New adjustable implant aims to stop leakage in women

NCT ID NCT04248283

Recruiting now Disease control Sponsor: Uromedica Source: ClinicalTrials.gov ↗

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.

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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.

URINARY INCONTINENCE URINARY INCONTINENCE,STRESS

Contacts and locations

Locations

CHI Health Research Center
RECRUITING

Omaha, Nebraska, 68124, United States
CHU de Nantes
RECRUITING

Nantes, 44000, France
Hôpital de la Conception - Marseille
RECRUITING

Marseille, 13005, France
Pitié Salpêtrière University Hospital Paris
RECRUITING

Paris, 75013, France
University of Colorado
RECRUITING

Denver, Colorado, 80045, United States

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