A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency

Pfizer

Status and phase: Completed; Phase 4

Conditions: Overactive Bladder

Treatments: Drug: Placebo; Drug: Fesoterodine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00911937

A0221048

Details and patient eligibility

About

This study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on micturition related nocturnal urgency episodes.

Enrollment: 963 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mean urinary frequency of >=8 micturitions per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in visit (Visit 2)
• Mean number of micturition related urgency episodes >=3 per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in /Visit 2 (Urgency episodes are defined as those with Urinary Sensation Scale rating >=3)
• Mean number of micturition related nocturnal urgency episodes >=2 but no more than 8 episodes per 24 hours as verified by the bladder diary at Visit 2 (nocturnal urgency episodes are defined as those with Urinary Sensation Scale rating of >3 recorded in the bed time section of the bladder diary)

Exclusion criteria

• A known recent history or previous diagnosis of any sleep disorder such as obstructive sleep apnea, primary insomnia, periodic limb movement, parasomnia
• Nocturia due to other underlying uncontrolled conditions, such as congestive heart failure, diabetes mellitus, diabetes insipidus, polyuria of any cause, etc.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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963 participants in 2 patient groups, including a placebo group

Fesoterodine

Experimental group

Treatment:

Drug: Fesoterodine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo