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Shocking the bladder into behaving: new implant shows promise

NCT ID NCT03556891

Symptom relief 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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a small device called eCoin that is implanted under the skin near the ankle to stimulate a nerve that controls the bladder. The goal was to see if it could reduce urgent, frequent urination and accidental leaks in people with overactive bladder. 133 adults who had not gotten enough help from medications took part. The main measure was whether their number of leaking episodes dropped 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 it works, this could offer a long-term, drug-free option for people with overactive bladder who haven't found relief from medications.
What could go wrong
This is a single-arm study with no placebo group, so results may be less reliable. The device requires a minor surgical implant, which carries risks like infection or discomfort.

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

133 people

The number who actually took part.

Started

Sep 2018

Finished

Sep 2024

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 to 80 years

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.

Primary Inclusion Criteria: 1. Women and men between 18 and 80 years old. 2. Diagnosis of overactive bladder with urgency urinary incontinence or mixed urge and stress incontinence with a predominant urgency component (selfreported), for at least 6 months. 3. Individual is without pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists). 4. Individual is intolerant of or has an inadequate response to any of anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or percutaneous tibial nerve stimulation. Primary Exclusion Criteria: 1. Predominant stress urinary incontinence with more than 1/3 stress urinary incontinent episodes when compared to total urinary incontinent episodes. 2. Clinically significant bladder outlet obstruction. 3. Clinically significant pelvic organ prolapse beyond the hymenal ring. 4. Inadequate skin integrity or any evidence of an infection or inflammation in either lower leg.

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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

Contacts and locations

Locations

  • Adult & Pediatric Urology

    Omaha, Nebraska, 68114, United States

  • Alliance Urology Specialists

    Greensboro, North Carolina, 27403, United States

  • Chesapeake Urology

    Owings Mills, Maryland, 21117, United States

  • Florida Bladder Institute

    Naples, Florida, 34109, United States

  • Kaiser Permanente

    Downey, California, 90242, United States

  • Kaiser Permanente

    San Diego, California, 92110, United States

  • Manhattan Medical Research

    New York, New York, 10016, United States

  • North Shore Medical Group

    Skokie, Illinois, 60076, United States

  • Sansum Clinic

    Santa Barbara, California, 93105, United States

  • Sequoia Urology Center

    Redwood City, California, 94062, United States

  • South Carolina OB/GYN

    Columbia, South Carolina, 29201, United States

  • SurgOne PC

    Englewood, Colorado, 80113, United States

  • The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute)

    Allentown, Pennsylvania, 18103, United States

  • UnityPoint Clinic

    Waterloo, Iowa, 50703, United States

  • Urology Associates of Norwalk

    Norwalk, Connecticut, 06850, United States

More trials for these conditions

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