Viewing Surface Electrical Stimulation on Pelvic Floor With Ultrasound

E

Elidah, Inc.

Status

Active, not recruiting

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

12 estimated 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

12 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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