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

NCT03650244 | Unknown

• 1 other identifier: LOCAL/2016/LW-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Urinary Incontinence,Stress

Outcome Measures

Primary Outcomes (7)

• Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy

  PAD test \< 2 g / 24 h

  1 month

• Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy

  PAD test \< 2 g / 24 h

  6 months

• Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy

  PAD test \< 2 g / 24 h

  1 year

• Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy

  PAD test \< 2 g / 24 h

  2 years

• Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy

  PAD test \< 2 g / 24 h

  3 years

• Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy

  PAD test \< 2 g / 24 h

  4 years

• Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy

  PAD test \< 2 g / 24 h

  5 years

Secondary Outcomes (85)

• Normal clinical examination

  month 1

• Normal clinical examination

  Month 6

• Normal clinical examination

  Year 1

• Normal clinical examination

  Year 2

• Normal clinical examination

  Year 3

Study Arms (1)

Patients fitted with REMEEX

Device: REMEEX implantation

Interventions

REMEEX implantation DEVICE

Device implantation

Patients fitted with REMEEX

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (10)

CHU de Besançon

Besançon, France

RECRUITING

APHP Hôpital Henry Mondor

Créteil, 94000, France

RECRUITING

CHU de Dijon

Dijon, France

RECRUITING

CHU de Limoges

Limoges, France

RECRUITING

CHU Nancy

Nancy, France

RECRUITING

CHU Nice

Nice, France

RECRUITING

CHU Nimes

Nîmes, 30029, France

RECRUITING

CHU Strasbourg

Strasbourg, France

RECRUITING

Hôpital Foch

Suresnes, 92151, France

RECRUITING

CHU Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: August 28, 2018
• Study Start: November 16, 2016
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)