Fesoterodine "add-on" Male Overactive Bladder Study

Pfizer

Status and phase: Completed; Phase 3

Conditions: Overactive Bladder Syndrome

Treatments: Drug: Fesoterodine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00546637

A0221009

Details and patient eligibility

About

To evaluate the efficacy and safety of fesoterodine on overactive bladder symptom improvement when added to ongoing alpha blocker treatment.

Enrollment: 947 patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men aged 40 years and above.
• On a stable and well-tolerated dose of an alpha-blocker prescribed for LUTS for at least 6 weeks prior to screening (Visit 1).
• Persistent symptoms of OAB with urinary frequency >=8 times/24 hours and micturition-related urgency episodes >=3 episode/24 hours.

Exclusion criteria

• Contraindication to fesoterodine (antimuscarinics).
• Previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline.
• Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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947 participants in 2 patient groups, including a placebo group

Fesoterodine 4mg or 8mg

Experimental group

Treatment:

Drug: Fesoterodine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo