A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder

Pfizer

Status and phase: Completed; Phase 4

Conditions: Overactive Bladder

Treatments: Drug: Placebo; Drug: Fesoterodine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00928070

A0221049

Details and patient eligibility

About

This study is designed to assess the efficacy and safety of a flexible dose regimen of fesoterodine on urgency urinary incontinence (UUI) episodes in vulnerable elderly subjects with overactive bladder (OAB).

Enrollment: 566 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male or female subjects 65 years of age or older
• OAB symptoms for at least 3 months
• score 3 or greater on Vulnerable Elderly Survey (VES-13)
• adequate mobility for independent toileting
• mean number of at least 2 UUI episodes per 24 hours
• mean urinary frequency of 8 or more micturitions per 24 hours
• able to independently complete the bladder diaries

Exclusion criteria

• PVR urinary volume greater than 200 ml
• MMSE score less than 20
• greater than 15 UUI episodes per 24 hours
• creatinine clearance less than 30 ml/min
• an average resting heart rate of greater than or equal to 90 beats per minute

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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566 participants in 2 patient groups, including a placebo group

Fesoterodine

Experimental group

Treatment:

Drug: Fesoterodine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo