Trial Outcomes & Findings for Viewing Surface Electrical Stimulation on Pelvic Floor With Ultrasound (NCT NCT03528928)
NCT ID: NCT03528928
Last Updated: 2024-12-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
1 Day
Results posted on
2024-12-17
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Surface Electrical Stimulation
n=8 Participants
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.
|
|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
37.5 years
STANDARD_DEVIATION 8.8 • n=8 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
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8 Participants
n=8 Participants
|
|
BMI
|
24.9 lbs/ in^2
STANDARD_DEVIATION 4.3 • n=8 Participants
|
PRIMARY outcome
Timeframe: 1 DayVisualization 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.
Outcome measures
| Measure |
Surface Electrical Stimulation
n=8 Participants
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.
|
|---|---|
|
Movement of the Bladder
|
23.1 pixels
Standard Deviation 11.7
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Adverse Events
Surface Electrical Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place