Fesoterodine Flexible Dose Study

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This Phase 3B study is designed to test if a fesoterodine flexible dose regimen is more effective than placebo in reducing micturition frequency and other overactive bladder (OAB) symptoms, e.g., urgency, urgency incontinence episodes in patients with overactive bladder and if the fesoterodine regimen is safe and well tolerated.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Fesoterodine

Criteria

Inclusion Criteria:

• Overactive bladder symptoms for greater than or equal to 3 months.

• Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours in bladder diary.

• Mean number of Urgency episodes greater than or equal to 3 per 24 hours in bladder diary.

Exclusion Criteria:

• Contraindication to fesoterodine (antimuscarinics).

• Known etiology of OAB (e.g., neurogenic, local urinary tract pathology).

• 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.