parameters and treatment withdrawals. RESULTS: Treatment with 4 or 8 mg fesoterodine resulted in statistically significant and clinically relevant improvements from baseline to end of treatment for the primary and co-primary end points compared with placebo (p <0.05). Results for most secondary end points, including mean voided volume per micturition, number of continent days and number of urgency episodes per 24 hours, were also significantly improved vs placebo. The adverse events reported more frequently with fesoterodine than with placebo were dry mouth, constipation and urinary tract infection. CONCLUSIONS:
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Authors | Victor W Nitti, Roger Dmochowski, Peter K Sand, Hans-Theo Forst, Cornelia Haag-Molkenteller, Ute Massow, Joseph Wang, Marina Brodsky, Tamara Bavendam |
Journal | The Journal of urology
(J Urol)
Vol. 178
Issue 6
Pg. 2488-94
(Dec 2007)
ISSN: 1527-3792 [Electronic] United States |
PMID | 17937959
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
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Topics |
- Administration, Oral
- Adult
- Aged
- Aged, 80 and over
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Administration Schedule
- Female
- Follow-Up Studies
- Humans
- Male
- Maximum Tolerated Dose
- Middle Aged
- Multivariate Analysis
- Muscarinic Antagonists
(administration & dosage)
- Probability
- Reference Values
- Risk Assessment
- Severity of Illness Index
- Statistics, Nonparametric
- Treatment Outcome
- Urinary Bladder, Overactive
(diagnosis, drug therapy)
- Urodynamics
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