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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-07-31

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.

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Detailed Description

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Conditions

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Bladder Function

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1 -OAB

Subjects with overactive bladder (OAB)

cystometry

Intervention Type PROCEDURE

recording device measuring pressures though catheters placed in bladder and rectum

polysomnography

Intervention Type PROCEDURE

recording device measuring sleep activity through electrodes attached to the subject

Group 2 - Insomnia

Subjects with insomnia

cystometry

Intervention Type PROCEDURE

recording device measuring pressures though catheters placed in bladder and rectum

polysomnography

Intervention Type PROCEDURE

recording device measuring sleep activity through electrodes attached to the subject

Group 3 - Normal

Normal Subjects

cystometry

Intervention Type PROCEDURE

recording device measuring pressures though catheters placed in bladder and rectum

polysomnography

Intervention Type PROCEDURE

recording device measuring sleep activity through electrodes attached to the subject

Interventions

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cystometry

recording device measuring pressures though catheters placed in bladder and rectum

Intervention Type PROCEDURE

polysomnography

recording device measuring sleep activity through electrodes attached to the subject

Intervention Type PROCEDURE

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