Viewing Surface Electrical Stimulation on Pelvic Floor With Ultrasound
Not Applicable
Completed
- Conditions
- Pelvic Floor Disorders
- Registration Number
- NCT03528928
- Lead Sponsor
- Elidah, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 8
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?"
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Movement of the Bladder 1 Day Visualization of movement of the bladder with use of device by transabdominal ultrasound was captured and the measurement is measured in pixels for centroid magnitude displacement.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Wome's Health Advantage
🇺🇸Fort Wayne, Indiana, United States
Wome's Health Advantage🇺🇸Fort Wayne, Indiana, United States