Stress Incontinence Trial With Elitone Device

NCT ID: NCT03782116

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2019-03-31

Brief Summary

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.

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.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

Transcutaneous electrical stimulation (Elitone)

Intervention Type: DEVICE

Transcutaneous perineal area electrical stimulation

Control

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

Group Type: SHAM_COMPARATOR

Transcutaneous electrical stimulation (Elitone)

Intervention Type: DEVICE

Transcutaneous perineal area electrical stimulation

Interventions

Transcutaneous electrical stimulation (Elitone)

Transcutaneous perineal area electrical stimulation

Intervention Type: DEVICE

Other Intervention Names

Elitone

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Elidah, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nationwide At-Home study

Monroe, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

0718

Identifier Type: -

Identifier Source: org_study_id