Stress Incontinence Trial With Elitone Device

Elidah, Inc.87 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Stress Urinary Incontinence

Interventions

Transcutaneous electrical stimulation (Elitone)DEVICE

Transcutaneous perineal area electrical stimulation

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Nationwide At-Home study

Monroe, Connecticut, United States

Outcomes

Primary Outcomes

Efficacy Assessed by Percent Reduction in Urinary Incontinence Episodes

The percent reduction in average number of urinary incontinence episodes over 12 weeks.

Time frame: 12 weeks

Secondary Outcomes

Efficacy Assessed by Percent Reduction in Average Pad Weight

The percent reduction of pad weight in a day over the 12 weeks.

Time frame: 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.

Time frame: 12 weeks

Pads Per Day

Reduction of number of pads used per day

Time frame: 12 weeks

Data from ClinicalTrials.gov

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