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. (SOFIA)

Pfizer

Status and phase: Completed; Phase 4

Conditions: Urinary Bladder, Overactive

Treatments: Drug: Fesoterodine fumarate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00798434

A0221045

Details and patient eligibility

About

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.

Enrollment: 794 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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794 participants in 2 patient groups

Placebo

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo

Fesoterodine

Active Comparator group

Description:

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.

Treatment:

Drug: Fesoterodine fumarate