New implant aims to stop Post-Prostate surgery leaks
NCT ID NCT03650244
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
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100 people
The number who actually took part.
- Started
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Nov 2016
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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APHP Hôpital Henry Mondor
Créteil, 94000, France
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CHU Nancy
Nancy, France
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CHU Nice
Nice, France
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CHU Nimes
Nîmes, 30029, France
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CHU Strasbourg
Strasbourg, France
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CHU Toulouse
Toulouse, France
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CHU de Besançon
Besançon, France
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CHU de Dijon
Dijon, France
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CHU de Limoges
Limoges, France
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Hôpital Foch
Suresnes, 92151, France
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