Viewing Surface Electrical Stimulation on Pelvic Floor With Ultrasound

NCT03528928 | Completed Results FDA Device

• 1 other identifier: 0318
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Disorders

Keywords

pelvic floor; electrical stimulation; bladder; ultrasound

Outcome Measures

Primary Outcomes (1)

• Movement of the Bladder

  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.

  1 Day

Study Arms (1)

Surface electrical stimulation

EXPERIMENTAL

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.

Device: Surface electrical stimulation

Interventions

Surface electrical stimulation DEVICE

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

Also known as: Elitone

Surface electrical stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age:18-80y
• Gender: female

You may not qualify if:

• 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?"

Sponsors & Collaborators

• Elidah, Inc.: lead

Study Sites (1)

Wome's Health Advantage

Fort Wayne, Indiana, 46825, United States

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Results Point of Contact

• Title: Teresa Brousseau
• Organization: Womens Health

tbrousseau@isapin.com

866-432-4400

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The patient was not allowed to see the ultrasound screen
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Surface electrical stimulation, Elitone by Elidah, Inc.

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: May 18, 2018
• Study Start: April 17, 2018
• Primary Completion: April 17, 2018
• Study Completion: January 21, 2019
• Last Updated: December 17, 2024
• Results First Posted: December 17, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)