Nationwide Observation Study to Evaluate the Efficacy and Tolerance of the Adjustable Medical Device REMEEX® in the Treatment of Male Stress Urinary Incontinence

Last updated: September 27, 2022
Sponsor: Centre Hospitalier Universitaire de Nīmes
Overall Status: Active - Recruiting

Phase

N/A

Condition

Enuresis

Urinary Incontinence

Treatment

N/A

Clinical Study ID

NCT03650244
LOCAL/2016/LW-01
  • Ages > 18
  • Male

Study Summary

We wish to set up a multicentric prospective observational study across France to collate data on the efficacy and tolerance of the Male REMEEX® device in patients with moderate stress urinary incontinence following radical prostatectomy. Patient satisfaction, improvement in quality of life, side effects and complications will also be studied, as will the ease of use of the device from the point of view of the surgeon. A long-term follow-up of 5 years will be conducted.

Eligibility Criteria

Inclusion

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) followingradical prostatectomy surgery, for at least 12 months, unresolved after of pelvicfloor reeducation
  • Patient scheduled for REMEEX® implant

Exclusion

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 untreatedurethral 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

Study Design

Total Participants: 150
Study Start date:
November 16, 2016
Estimated Completion Date:
November 30, 2023

Connect with a study center

  • CHU de Besançon

    Besançon,
    France

    Active - Recruiting

  • APHP Hôpital Henry Mondor

    Créteil, 94000
    France

    Active - Recruiting

  • CHU de Dijon

    Dijon,
    France

    Active - Recruiting

  • CHU de Limoges

    Limoges,
    France

    Active - Recruiting

  • CHU Nancy

    Nancy,
    France

    Active - Recruiting

  • CHU Nice

    Nice,
    France

    Active - Recruiting

  • CHU Nimes

    Nîmes, 30029
    France

    Active - Recruiting

  • CHU Strasbourg

    Strasbourg,
    France

    Active - Recruiting

  • Hôpital Foch

    Suresnes, 92151
    France

    Active - Recruiting

  • CHU Toulouse

    Toulouse,
    France

    Active - Recruiting

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