Stress Incontinence Trial With Elitone Device

Randomized Controlled Study of Efficacy of Elitone Device For the Treatment of Mild-Moderate Stress Urinary Incontinence

This is a randomized controlled study in which subjects are assigned to either a treatment group or a control (sham) group. Pre- and post-study outcome measures evaluate the change in incontinence episodes on women with mild-moderate stress urinary incontinence.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: Transcutaneous electrical stimulation (Elitone)

Detailed Description

The Elitone device delivers electrical muscle stimulation to pelvic floor muscles through a disposable surface electrode shaped to fit the perineal region. In typical use women self-administer treatment 20 minutes per day, 5x per week, for 6-12 weeks. Elidah is initiating a prospective, randomized clinical study to demonstrate device efficacy. The study expands a similar pilot to 60 subjects, adds a control arm (sham device) and includes additional outcome measures. Like the earlier study, subjects will self-administer treatment over multiple weeks while maintaining daily logs of their treatment and incontinence symptoms. This is a home-use study, which does not require clinic visits. Accordingly, this allows subject recruitment from across US.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Monroe, Connecticut, United States, 06468
      • Nationwide At-Home study

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Predominant Mild-moderate stress incontinence symptoms as determined by self-reported typical number of accidents of 1 per 24 hours or more.

Exclusion Criteria:

• Severe incontinence as determined by self-reported >5 accidents in 24-hr period
• Currently pregnant, may be pregnant, attempting to become pregnant, or delivery within previous 6 weeks
• Implanted cardiac device, untreated cardiac arrhythmia or suffer from other heart problems.
• Cancer, epilepsy or cognitive dysfunction
• Vaginal or pelvic surgery within previous 6 months
• Complete denervation of the pelvic floor
• History or symptoms of urinary retention, extra-urethral incontinence, overflow incontinence
• Active urinary tract infection (UTI) or history of recurrent UTIs (more than three in a year)
• Recurrent vaginitis (bacterial/fungal)
• Pelvic pain/painful bladder syndrome
• Underlying neurologic/neuromuscular disorder
• Severe Obesity as defined by BMI >= 35
• Chronic coughing
• Impaired decision making, drug or alcohol dependence, or suicidal thoughts.
• Anyone who lacks the capacity to consent for themselves or who requires a legal representative to give informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Elitone Surface electrical stimulation with a treatment waveform (medium frequency modulated at 50Hz)	Device: Transcutaneous electrical stimulation (Elitone); Transcutaneous perineal area electrical stimulation; Other Names: Elitone
Sham Comparator: Control; Elitone Sham surface electrical stimulation at a very low frequency not known to contract muscles.	Device: Transcutaneous electrical stimulation (Elitone); Transcutaneous perineal area electrical stimulation; Other Names: Elitone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Assessed by Percent Reduction in Urinary Incontinence Episodes	The percent reduction in average number of urinary incontinence episodes over 12 weeks.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Assessed by Percent Reduction in Average Pad Weight	The percent reduction of pad weight in a day over the 12 weeks.	12 weeks
Efficacy Assessed by Change in Incontinence Quality of Life Questionnaire (I-QOL)	The efficacy assessed by change in Incontinence quality of life questionnaire (I-QOL). It comprises 22 questions, to which the subject provides a numeric response on a 1-5 scale. 1 = not at all , 2 = a little, 3 = moderately, 4 = quite a bit and 5 = extremely. The score is the sum of the numeric responses, which can range from 22 to 110. The lower the value the less times it happens and the better outcome.	12 weeks
Pads Per Day	Reduction of number of pads used per day	12 weeks

Collaborators and Investigators

• Sponsor: Elidah, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: December 19, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 0718

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