Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.

Pfizer

Status and phase: Completed; Phase 3

Conditions: Overactive Bladder

Treatments: Drug: fesoterodine fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00658684

A0221006

Details and patient eligibility

About

To assess the long term safety, tolerability and efficacy of fesoterodine in patients with OAB.

Enrollment: 153 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult OAB patients who present with OAB symptoms, including micturitions >= 8 per day and urinary urgency episodes >=1 per day.

Exclusion criteria

• Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients.
• Patient has a known neurological disease influencing bladder function.
• Patient has a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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153 participants in 1 patient group

Fesoterodine fumarate

Experimental group

Treatment:

Drug: fesoterodine fumarate