Back to resultsViewing Surface Electrical Stimulation on Pelvic Floor With Ultrasound
Primary Purpose
Pelvic Floor Disorders
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surface electrical stimulation
Sponsored by
About this trial
This is an interventional other trial for Pelvic Floor Disorders focused on measuring pelvic floor, electrical stimulation, bladder, ultrasound
Eligibility Criteria
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?"
Sites / Locations
- Wome's Health Advantage
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Surface electrical stimulation
Arm Description
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.
Outcomes
Primary Outcome Measures
Movement of the bladder
Visualization of movement of the bladder with transabdominal ultrasound
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03528928
Brief Title
Viewing Surface Electrical Stimulation on Pelvic Floor With Ultrasound
Official Title
Evaluation of Pelvic Floor Muscle With Surface Electrical Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
April 17, 2018 (Actual)
Study Completion Date
April 17, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elidah, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders
Keywords
pelvic floor, electrical stimulation, bladder, ultrasound
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Surface electrical stimulation, Elitone by Elidah, Inc.
Masking
None (Open Label)
Masking Description
The patient was not allowed to see the ultrasound screen
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surface electrical stimulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Surface electrical stimulation
Other Intervention Name(s)
Elitone
Intervention Description
Thin electrode with four conductive areas placed over the perineal area.
Primary Outcome Measure Information:
Title
Movement of the bladder
Description
Visualization of movement of the bladder with transabdominal ultrasound
Time Frame
1 Day
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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?"
Facility Information:
Facility Name
Wome's Health Advantage
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Viewing Surface Electrical Stimulation on Pelvic Floor With Ultrasound
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