Bladder Function
Conditions
Keywords
OAB, Nocturia, Bladder function, cystometry, polysomnography
Brief summary
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.
Interventions
PROCEDUREcystometry (CMG)
recording device measuring pressures though catheters placed in bladder and rectum
PROCEDUREpolysomnography (PSG)
Recording device measuring sleep activity through electrodes attached to the subject
Sponsors
Astellas Pharma Inc
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average nocturia individual volume void | During night in sleep lab |
| Nocturnal functional bladder capacity | During night in sleep lab |
| Total urine production | During night in sleep lab |
Secondary
| Measure | Time frame |
|---|---|
| Number of nocturias with urgency ≥3 | During night in sleep lab |
| Percentage of subjects with ≥ 2 nocturias | During night in sleep lab |
| Time from awakening to void on CMG/PSG | During night in sleep lab |
| Number of awakenings | During night in sleep lab |
| Sleep onset latency | During night in sleep lab |
| For DO+ subjects, number of nocturias associated with DO+ | During night in sleep lab |
| Wake time after sleep onset | During night in sleep lab |
| Total wake time from lights out until getting out of bed in the morning | During night in sleep lab |
| Average urgency rating | During night in sleep lab |
Countries
United States
Outcome results
None listed