Viewing Surface Electrical Stimulation on Pelvic Floor With Ultrasound

Pelvic Floor Disorders Clinical Trial

Official title:

Evaluation of Pelvic Floor Muscle With Surface Electrical Stimulation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03528928
• Other study ID #: 0318
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 17, 2018
• Est. completion date: April 17, 2019

Study information

• Verified date: May 2018
• Source: Elidah, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: April 17, 2019
• Est. primary completion date: April 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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?"

Related Conditions & MeSH terms

• Pelvic Floor Disorders

Intervention

Device:
• Surface electrical stimulation
Thin electrode with four conductive areas placed over the perineal area.

Locations

Country	Name	City	State
United States	Wome's Health Advantage	Fort Wayne	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Elidah, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Movement of the bladder	Visualization of movement of the bladder with transabdominal ultrasound	1 Day