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New adjustable implant aims to stop leakage in women

NCT ID NCT04248283

Disease control Sponsor: Uromedica Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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

About 167 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2021

Expected to finish

May 2032

An estimate. End dates often move.

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

22 years and older

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: 1. Female at least 22 years old 2. Diagnosed with stress urinary incontinence with primary Intrinsic Sphincter Deficiency 3. Provocative pad weight of greater than 11.0 grams 4. Candidate for surgical intervention 5. Negative urinalysis 6. Normal cystourethroscopy 7. Failed at least 6 months of previous treatment(s) for stress urinary incontinence (e.g., exercise regimen, electrical stimulation, surgical procedures, etc). Note: patients may have failed prior anti-incontinence procedures for SUI (e.g., suspension, sling, or urethral bulking agent) 8. Willing and able to sign informed consent and comply with trial follow-up requirements Exclusion Criteria: 1. Pregnant or lactating 2. Life expectancy of less than 5 years 3. Has uncontrolled diabetes as evidenced by HbA1c over 6.5% and fasting plasma glucose over 130 mg/dL 4. Has auto-immune disease 5. Undergoing radiation therapy 6. Active urinary tract infection 7. Detrusor instability refractory to medication 8. Reduced bladder compliance as defined by a cystometrogram 9. Significant residual volume (greater than 100 ml) after voiding in which detrusor contraction is weak, when the bladder volume is greater than or equal to 250 ml 10. Has, had, or is suspected of having bladder cancer 11. History of bladder stones 12. Urethral stricture evidenced during cystourethroscopy 13. Has a neurogenic bladder that is atonic or has detrusor sphincter dyssynergia 14. Has a diathesis, hemophilia, or a bleeding disorder 15. Has a rectocele, cystocele, urethrocele, enterocele, or pelvic prolapse of grade 3 or higher 16. Had prior pelvic radiotherapy 17. Had a prior artificial urinary sphincter implanted 18. Has a neurogenic condition known to affect bladder/sphincter function

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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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