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| Name | Class |
|---|---|
| Princeton Urogynecology | OTHER |
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Urinary incontinence (UI) and overactive bladder (OAB) in women has high prevalence which is increasing with the age. In adults aged 40 and older in the US demonstrated prevalence rate of 27.2% among man and 43.1% among women, respectively. Urine Incontinence was reported to affect 15% of women ages 40 to 49, 25% ages 60 to 69, and 38% of women age 80 and older.
Pelvic floor disorders result from neuro-urinary pathology as well as muscle functional impairment due to changes in bio-mechanical properties of soft tissues with the age. That is why pelvic floor characterization and diagnosis must include electomyographic (EMG) and biomechanical measurements (pressure) or better if EMG and tactile imaging with improved spatial resolution. The quantitative and objective imaging data for pelvic floor conditions could allow an effective treatment of OAB and UI.
In this research the investigators propose to develop a new device for accurate diagnosis of the diseased conditions by measuring the pelvic floor muscles strength and EMG activity. The value to society is high given by the prevalence of OAB and UI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal | No UI, no OAB conditions. Transvaginal biomechanical and electromyography mapping will be completed. |
| |
| Urinary incontinence | Urinary incontinence conditions. Transvaginal biomechanical and electromyography mapping will be completed. |
| |
| Overactive bladder | Overactive bladder conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomechanical and electromyography mapping | Diagnostic Test | The vaginal tactile imaging probe will acquire biomechanical and electromyography high definition measurements for anterior and posterior compartments along entire vagina. |
| Measure | Description | Time Frame |
|---|---|---|
| Transvaginal biomechanical maps | Transvaginal biomechanical maps (pressures in Pa) will be recorded and compared for UI and OAB versus normal conditions. | Four months |
| Transvaginal electromyography maps | Transvaginal electromyography maps (electrical voltages in mV) will be recorded and compared for UI and OAB versus normal conditions. | Four months |
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Inclusion Criteria:
Exclusion Criteria:
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There is no inclusion or exclusion criteria based on ethnic background, religion, or other division of population other than these stated in Exclusion Criteria section.
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| Name | Affiliation | Role |
|---|---|---|
| Heather van Raalte, MD | Princeton Urogynecology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princeton Urogynecology | Princeton | New Jersey | 08540 | United States | ||
| Institute of Female Pelvic Medicine & Reconstructive Surgery (IFPM) |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Allentown |
| Pennsylvania |
| 18103 |
| United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |