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

Astellas Pharma Inc15 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Bladder Function

Interventions

cystometry (CMG)PROCEDURE

recording device measuring pressures though catheters placed in bladder and rectum

polysomnography (PSG)PROCEDURE

Recording device measuring sleep activity through electrodes attached to the subject

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States