A Pilot, Overactive Bladder Syndrome Study Utilizing a Sleep Laboratory Setting to Compare Detrusor Positive Nocturia Female Subjects to Detrusor Negative Nocturia Female Subjects

Astellas Pharma Inc1 site in 1 country15 target enrollmentJuly 2010

ConditionsBladder Function

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Bladder Function
Sponsor: Astellas Pharma Inc
Enrollment: 15
Locations: 1
Primary Endpoint: Average nocturia individual volume void
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

July 2010

End Date

May 2012

Last Updated

11 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Astellas Pharma Inc

Responsible Party

Sponsor

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

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)