New adjustable implant aims to stop leakage in women

NCT ID NCT04248283

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tests a device called Adjustable Continence Therapy (ACT) for women with stress urinary incontinence caused by a weak urethral sphincter. The implant has two balloons placed near the bladder neck that can be adjusted after surgery to improve control. The study will enroll 167 women who have not gotten better with other treatments, and will measure changes in urine leakage and quality of life.

What this could mean

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

Active substance

Adjustable Continence Therapy (ACT) device

What this could lead to

If it works, this could offer a new, adjustable implant option for women with stress urinary incontinence who have not improved with other treatments.

What could go wrong

This is an early, single-arm study without a comparison group, so results may be less reliable. The implant requires surgery and carries risks like 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.

female stress incontinence Lower Urinary Tract Symptoms nocturnal enuresis urethral intrinsic sphincter deficiency Urinary Incontinence Urinary Incontinence, Stress urinary system disorder Urination Disorders

As listed by the trial registrant

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

Contacts and locations

Study contacts

  • Contact

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

  • Contact

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

Locations

  • CHI Health Research Center

    RECRUITING

    Omaha, Nebraska, 68124, United States

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

    Contact

  • CHU de Nantes

    RECRUITING

    Nantes, 44000, France

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

    Contact

  • Hôpital de la Conception - Marseille

    RECRUITING

    Marseille, 13005, France

    Contact

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

  • Pitié Salpêtrière University Hospital Paris

    RECRUITING

    Paris, 75013, France

    Contact

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

  • University of Colorado

    RECRUITING

    Denver, Colorado, 80045, United States

    Contact Email: •••••@•••••

    Contact

    Contact