Stress Incontinence Trial With Elitone Device

Elidah, Inc.

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Device: Transcutaneous electrical stimulation (Elitone)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03782116

0718

Details and patient eligibility

About

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.

Full 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.

Enrollment: 87 patients

Sex: Female

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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87 participants in 2 patient groups

Treatment

Experimental group

Description:

Elitone Surface electrical stimulation with a treatment waveform (medium frequency modulated at 50Hz)

Treatment:

Device: Transcutaneous electrical stimulation (Elitone)

Control

Sham Comparator group

Description:

Elitone Sham surface electrical stimulation at a very low frequency not known to contract muscles.

Treatment:

Device: Transcutaneous electrical stimulation (Elitone)