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

Stopped early

Conditions studied: Bladder Function

In brief

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.

Key facts

Study ID

NCT01099345

Run by

Astellas Pharma Inc

People needed

15

Starts

2010-07-01

Expected to finish

2012-05-01

Last updated by the study team

2014-06-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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