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New implant aims to stop bladder leaks in women

NCT ID NCT06885931

First seen Nov 01, 2025 · Last updated Jun 21, 2026 · Updated 28 times

Summary

This study tests a new, personalized implant (Picostim II) for women with mixed urinary incontinence—a mix of stress and urge leaks. The device stimulates the pudendal nerve to improve bladder control. Researchers will check if it's safe and works well in 86 women who haven't been helped by other treatments.

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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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Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Ghent University Hospital

    RECRUITING

    Ghent, 9000, Belgium

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Guy's Hospital

    NOT_YET_RECRUITING

    London, United Kingdom

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Maastricht UMC

    RECRUITING

    Maastricht, 6229 HX, Netherlands

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Southmead Hospital

    RECRUITING

    Bristol, United Kingdom

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • UZ Leuven

    RECRUITING

    Leuven, Herestraat 49, 3000, Belgium

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Universitair Ziekenhuis Antwerpen

    RECRUITING

    Edegem, 655, 2650, Belgium

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • University College London Hospital

    RECRUITING

    London, NW1 2BU, United Kingdom

    Contact Email: •••••@•••••

What this could mean

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

Active substance

implanted pudendal neuromodulation device (Picostim II system)

What this could lead to

If successful, this could offer a new, personalized treatment option for women with mixed urinary incontinence who haven't found relief from other therapies.

What could go wrong

This is an early feasibility study with only 86 participants, so results may not apply to everyone. The device requires surgery, and risks include infection, device malfunction, or need for reoperation.

Conditions

The condition(s) this trial relates to.

overactive bladder Urinary Incontinence, Stress Urinary Incontinence, Urge

As listed by the trial registrant

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