Pelvic Floor Disorders
Conditions
Keywords
pelvic floor, electrical stimulation, bladder, ultrasound
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.
Interventions
Thin electrode with four conductive areas placed over the perineal area.
Sponsors
Elidah, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Masking description
The patient was not allowed to see the ultrasound screen
Intervention model description
Surface electrical stimulation, Elitone by Elidah, Inc.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
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?
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Surface Electrical Stimulation 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.
Surface electrical stimulation: Thin electrode with four conductive areas placed over the perineal area. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Surface Electrical Stimulation | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 8 Participants | — |
| Age, Continuous | 37.5 years STANDARD_DEVIATION 8.8 | — |
| BMI | 24.9 lbs/ in^2 STANDARD_DEVIATION 4.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 8 Participants | — |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Movement of the Bladder
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.
Time frame: 1 Day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Surface Electrical Stimulation | Movement of the Bladder | 23.1 pixels | Standard Deviation 11.7 |