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New implanted device aims to stop urgency incontinence

NCT ID NCT05685433

Disease control Sponsor: Valencia Technologies Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a small device called eCoin that is implanted under the skin to stimulate a nerve in the leg. The goal is to reduce sudden, strong urges to urinate that lead to leaks. Researchers will track 200 adults with overactive bladder to see if the device safely cuts leakage episodes by at least half.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
eCoin tibial nerve stimulation device
What this could lead to
If successful, this could offer a long-term, implanted option to reduce sudden urine leaks for people with overactive bladder.
What could go wrong
This is a single-arm, post-approval study, so there is no comparison group. The device requires a minor surgical implant, and risks include infection or device-related side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Women and men above 18 years old with gender percentages reflective of disease prevalence in the U.S. population * Individual with diagnosis of overactive bladder with urgency urinary incontinence. * Individual has at least one urgency urinary incontinence episode on each of three days as determined on a 3-day voiding diary. * Individual gives written informed consent. * Individual is mentally competent and able to understand all study requirements. * Individual is willing and able to complete a 3-day voiding diary and quality of life questionnaire. * Individual is without pharmacological treatment of overactive bladder (anticholinergic and β3-adrenoceptor agonists) for 2 weeks prior to baseline or longer if the physician judges that the therapeutic effect is still present. * Individual is intolerant of or has an inadequate response to any of anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or who have undergone percutaneous tibial nerve stimulation (PTNS). * Individual is determined to be a suitable surgical candidate by physician. * Individual is appropriate for eCoin treatment based on the US FDA-approved IFU requirements. Exclusion Criteria: * Individual is not appropriate for eCoin therapy based upon the US FDA-approved IFU requirements. * Individual has clinically significant bladder outlet obstruction. (Suspected bladder outlet obstruction will be initially assessed by uroflow study with those having a maximum flow rate \< 15mL/s requiring additional evaluation.) * Individual has predominantly stress urinary incontinence (greater than 1/3 of leaks on baseline diary are stress). * Individual has an active urinary tract infection at time of enrollment. * Individual has known polyuria. * Individual has significant lower urinary tract pain or has been diagnosed with interstitial cystitis or bladder pain syndrome. * Individual has abnormal post void residual (i.e. greater than 200 cc initially and on repeat testing after double voiding) * Individual has clinically significant urethral stricture disease or bladder neck contracture. (Suspected disease or contracture will be initially assessed by uroflow study with those having a maximum flow rate \< 15mL/s requiring additional evaluation.) * Individual has chronic venous insufficiency with a history of skin change (hyperpigmentation, lipodermatosclerosis, ulceration) in the ankle region. * Individual has morbid obesity and in the opinion of the investigator is not a good candidate for the study. * Individual has had diagnosis of bladder, urethral, or prostate cancer. * Individual has had a prior anti-stress incontinence sling surgery within the last year. * Individual is pregnant or intends to become pregnant during the study. * Individual has the presence of urinary fistula, bladder stone, or interstitial cystitis. * Individual has uncontrolled diabetes mellitus (Hemoglobin A1C\>7) or diabetes with significant peripheral complications. (Uncontrolled diabetes will be ruled out by blood test excluding those with Hemoglobin A1C\>7). * Individual has an implantable neurostimulator, pacemaker, or implantable cardiac defibrillator (ICD). * Individual has been treated with onabotulinumtoxinA in the previous 9 months prior to enrollment, or more time if the principal investigator judges that the therapeutic effect is present. * Individual has been treated with percutaneous tibial nerve stimulation (PTNS) within the previous 4 weeks prior to enrollment or more time if the principal investigator judges that the therapeutic effect is present. * Individual is currently using transcutaneous electrical nerve stimulation (TENS) in the pelvic region, back, or legs. * Individual is aware that he or she will need an MRI scan other than a head/neck/shoulder MRI during the study period. * Individual has a clotting or bleeding disorder or is using anticoagulant therapies and in the opinion of the investigator is not a good candidate for the study (antiplatelet and anticoagulant therapy may be continued or held at the discretion of the investigator). * Individual is neutropenic or immune-compromised. * Individual has had previous surgery and/or significant scarring at the implant location. * Individual has ongoing dermatologic condition at the implant site, including but not limited to dermatitis and autoimmune disorders. * Individual has a clinically significant peripheral neuropathy in the lower extremities. * Individual has neurogenic bladder dysfunction. * Individual has pitting edema at implant location (≥ 2+ is excluded). * Individual has inadequate skin integrity or any evidence of an infection or inflammation in either lower leg. * Individual has varicose veins and is symptomatic. * Individual has open wounds, trauma, or prior surgery in the lower extremities. * Individual has arterial disease in the lower extremities. * Individual has vasculitis in the lower extremities. * Individual has bladder stones or neoplasia. (Suspected bladder stones or neoplasia will be ruled out with a urine dipstick showing no more than trace blood, and microscopic analysis (which should be done in that case) shows ≥3 PBC's /HPF unless that subject has been worked up and found negative for clinically significant disease such as malignant neoplasm or stones.) * In the opinion of the investigator, Individual is not a good candidate for participation in the study.

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Conditions

The condition(s) this trial relates to.

overactive bladder Urinary Incontinence Urinary Incontinence, Urge

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Incontinence, urinary Overactive bladder Urge incontinence Urinary urge incontinence

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AIR Research

    RECRUITING

    Los Angeles, California, 90017, United States

  • Arkansas Urology

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Cypress Medical Research

    RECRUITING

    Wichita, Kansas, 67226, United States

  • Louisiana State University Health Sciences Center

    ACTIVE_NOT_RECRUITING

    Shreveport, Louisiana, 71103, United States

  • Minnesota Urology

    RECRUITING

    Woodbury, Minnesota, 55125, United States

  • Rush University

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Southern Urogynecology

    RECRUITING

    West Columbia, South Carolina, 29169, United States

  • Specialty Clinical Research of St. Louis

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Stanford Health

    RECRUITING

    Stanford, California, 94305, United States

  • The Emory Clinic

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • The Iowa Clinic

    RECRUITING

    Ankeny, Iowa, 50023, United States

  • The Methodist Hospital Research Institute

    RECRUITING

    Houston, Texas, 77030, United States

  • The Oregon Clinic

    ACTIVE_NOT_RECRUITING

    Portland, Oregon, 97225, United States

  • UPNT Research Institute

    RECRUITING

    Arlington, Texas, 76017, United States

  • USA Health

    WITHDRAWN

    Mobile, Alabama, 36606, United States

  • University of California, Irvine

    RECRUITING

    Irvine, California, 92697, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Kansas Medical Center Research Institute, Inc

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • Urological Research Network Corp

    RECRUITING

    Hialeah, Florida, 33016, United States

  • Urology Centers of Alabama

    RECRUITING

    Homewood, Alabama, 35209, United States

  • Weill Cornell Medicine: Department of Urology

    RECRUITING

    New York, New York, 10065, United States

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