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New implant aims to stop Post-Prostate surgery leaks

NCT ID NCT03650244

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study follows 100 men who have had prostate surgery and still struggle with stress urinary incontinence (leaking urine when coughing or moving). They receive an adjustable implant called REMEEX to help control leakage. Researchers will track how well it works, side effects, and quality of life over 5 years.

What this could mean

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

Active substance
REMEEX implant (adjustable medical device)
What this could lead to
If successful, this could confirm REMEEX as a reliable option for men with persistent incontinence after prostate surgery, improving quality of life.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. The device involves 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.

Participants

100 people

The number who actually took part.

Started

Nov 2016

Expected to finish

Nov 2028

An estimate. End dates often move.

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

Patients over 18 suffering from moderate stress incontinence (pure or predominant) following radical prostatectomy surgery for prostate cancer, for at least 12 months, unresolved after of pelvic floor reeducation, regardless of the surgical procedure used or of treatment with radiotherapy

Ages

18 years and older

Sex

Male 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: * The patient has been informed about the study * The patient is at least 18 years old * Patient suffering from moderate stress incontinence (pure or predominant) following radical prostatectomy surgery, for at least 12 months, unresolved after of pelvic floor reeducation * Patient scheduled for REMEEX® implant Exclusion Criteria: * It proves impossible to give the patient clear information * Patient refuses to participate * Life expectancy of the patient estimated to be less than the 5 year follow-up * Impossible to contact patient after hospitalization * Radiotherapy of less than 6 month * Patient unable to fill in questionnaire * Incapably of performing pad test at 24 hours * Recurrent symptomatic prostate cancer * Mixed incontinence with urgency incontinence * Bladder outlet obstruction: stenosis of the vesico-urethral anastomosis or untreated urethral stricture. * Post void residual \>100ml * Other cancer under treatment or progressing * Kidney injury, hepatocellular insufficiency * Auto-immune disease * Neurological-origin urinary incontinence (stroke, MS, Parkinson's) * Incontinence arising from surgery other than prostatectomy * recurrent gross hematuria * Recurrent urinary infection * Bladder stones

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Conditions

The condition(s) this trial relates to.

female stress incontinence Urinary Incontinence, Stress

As listed by the trial registrant

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

Contacts and locations

Locations

  • APHP Hôpital Henry Mondor

    Créteil, 94000, France

  • CHU Nancy

    Nancy, France

  • CHU Nice

    Nice, France

  • CHU Nimes

    Nîmes, 30029, France

  • CHU Strasbourg

    Strasbourg, France

  • CHU Toulouse

    Toulouse, France

  • CHU de Besançon

    Besançon, France

  • CHU de Dijon

    Dijon, France

  • CHU de Limoges

    Limoges, France

  • Hôpital Foch

    Suresnes, 92151, France

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