Pilot Trial in Sleep Laboratory Setting to Compare the Physiology of Night Time Bladder Function in Subjects With Overactive Bladder (OAB) Versus Subjects That Have Insomnia and Healthy Normal Subjects

Study Overview
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Brief Summary
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This is an observational, physiology pilot study of subjects with overactive bladder, insomnia and normal subjects. No study drug will be given. All subjects will complete a one week sleep diary and a 3-day bladder diary. After one week, subjects meeting eligibility requirements will complete a single sleep night stay in a sleep laboratory setting. During the sleep night stay, subjects will be evaluated using cystometry and polysomnography. In the morning following the sleep night stay, subjects will complete a sleep questionnaire and this will complete their participation in the study.

Official Title
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A Pilot, Phase 4, Sleep Laboratory Study Comparing the Physiology of Nocturnal Bladder Function in Subjects With Overactive Bladder - Associated Nocturia to Subjects With Primary Insomnia and Healthy Normal Subjects

Conditions
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Bladder Function

Intervention / Treatment
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* Procedure: cystometry
* Procedure: polysomnography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must not have a urinary tract infection Time in bed between 6.5 and 9 hours for at least 5 nights per week for preceding month Usual bed time is before midnight (24:00 hours) and typically does not vary by ± 1 hour for preceding month OAB subjects OAB symptoms for >= 3 months Documented detrusor overactivity episodes within 6 months Insomnia subjects Diagnosis of chronic primary insomnia History of > 1 month of waking up more than 2 times per night and being awake for more than 60 minutes per night for at least 3 months Exclusion Criteria: Diagnosis of both OAB and primary insomnia Diagnosis of nocturnal polyuria Diagnosis of BPH BMI >= 34

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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<br>Subjects with overactive bladder (OAB) | Procedure: cystometry<br>* recording device measuring pressures though catheters placed in bladder and rectum<br>Procedure: polysomnography<br>* recording device measuring sleep activity through electrodes attached to the subject<br>|
| Group 2 - Insomnia<br>Subjects with insomnia | Procedure: cystometry<br>* recording device measuring pressures though catheters placed in bladder and rectum<br>Procedure: polysomnography<br>* recording device measuring sleep activity through electrodes attached to the subject<br>|
| Group 3 - Normal<br>Normal Subjects | Procedure: cystometry<br>* recording device measuring pressures though catheters placed in bladder and rectum<br>Procedure: polysomnography<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 |
| --- | --- | --- |
| Number and proportion of voids associated with urgency |  | During night in sleep lab | 
| Number and proportion of voids associated with Detrusor Overactivity episodes within 10 minutes prior to the polysomnography (PSG) awakenings |  | During night in sleep lab | 
| Time from PSG awakening to each void in minutes |  | 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, Insomnia, Bladder function, cystometry, polysomnography