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

Astellas

Status

Terminated

Conditions

Bladder Function

Treatments

Procedure: cystometry (CMG)

Procedure: polysomnography (PSG)

Study type

Observational

Funder types

Industry

Identifiers

NCT01099345

905-UC-040

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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