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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bladder Function

Intervention / Treatment
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* Procedure: cystometry (CMG)
* Procedure: polysomnography (PSG)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1 - OAB with DO+<br>Subjects that DO+ nocturia | Procedure: cystometry (CMG)<br>* recording device measuring pressures though catheters placed in bladder and rectum<br>Procedure: polysomnography (PSG)<br>* Recording device measuring sleep activity through electrodes attached to the subject<br>|
| Group 2- OAB with DO-<br>Subjects that DO- nocturia | Procedure: cystometry (CMG)<br>* recording device measuring pressures though catheters placed in bladder and rectum<br>Procedure: polysomnography (PSG)<br>* Recording device measuring sleep activity through electrodes attached to the subject<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OAB, Nocturia, Bladder function, cystometry, polysomnography