Viewing Surface Electrical Stimulation on Pelvic Floor With Ultrasound
NCT ID: NCT03528928
Last Updated: 2024-12-17
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
8 participants
INTERVENTIONAL
2018-04-17
2019-01-21
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SEQUENTIAL
OTHER
NONE
Study Groups
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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.
Interventions
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Surface electrical stimulation
Thin electrode with four conductive areas placed over the perineal area.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Gender: female
Exclusion Criteria
* 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?"
18 Years
80 Years
FEMALE
Yes
Sponsors
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Elidah, Inc.
INDUSTRY
Responsible Party
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Locations
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Wome's Health Advantage
Fort Wayne, Indiana, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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0318
Identifier Type: -
Identifier Source: org_study_id