Fesoterodine Flexible Dose Study

Pfizer

Status and phase: Completed; Phase 3

Conditions: Overactive Bladder

Treatments: Drug: Fesoterodine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00536484

A0221014

Details and patient eligibility

About

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.

Enrollment: 896 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

896 participants in 2 patient groups, including a placebo group

Fesoterodine (Double-Blind)

Experimental group

Treatment:

Drug: Fesoterodine

Placebo (Double-Blind)

Placebo Comparator group

Treatment:

Drug: Placebo