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

NCT01099345 — Terminated, 15 participants, Astellas Pharma Inc

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

Registry	NCT01099345
Status	Terminated - Slow Enrollment
Study type	Observational
Enrollment	15 (Actual)
Sponsor	Astellas Pharma Inc (Industry)
Conditions	Bladder Function
Interventions	cystometry (CMG), polysomnography (PSG) (Procedure)
Dates	start 2010-07-01, primary completion 2012-05-01, completion 2012-05-01, first posted 2010-04-07, last updated 2014-06-04
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Group 1 - OAB with DO+		Procedure: cystometry (CMG); Procedure: polysomnography (PSG)	Subjects that DO+ nocturia
Group 2- OAB with DO-		Procedure: cystometry (CMG); Procedure: polysomnography (PSG)	Subjects that DO- nocturia

cystometry (CMG) (Procedure): recording device measuring pressures though catheters placed in bladder and rectum
polysomnography (PSG) (Procedure): Recording device measuring sleep activity through electrodes attached to the subject

+Outcome measures

Primary outcomes

Average nocturia individual volume void [During night in sleep lab]
Nocturnal functional bladder capacity [During night in sleep lab]
Total urine production [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]

+Eligibility

Sex: Female, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Duke University Medical Center	Durham, North Carolina	United States

+Investigators

Medical Director, Study director, Astellas Pharma Global Development