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OpenTrials
Completed

NCT Number: NCT03528928

Viewing Surface Electrical Stimulation on Pelvic Floor With Ultrasound

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.

Completed

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Key information

Conditions

Pelvic Floor Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wome's Health Advantage

Fort Wayne, Indiana, 46825, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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?"

Treatment and study plan

Surface electrical stimulation

Device

Thin electrode with four conductive areas placed over the perineal area.

Other names: Elitone

Primary outcomes

  1. Movement of the Bladder

    Time frame: 1 Day

    Visualization of movement of the bladder with use of device by transabdominal ultrasound was captured and the measurement is measured in pixels for centroid magnitude displacement.

Sponsors and collaborators

Lead sponsor

Elidah, Inc.

Industry

Registry information

Official study title

Evaluation of Pelvic Floor Muscle With Surface Electrical Stimulation

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
May 18, 2018
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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