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



Status:Completed
Conditions:Overactive Bladder
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:12/6/2018
Start Date:August 2009
End Date:September 2011

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A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Trial To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency.

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


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.
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