Viewing Surface Electrical Stimulation on Pelvic Floor With Ultrasound

Elidah, Inc.

Status: Completed

Conditions: Pelvic Floor Disorders

Treatments: Device: Surface electrical stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03528928

0318

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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?"

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Surface electrical stimulation

Experimental group

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.

Treatment:

Device: Surface electrical stimulation