Clinical trial NCT01099345: A Pilot Trial in a Sleep Laboratory Setting to Observe Night Time Bladder Function of Subjects With Overactive Bladder (OAB)
Official title: A Pilot, Overactive Bladder Syndrome Study Utilizing a Sleep Laboratory Setting to Compare Detrusor Positive Nocturia Female Subjects to Detrusor Negative Nocturia Female Subjects
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bladder Function
Keywords: OAB
Nocturia
Bladder function
cystometry
polysomnography
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-04-07
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects identified through urology physicians, family practice physicians and advertising

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.


Eligibility 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

Primary outcomes:
measure: Average nocturia individual volume void
timeFrame: During night in sleep lab
measure: Nocturnal functional bladder capacity
timeFrame: During night in sleep lab
measure: Total urine production
timeFrame: During night in sleep lab
Secondary outcomes:
measure: Total wake time from lights out until getting out of bed in the morning
timeFrame: During night in sleep lab
measure: Average urgency rating
timeFrame: During night in sleep lab
measure: Number of nocturias with urgency ≥3
timeFrame: During night in sleep lab
measure: Percentage of subjects with ≥ 2 nocturias
timeFrame: During night in sleep lab
measure: Time from awakening to void on CMG/PSG
timeFrame: During night in sleep lab
measure: Number of awakenings
timeFrame: During night in sleep lab
measure: Wake time after sleep onset
timeFrame: During night in sleep lab
measure: Sleep onset latency
timeFrame: During night in sleep lab
measure: For DO+ subjects, number of nocturias associated with DO+
timeFrame: During night in sleep lab
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Astellas Pharma Global Development
name: Medical Director
role: STUDY_DIRECTOR
References: