A Pilot Trial in a Sleep Laboratory Setting to Observe Night Time Bladder Function of Subjects With Overactive Bladder (OAB)
NCT01099345 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 15
Last updated 2014-06-04
Summary
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.
Conditions
- Bladder Function
Interventions
- PROCEDURE
-
cystometry (CMG)
recording device measuring pressures though catheters placed in bladder and rectum
- PROCEDURE
-
polysomnography (PSG)
Recording device measuring sleep activity through electrodes attached to the subject
Sponsors & Collaborators
-
Astellas Pharma Inc
lead INDUSTRY
Principal Investigators
-
Medical Director · Astellas Pharma Global Development
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-07-31
- Primary Completion
- 2012-05-31
- Completion
- 2012-05-31
Countries
- United States
Study Locations
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