Coin-Sized implant zaps nerves to curb urgent bathroom trips

NCT ID NCT05882318

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a coin-sized device called eCoin that is implanted near the ankle to stimulate a nerve and reduce urgent bathroom trips in people with overactive bladder. 38 adults who had not gotten enough relief from other treatments were randomly assigned to receive either a strong or mild stimulation. The main goal was to see how many fewer urgent leaks they had per day after 3 months.

What this could mean

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

Active substance
eCoin Peripheral Neurostimulator System (implanted device)
What this could lead to
If it works, this could offer a new, low-maintenance option for people with overactive bladder who haven't found relief from other treatments.
What could go wrong
This is a small, early-stage study with only 38 participants. The device requires surgery, and it's not yet clear if the benefit is large enough to outweigh the risks of implantation.

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

38 people

The number who actually took part.

Started

Jun 2023

Finished

May 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 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.

Key Inclusion Criteria: 1. Individual with diagnosis of overactive bladder with urgency urinary incontinence - daily UUI with a predominantly urgency component 2. 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). 3. Individual is determined to be a suitable surgical candidate by physician. Key Exclusion Criteria: 1. Individual is not appropriate for eCoin therapy based upon the US FDA-approved IFU requirements. 2. Individual has predominantly stress urinary incontinence (greater than 1/3 of leaks on baseline diary are stress). 3. Individual has clinically significant bladder outlet obstruction. 4. Individual has an active urinary tract infection at time of enrollment or has had four or more symptomatic UTI's in the last 12 months. 5. Individual has significant lower urinary tract pain or has been diagnosed with interstitial cystitis or bladder pain syndrome that is actively being managed. 6. Individual has post void residual greater than 200 cc. 7. Individual has an active diagnosis of bladder, urethral, or prostate cancer. 8. Individual has had a prior anti-stress incontinence surgery within the last year. 9. Individual has uncontrolled diabetes mellitus (Hemoglobin A1C\>7). 10. Individual is neutropenic or immune-compromised. 11. Individual has lower extremity pathology such as: 1. Previous surgery and/or significant scarring at the planned implant location 2. Ongoing dermatologic condition at the implant site, including but not limited to dermatitis and autoimmune disorders 3. Clinically significant peripheral neuropathy in the lower extremities 4. Pitting edema at the implant location (≥ 2+ is excluded) 5. Inadequate skin integrity or any evidence of an infection or inflammation in either lower leg 6. Moderate to severe varicose veins 7. Open wounds or recent trauma 8. Arterial and/or vasculitis disease in the lower extremities 9. Chronic venous insufficiency with a history of skin change (hyperpigmentation, lipodermatosclerosis, ulceration) in the ankle region 12. Individual has neurogenic bladder dysfunction. 13. Individual is aware that he or she will need an MRI scan other than a head/neck/shoulder MRI during the study period. 14. Any condition that, in the investigator's opinion, would preclude participation in the study (e.g., comorbidity that places subject at increased risk for surgical intervention, medical condition that may increase the risk associated with study participation or may interfere with interpretation of study results, inability to adhere to the visit schedule, such as morbid obesity, clotting or bleeding disorder)

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Conditions

The condition(s) this trial relates to.

Urinary Incontinence, Urge

As listed by the trial registrant

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

Contacts and locations

Locations

  • Adult & Pediatric Urology P.C.

    Omaha, Nebraska, 68114, United States

  • Associated Urologists of North Carolina

    Raleigh, North Carolina, 27612, United States

  • Cypress Medical Research Center

    Wichita, Kansas, 67226, United States

  • Genesis Research

    Downey, California, 90241, United States

  • Institute for Female Pelvic Medicine

    Allentown, Pennsylvania, 18103, United States

  • The Iowa Clinic

    Ankeny, Iowa, 50023, United States

  • Urology Associates of Central California

    Fresno, California, 93720, United States

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