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New registry tracks artificial sphincter success for female incontinence

NCT ID NCT04114266

Disease control Sponsor: European Association of Urology Research Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This registry follows 180 women receiving an artificial urinary sphincter for stress incontinence caused by a weak sphincter. Researchers measure how many become dry (using no pads or just one light pad) and how long that dryness lasts over 5 years. Participants also report on sexual function and quality of life through questionnaires.

What this could mean

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

Active substance
Artificial urinary sphincter surgery
What this could lead to
If successful, this registry could confirm that artificial urinary sphincter surgery is a reliable option for women with severe stress incontinence, improving continence and quality of life.
What could go wrong
This is an observational registry, not a controlled trial, so results may not prove cause and effect. Surgery carries risks like infection, device malfunction, or need for revision.

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.

Participants

180 people

The number who actually took part.

Started

Jun 2020

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Female patients undergoing AUS implantation surgery (Robot-assisted, Laparoscopic, Open or other) for treatment of stress urinary incontinence due to intrinsic sphincter deficiency.

Ages

18 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: * Patient should be Female and aged over 18 years. * The patient will undergo an initial AUS implantation surgery (Robot-assisted, Laparoscopic, Open or other) for treatment of stress urinary incontinence due to intrinsic sphincter deficiency. * Participant is willing and able to give informed consent for participation in the Registry * Patient is able to complete the questionnaires. Exclusion Criteria: \- Participating center is unable to contribute consecutive patients.

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Conditions

The condition(s) this trial relates to.

female stress incontinence Lower Urinary Tract Symptoms 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.

Lower urinary tract symptoms Urinary incontinence Urinary incontinence,stress Urination disorders Urologic diseases

Contacts and locations

Locations

  • Addenbrooks Hospital

    Cambridge, United Kingdom

  • CHU Nancy

    Vandœuvre-lès-Nancy, France

  • CHU Rangueil

    Toulouse, France

  • CHU de Lille

    Lille, France

  • CHU de Limoges

    Limoges, France

  • Clinique urologique CHU de NANTES

    Nantes, France

  • Hospital de La Princesa

    Madrid, Spain

  • Hôpital Lyon Sud

    Lyon, France

  • Hôpital de la Pitié-Salpêtrière

    Paris, France

  • Hôpital la Conception

    Marseille, France

  • Klinikum Lippe

    Detmold, Germany

  • Maastricht UMC+

    Maastricht, Netherlands

  • Marqués de Valdecilla University Hospital

    Santander, Spain

  • Thomayer Hospital

    Prague, Czechia

  • Universitair Ziekenhuis Gent

    Ghent, Belgium

  • University Hospital Bordeaux

    Bordeaux, France

  • University Hospital Leuven

    Leuven, 3000, Belgium

  • University Hospital of Nimes

    Nîmes, France

  • University of Rennes, Department of Urology

    Rennes, 35000, France

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