A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients

Pfizer

Status and phase: Completed; Phase 3

Conditions: Overactive Bladder

Treatments: Drug: fesoterodine fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00425100

A0221007

Details and patient eligibility

About

To evaluate the effect of fesoterodine on patient satisfaction and overactive bladder (OAB) symptom relief in OAB patients who were dissatisfied with their prior therapy with tolterodine.

Enrollment: 516 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• OAB patients who present with OAB symptoms(≥8 micturitions and ≥3 urgency episodes per 24 h documented in the baseline bladder diary)
• OAB patients dissatisfied with their prior therapy with tolterodine

Exclusion criteria

• Patients with any contraindication to fesoterodine usage, e.g., urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, or known hypersensitivity to the drug or its ingredients.
• Patients with significant hepatic and renal disease or other significant unstable diseases.
• OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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516 participants in 1 patient group

Open Label-fesoterodine

Experimental group

Description:

Single treatment study arm.

Treatment:

Drug: fesoterodine fumarate