Viewing Surface Electrical Stimulation on Pelvic Floor With Ultrasound

November 25, 2024 updated by: Elidah, Inc.

Evaluation of Pelvic Floor Muscle With Surface Electrical Stimulation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • Wome's Health Advantage

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Surface electrical stimulation
Thin electrode with four conductive areas placed over the perineal area.
Other Names:
  • Elitone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elidah, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2018

Primary Completion (Actual)

April 17, 2018

Study Completion (Actual)

January 21, 2019

Study Registration Dates

First Submitted

May 7, 2018

First Submitted That Met QC Criteria

May 17, 2018

First Posted (Actual)

May 18, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0318

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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