An interventional study of Surface electrode in Stress Urinary Incontinence and Urinary Incontinence, sponsored by Elidah, Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Elidah, Inc. · Not applicable, Interventional, and Treatment
This study evaluates surface electrical muscle stimulation for women with incontinence symptoms. Phase I is a single-session study to test usability, comfort and tolerability at various waveforms. Phase II is a six-week at-home study to test compliance and efficacy.
Urinary incontinence (UI) is a widely prevalent condition affecting approximately 1 in 3 women over the age of 30. Non-surgical strengthening of the pelvic floor muscles has proven effective in treating most stress urinary incontinence (SUI), however, low compliance of exercises and low adoption of intravaginal devices leads to a need for adoptable non-surgical treatments. Building on recent clinical reports that a pattern of surface electrodes are as effective as intravaginal electrodes at retraining the pelvic floor muscles, this study evaluates a new surface electrode at various waveforms.
In Phase I, patients would receive the Elidah device and generators with settings of low frequency stimulation (similar to intravaginal waveforms), modulated sine-wave medium frequency or medium frequency Burst-Mode Alternating Current (Russian).
In Phase II, patients would receive the Elidah device with the most promising waveforms from Phase I for a six-week at-home study.
651 studies on the registry are indexed under Urinary Incontinence, Stress; 120 are open to participants now.
This study's enrollment of 23 is below the median of 68 across 506 interventional studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →Elidah, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In Phase II, the patient will receive the Elidah surface electrodes, and a waveform determined in Phase I on the generator.
Device: Surface electrode
Transcutaneous electrical stimulation with various waveforms
Also known as: Elidah device
Questionnaire on comfort and tolerability
Phase I: single sitting
Time frame: 8 weeks
Accidents per week based on daily log and questionnaire
Phase II: six-week at-home usage
Time frame: 8 months
Pad usage based on questionnaire
Phase II: six-week at-home usage
Time frame: 8 months
Incontinence Quality of Life Questionnaire (I-QOL)
Phase II: six-week at-home usage
Time frame: 8 months
Max Intensity Level improvement based on daily log
Phase II: six week at-home usage
Time frame: 8 months
Visual evaluation of usability of device with written Instructions For Use
Phase I: single sitting
Time frame: 8 weeks
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Dec 2016, a primary completion of Aug 2018 and a completion of Aug 2018. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Urinary Incontinence, Stress →
Elidah, Inc.