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A Pilot Trial in a Sleep Laboratory Setting to Observe Night Time Bladder Function of Subjects With Overactive Bladder (OAB) - NCT01099345-27705(Clinical Trial 596984)



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City:  Durham
State:  
NC
Zip Code: 27705
Conditions: Bladder Function
Purpose: This is an observational, pilot, non-treatment study to evaluate and develop clinical variables for distinguishing female OAB subjects that have detrusor overactivity positive (DO+) nocturia from female OAB subjects that have detrusor overactivity negative (DO-) nocturia utilizing a sleep laboratory setting.
Study summary:
Criteria: Inclusion Criteria: - Subject must have confirmed diagnosis of OAB and OAB symptoms for ≥ 3 months - Subject must have documented detrusor overactivity - Subject must not be taking any OAB medication for at least 14 days - Subject has no sleep related conditions (other than nocturia) Exclusion Criteria: - Subject has active urinary tract infection (UTI) - Subject has significant stress incontinence or mixed stress/urge incontinence - Subject has nocturnal polyuria - Subject has history of sleep apnea - Subject has indwelling urinary catheterization within 4 weeks - Subject using medication that effects urinary and sleep function - Subject is unable to refrain from alcohol or smoking during the sleep night stay - Subject has an unstable medical or psychiatric disorder - Subject has a history of cardiovascular concerns - Subject is pregnant, breastfeeding or plans to become pregnant
Study is available at:
Durham, NC 27705
United States

Primary Contact:
Astellas Pharma Global Development
Email: clintrials.info@us.astellas.com
Phone: 800-888-7704
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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