Tiny implant zaps bladder nerves to curb leaks

NCT ID NCT03596671

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

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