NCT01099345TerminatedNot Applicable
A Pilot, Overactive Bladder Syndrome Study Utilizing a Sleep Laboratory Setting to Compare Detrusor Positive Nocturia Female Subjects to Detrusor Negative Nocturia Female Subjects
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Average nocturia individual volume void
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Average nocturia individual volume void
Time Frame: During night in sleep lab
Nocturnal functional bladder capacity
Time Frame: During night in sleep lab
Total urine production
Time Frame: During night in sleep lab
Secondary Outcomes
- Total wake time from lights out until getting out of bed in the morning(During night in sleep lab)
- Average urgency rating(During night in sleep lab)
- Number of nocturias with urgency ≥3(During night in sleep lab)
- Percentage of subjects with ≥ 2 nocturias(During night in sleep lab)
- Time from awakening to void on CMG/PSG(During night in sleep lab)
- Number of awakenings(During night in sleep lab)
- Wake time after sleep onset(During night in sleep lab)
- Sleep onset latency(During night in sleep lab)
- For DO+ subjects, number of nocturias associated with DO+(During night in sleep lab)
Investigators
Study Sites (1)
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