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

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

TERMINATED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-05-31

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.

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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 with DO+

Subjects that DO+ nocturia

cystometry (CMG)

Intervention Type PROCEDURE

recording device measuring pressures though catheters placed in bladder and rectum

polysomnography (PSG)

Intervention Type PROCEDURE

Recording device measuring sleep activity through electrodes attached to the subject

Group 2- OAB with DO-

Subjects that DO- nocturia

cystometry (CMG)

Intervention Type PROCEDURE

recording device measuring pressures though catheters placed in bladder and rectum

polysomnography (PSG)

Intervention Type PROCEDURE

Recording device measuring sleep activity through electrodes attached to the subject

Interventions

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cystometry (CMG)

recording device measuring pressures though catheters placed in bladder and rectum

Intervention Type PROCEDURE

polysomnography (PSG)

Recording device measuring sleep activity through electrodes attached to the subject

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No