Viewing Surface Electrical Stimulation on Pelvic Floor With Ultrasound

Study Overview
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Brief Summary
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Subjects will place a surface electrode on their perineal area after a bladder-filling protocol. Transabdominal ultrasound will image the base of the bladder at rest, voluntary pelvic floor contraction, with the surface electrical stimulation and with a combined pelvic floor contraction and electrical stimulation active.

Official Title
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Evaluation of Pelvic Floor Muscle With Surface Electrical Stimulation

Conditions
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Pelvic Floor Disorders

Intervention / Treatment
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* Device: Surface electrical stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age:18-80y Gender: female Exclusion Criteria: Moderate-severe stress incontinence*: As determined by self-reported >3 accidents in 24-hr period Currently pregnant, may be pregnant (Unsure pre and peri-menopausal women should take a pregnancy test.) Active urinary tract infection (UTI) Pelvic pain, Painful bladder syndrome, underlying neurologic/neuromuscular disorder that may impact ability to partake in the trial implanted cardiac device or untreated cardiac arrhythmia Obesity as defined by BMI >= 30 (height, weight recorded) Anyone with impaired decision making, drug or alcohol dependence, or potentially suicidal. Anyone who lacks the capacity to consent for themselves or who requires a legal representative to give informed consent * Stress urinary incontinence: as determined by an answer of Yes to a standard question (from King's Health Questionnaire): Do you lose urine with physical activities such as coughing, sneezing, running?

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Sequential Assignment
Interventional Model Description: Surface electrical stimulation, Elitone by Elidah, Inc.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surface electrical stimulation<br>Each subject did a Kegel pelvic floor contraction, had the surface electrical stimulation turned on at highest comfortable intensity, did a Kegel contraction with surface electrical stimulation on, and had second electrical stimulation turned on. | Device: Surface electrical stimulation<br>* Thin electrode with four conductive areas placed over the perineal area.<br>* Other names: Elitone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement of the bladder | Visualization of movement of the bladder with transabdominal ultrasound | 1 Day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic floor, electrical stimulation, bladder, ultrasound