|A Study to Compare the Effectiveness and Safety of Fesoterodine and Placebo in an Elderly Population of Patients Who go to the Toilet Very Frequently Due to Overactive Bladder.|
|A 24-Week, Multi-Centre Trial, Comprising A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Phase Followed By A 12-Week Open-Label Phase, To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Elderly Patients With Overactive Bladder.|
|The drug being studied, fesoterodine fumarate helps prevent the bladder neck opening at unwanted times and has been shown to help patients with overactive bladder syndrome pass urine less frequently than before treatment. It is postulated that this drug will also prove effective in elderly patients (aged > 65 years) and that the ability to change dose between 4 and 8mg will allow each patient to have an optimised treatment.|
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Urinary Bladder, Overactive|
- Drug: Placebo
placebo administered orally in the morning or evening.
- Drug: Fesoterodine fumarate
Fesoterodine fumarate is an antimuscarinic drug recently approved by the European Medicines Evaluation Agency for treatment of symptoms of overactive bladder syndrome.
Other Name: Toviaz
- Active Comparator: Placebo
Flexible dose regimen of placebo once daily. The dose can be increased after 4 weeks if clinically indicated. Subsequently the dose can be reduced to the original dose if clinically indicated.
Intervention: Drug: Placebo
- Active Comparator: Fesoterodine
Flexible dose regimen of fesoterodine fumarate 4mg once daily. The dose can be increased to 8mg once daily after 4 weeks if clinically indicated. Subsequently the dose can be reduced to 4mg if clinically indicated.
Intervention: Drug: Fesoterodine fumarate
|Wagg A, Khullar V, Michel MC, Oelke M, Darekar A, Bitoun CE. Long-term safety, tolerability and efficacy of flexible-dose fesoterodine in elderly patients with overactive bladder: open-label extension of the SOFIA trial. Neurourol Urodyn. 2014 Jan;33(1):106-14. doi: 10.1002/nau.22383. Epub 2013 Mar 4.|
|September 2010 (Final data collection date for primary outcome measure)|
- Male or female ?65 years old.
- Overactive bladder symptoms for at least 3 months prior to study start.
- Eight or more micturitions per 24 hours as confirmed by diary records
- Predominant Stress Urinary Incontinence
- Active or recurrent bladder infections
- Other bladder and genital conditions that could be the predominant cause of symptoms or interfere with treatment assessment and success.
|Sexes Eligible for Study:||All|
|65 Years and older (Older Adult)|
|Contact information is only displayed when the study is recruiting subjects|
|Austria, Belgium, Denmark, Finland, Germany, Israel, Italy, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|