Tactile Imaging and Electromyography

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Tactile Imaging and Electromyography of Female Pelvic Floor

Conditions
-----------------
Urinary Incontinence, Overactive Bladder

Intervention / Treatment
-----------------
* Diagnostic Test: Biomechanical and electromyography mapping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women above age of 21 with normal pelvic floor condition for the control Women with SUI conditions as defined by International Continence Society guidelines Women with OAB conditions as defined by American Urological Association and Society of Urodinamics, Female Pelvic Medicine & Urogenital Reconstruction. Exclusion Criteria: Any prior pelvic floor surgery related to SUI, POP or OAB conditions Active skin infection or ulceration within the vagina Presence of the vaginal septum Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder Ongoing radiation therapy for pelvic cancer; impacted stool Surgically absent rectum or bladder Sever hemorrhoids Significant circulatory or cardiac conditions that could cause excessive risk Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvodynia.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
Female

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal<br>No UI, no OAB conditions. Transvaginal biomechanical and electromyography mapping will be completed. | Diagnostic Test: Biomechanical and electromyography mapping<br>* The vaginal tactile imaging probe will acquire biomechanical and electromyography high definition measurements for anterior and posterior compartments along entire vagina.<br>|
| Urinary incontinence<br>Urinary incontinence conditions. Transvaginal biomechanical and electromyography mapping will be completed. | Diagnostic Test: Biomechanical and electromyography mapping<br>* The vaginal tactile imaging probe will acquire biomechanical and electromyography high definition measurements for anterior and posterior compartments along entire vagina.<br>|
| Overactive bladder<br>Overactive bladder conditions | Diagnostic Test: Biomechanical and electromyography mapping<br>* The vaginal tactile imaging probe will acquire biomechanical and electromyography high definition measurements for anterior and posterior compartments along entire vagina.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 |