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Tiny implant zaps bladder nerves to curb leaks

NCT ID NCT03596671

Symptom relief Sponsor: BlueWind Medical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a small implantable device that stimulates a nerve in the leg to help control overactive bladder symptoms. 282 women with frequent sudden urine leaks received the implant. The main goal was to see if at least half of them had a 50% or greater reduction in leaks after 6 months. The study also tracked safety for a year.

What this could mean

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

Active substance
implantable tibial nerve stimulator (BlueWind RENOVA iStim™ system)
What this could lead to
If successful, this device could offer a long-term, minimally invasive option to reduce sudden urine leakage in people with overactive bladder.
What could go wrong
This is a single completed study with no control group, so results may not apply to everyone. The device requires surgery to implant, and risks include infection or device malfunction.

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

282 people

The number who actually took part.

Started

Jun 2019

Finished

Jan 2025

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

Female participants only

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: * Female aged 18 or greater (21 in the US) * More than or equal to 6 months history of UUI diagnosis * Patient who is mentally competent with the ability to understand and comply with the requirements of the study Exclusion Criteria: * Any significant medical condition that is likely to interfere with study procedures * Patients who are breastfeeding * Predominant stress incontinence * Have a life expectancy of less than 1 year * Diagnosis of interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines

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Conditions

The condition(s) this trial relates to.

overactive bladder

As listed by the trial registrant

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

Treatment of patients suffering from overactive bladder (OAB)

Contacts and locations

Locations

  • Academic Hospital Maastricht

    Maastricht, Netherlands

  • Adult Pediatric Urology & Urogynecology

    Omaha, Nebraska, 68114, United States

  • Birmingham Women's and Children's NHS Foundation Trust

    Birmingham, United Kingdom

  • Chesapeake Urology - Hanover

    Hanover, Maryland, 21076, United States

  • Chesapeake Urology - Owing Mills

    Owings Mills, Maryland, 21117, United States

  • Comprehensive Urologic Care

    Lake Barrington, Illinois, 60010, United States

  • Duke Urogynecology

    Durham, North Carolina, 27707, United States

  • Florida Urology Partners

    Tampa, Florida, 33615, United States

  • Imperial College, St. Mary's Hospital

    London, W2 1NY, United Kingdom

  • Isala

    Zwolle, 8025 AB, Netherlands

  • Kaiser Permanente

    San Diego, California, 92110, United States

  • Minnesota Urology

    Woodbury, Minnesota, 55125, United States

  • Norwalk Urology

    Norwalk, Connecticut, 06850, United States

  • Radboud University Medical Center

    Nijmegen, Netherlands

  • Regional Urology, LLC

    Shreveport, Louisiana, 71106, United States

  • Rijnstate Hospital

    Arnhem, Netherlands

  • Sanford Health

    Sioux Falls, South Dakota, 57105, United States

  • Southern Urogynocology

    West Columbia, South Carolina, 29169, United States

  • UMC Utrecht

    Utrecht, Netherlands

  • UZ Leuven

    Leuven, 3000, Belgium

  • University Hospital Antwerp

    Antwerp, 2650, Belgium

  • University of California Irvine

    Orange, California, 92868, United States

  • University of Washington

    Seattle, Washington, 98195, United States