Stress Urinary IncontinenceNCT03782116
Stress Incontinence Trial With Elitone Device
A study testing Transcutaneous electrical stimulation (Elitone) in people with Stress Urinary Incontinence, run by Elidah, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Transcutaneous electrical stimulation (Elitone)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Predominant Mild-moderate stress incontinence symptoms as determined by self-reported typical number of accidents of 1 per 24 hours or more.
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Transcutaneous electrical stimulation (Elitone)
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical stimulation (Elitone)Device
Also called Elitone
Transcutaneous perineal area electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Elitone Surface electrical stimulation with a treatment waveform (medium frequency modulated at 50Hz) Receives: Device: Transcutaneous electrical stimulation (Elitone) |
| Control | Sham comparator | Elitone Sham surface electrical stimulation at a very low frequency not known to contract muscles. Receives: Device: Transcutaneous electrical stimulation (Elitone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Assessed by Percent Reduction in Urinary Incontinence Episodes
The percent reduction in average number of urinary incontinence episodes over 12 weeks.
Measured: 12 weeks
Secondary outcomes (3)
Efficacy Assessed by Percent Reduction in Average Pad Weight
The percent reduction of pad weight in a day over the 12 weeks.
Measured: 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.
Measured: 12 weeks
Pads Per Day
Reduction of number of pads used per day
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start1 Sep 2018
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elidah, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782116
- Sponsor's protocol ID
- 0718
- Status last verified
- Jan 2025
- First submitted
- 16 Aug 2018
- Last updated
- 13 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of Efficacy of Elitone Device For the Treatment of Mild-Moderate Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03782116
- Acronym / sponsor ID
- 0718
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Elidah, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Posted 13 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Transcutaneous electrical stimulation (Elitone)Elitone Surface electrical stimulation with a treatment waveform (medium frequency modulated at 50Hz) |
| Control | Sham comparator | Device: Transcutaneous electrical stimulation (Elitone)Elitone Sham surface electrical stimulation at a very low frequency not known to contract muscles. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Predominant Mild-moderate stress incontinence symptoms as determined by self-reported typical number of accidents of 1 per 24 hours or more.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical stimulation (Elitone)Also: ElitoneTranscutaneous perineal area electrical stimulation | Device | Control, Treatment |
Primary outcome
Efficacy Assessed by Percent Reduction in Urinary Incontinence Episodes
Time frame: 12 weeks
The percent reduction in average number of urinary incontinence episodes over 12 weeks.
3 secondary outcomes
Efficacy Assessed by Percent Reduction in Average Pad Weight
Time frame: 12 weeks
Efficacy Assessed by Change in Incontinence Quality of Life Questionnaire (I-QOL)
Time frame: 12 weeks
Pads Per Day
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical stimulation (Elitone) in people with Stress Urinary Incontinence, run by Elidah, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Assessed by Percent Reduction in Urinary Incontinence Episodes (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.