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Slow Enrollment
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - OAB with DO+ | Subjects that DO+ nocturia |
| |
| Group 2- OAB with DO- | Subjects that DO- nocturia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cystometry (CMG) | Procedure | recording device measuring pressures though catheters placed in bladder and rectum |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Number of nocturias with urgency ≥3 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects identified through urology physicians, family practice physicians and advertising
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
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| ID | Term |
|---|---|
| D053158 | Nocturia |
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| polysomnography (PSG) | Procedure | Recording device measuring sleep activity through electrodes attached to the subject |
|
| 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 |
| Wake time after sleep onset | 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 |