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

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Fesoterodine

Criteria

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