Trial Information

(Overactive Bladder with Nocturia) A Phase IV, Double-Blind, Placebo-Controlled trial, to evaluate the efficacy and safety of a Fesoterodine Flexible Dose regimen in patients with symptoms of Overactive Bladder including Nocturnal Urinary Urgency

The purpose of this study is to test the safety and effectiveness of the study drug, fesoterodine, compared to placebo, on nocturnal urinary urgency episodes in subjects with overactive bladder (OAB). The trial will consist of five visits up to 12 weeks long. Fesoterodine is approved by the United States FDA for treatment of OAB.

Patient Inclusion Criteria:

Male of female age 18 years or older
Overactive bladder symptoms for more than 3 months prior to screening/enrolling
Able and willing to complete urinary diaries and all related questionnaires

Patient Exclusion Criteria:

Prior use of Fesoterodine (Toviaz)
A known diagnosis of any sleep disorder such as obstructive sleep apnea, primary insomnia, periodic limb movement, parasomnia
Nocturia due to another underlying uncontrolled condition such as congestive heart failure, diabetes mellitus, diabetes insipidus,
Neurological conditions such as stroke, multiple sclerosis, spinal cord injury, or Parkinson’s disease
History of interstitial cystitis or urogenital cancer

Nancy Manusov, Research Recruitment Specialist
Southeastern Research Group, Inc.
2000 Centre Pointe Boulevard
Tallahassee, FL 32308
Phone: 850-201-0411
Email: nmanusov@serginc.com

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Research Center Information: Southeastern Research Group, Inc.

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