Viewing Surface Electrical Stimulation on Pelvic Floor With Ultrasound

Not Applicable

Completed

• Conditions: Pelvic Floor Disorders
• Interventions: Device: Surface electrical stimulation

• Registration Number: NCT03528928
• Lead Sponsor: Elidah, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-17
• Primary Completion: 2018-04-17
• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-05-17
• Study First Posted: 2018-05-18
• Study Completion: 2019-01-21
• Status Verified: 2023-03
• Results First Submitted: 2023-03-04
• Results First Submitted QC: 2024-11-25
• Last Update Submitted: 2024-11-25
• Results First Posted: 2024-12-17
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 8

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?"

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Surface electrical stimulation	Surface electrical stimulation	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.

Primary Outcome Measures

Name	Time	Method
Movement of the Bladder	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.

Trial Locations

Locations (1)

Wome's Health Advantage; 🇺🇸 Fort Wayne, Indiana, United States