Conditions: Urinary Bladder, Overactive
Keywords: Overactive bladder syndrome fesoterodine elderly flexible dose regimen urgency frequency urge urinary incontinence anticholinergic antimuscarinic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 794
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Placebo intervention 2: Fesoterodine fumarate
Intervention descriptions: intervention 1: placebo administered orally in the morning or evening. intervention 2: Fesoterodine fumarate is an antimuscarinic drug recently approved by the European Medicines Evaluation Agency for treatment of symptoms of overactive bladder syndrome.

Protocol document: