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

Terminated

• Conditions: Bladder Function
• Interventions: Procedure: cystometry (CMG); Procedure: polysomnography (PSG)

• Registration Number: NCT01099345
• Lead Sponsor: Astellas Pharma Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-30
• Study First Submitted QC: 2010-04-06
• Study First Posted: 2010-04-07
• Study Start: 2010-07
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-02
• Last Update Posted: 2014-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1 - OAB with DO+	cystometry (CMG)	Subjects that DO+ nocturia
Group 1 - OAB with DO+	polysomnography (PSG)	Subjects that DO+ nocturia
Group 2- OAB with DO-	cystometry (CMG)	Subjects that DO- nocturia
Group 2- OAB with DO-	polysomnography (PSG)	Subjects that DO- nocturia

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States