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

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence,Stress
• Intervention / Treatment: Device: REMEEX implantation

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• France
  • Besançon, France
    • Recruiting
    • CHU de Besançon
    • Contact: Chabannes, MD; Email: echabannes@chu-besancon.fr
  • Créteil, France, 94000
    • Recruiting
    • APHP Hôpital Henry Mondor
    • Contact: Rene Yiou, MD; Email: yiourene@gmail.com
  • Dijon, France
    • Recruiting
    • CHU de Dijon
    • Contact: Eric Mourey, MD; Email: eric.mourey@chu-dijon.fr
  • Limoges, France
    • Recruiting
    • CHU de Limoges
    • Contact: Descazeaux, MD; Email: aurelien.descazeaud@chu-limoges.fr
  • Nancy, France
    • Recruiting
    • CHU Nancy
    • Contact: Lemelle, MD; Email: jl.lemelle@chru-nancy.fr
    • Sub-Investigator: Hubert, MD
    • Sub-Investigator: Lecoanet, MD
  • Nice, France
    • Recruiting
    • CHU Nice
    • Contact: Daniel Chevalier, MD; Email: chevalier.d@chu-nice.fr
  • Nîmes, France, 30029
    • Recruiting
    • CHU Nîmes
    • Contact: Laurent Wagner, MD; Phone Number: +33 (0)6 16 57 02 07; Email: laurent.wagner@chu-nimes.fr
  • Strasbourg, France
    • Recruiting
    • CHU Strasbourg
    • Contact: Christian Saussine, MD; Email: christian.saussine@chru-strasbourg.fr
  • Suresnes, France, 92151
    • Recruiting
    • Hopital Foch
    • Contact: Cour, MD; Email: f.cour@hopital-foch.org
    • Sub-Investigator: Vidart, MD
  • Toulouse, France
    • Recruiting
    • CHU Toulouse
    • Contact: Game, MD; Email: game.x@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients fitted with REMEEX	Device: REMEEX implantation; Device implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normal clinical examination	Yes / No	month 1
Normal clinical examination	Yes / No	Month 6
Normal clinical examination	Yes / No	Year 1
Normal clinical examination	Yes / No	Year 2
Normal clinical examination	Yes / No	Year 3
Normal clinical examination	Yes / No	Year 4
Normal clinical examination	Yes / No	Year 5
urinary output	ml/s	Month 1
urinary output	ml/s	Month 6
urinary output	ml/s	year 1
urinary output	ml/s	year 2
urinary output	ml/s	year 3
urinary output	ml/s	year 4
urinary output	ml/s	year 5
Volume of urine	ml	month 1
Volume of urine	ml	month 6
Volume of urine	ml	year 1
Volume of urine	ml	year 2
Volume of urine	ml	year 3
Volume of urine	ml	year 4
Volume of urine	ml	year 5
Post-void residual urine volume	ml	Month 1
Post-void residual urine volume	ml	Month 6
Post-void residual urine volume	ml	year 1
Post-void residual urine volume	ml	year 2
Post-void residual urine volume	ml	year 3
Post-void residual urine volume	ml	year 4
Post-void residual urine volume	ml	year 5
cystoscopy	Yes / No	Month 1
cystoscopy	Yes / No	Month 6
cystoscopy	Yes / No	year 1
cystoscopy	Yes / No	year 2
cystoscopy	Yes / No	year 3
cystoscopy	Yes / No	year 4
cystoscopy	Yes / No	year 5
readjustment of the REMEEX medical device	Yes / No	Month 1
readjustment of the REMEEX medical device	Yes / No	Month 6
readjustment of the REMEEX medical device	Yes / No	Year 1
readjustment of the REMEEX medical device	Yes / No	Year 2
readjustment of the REMEEX medical device	Yes / No	Year 3
readjustment of the REMEEX medical device	Yes / No	Year 4
readjustment of the REMEEX medical device	Yes / No	Year 5
General improvement of symptoms	Patient Global Impression of Improvement Questionnaire (PGI-I)	1 month
General improvement of symptoms	Patient Global Impression of Improvement Questionnaire (PGI-I)	6 months
General improvement of symptoms	Patient Global Impression of Improvement Questionnaire (PGI-I)	1 year
General improvement of symptoms	Patient Global Impression of Improvement Questionnaire (PGI-I)	2 years
General improvement of symptoms	Patient Global Impression of Improvement Questionnaire (PGI-I)	3 years
General improvement of symptoms	Patient Global Impression of Improvement Questionnaire (PGI-I)	4 years
General improvement of symptoms	Patient Global Impression of Improvement Questionnaire (PGI-I)	5 years
Improvement of urinary symptoms	Urinary Symptom Profile Questionnaire (USP)	1 month
Improvement of urinary symptoms	Urinary Symptom Profile Questionnaire (USP)	6 months
Improvement of urinary symptoms	Urinary Symptom Profile Questionnaire (USP)	1 year
Improvement of urinary symptoms	Urinary Symptom Profile Questionnaire (USP)	2 years
Improvement of urinary symptoms	Urinary Symptom Profile Questionnaire (USP)	3 years
Improvement of urinary symptoms	Urinary Symptom Profile Questionnaire (USP)	4 years
Improvement of urinary symptoms	Urinary Symptom Profile Questionnaire (USP)	5 years
Side effects or complications		1 month
Side effects or complications		6 months
Side effects or complications		1 year
Side effects or complications		2 years
Side effects or complications		3 years
Side effects or complications		4 years
Side effects or complications		5 years
Reliability and ease of use of the device		1 month
Reliability and ease of use of the device		6 months
Reliability and ease of use of the device		1 year
Reliability and ease of use of the device		2 years
Reliability and ease of use of the device		3 years
Reliability and ease of use of the device		4 years
Reliability and ease of use of the device		5 years
Patient incontinence-related quality of life	Incontinence Quality of Life Questionnaire (I-QOL)	1 month
Patient incontinence-related quality of life	Incontinence Quality of Life Questionnaire (I-QOL)	6 months
Patient incontinence-related quality of life	Incontinence Quality of Life Questionnaire (I-QOL)	1 year
Patient incontinence-related quality of life	Incontinence Quality of Life Questionnaire (I-QOL)	2 years
Patient incontinence-related quality of life	Incontinence Quality of Life Questionnaire (I-QOL)	3 years
Patient incontinence-related quality of life	Incontinence Quality of Life Questionnaire (I-QOL)	4 years
Patient incontinence-related quality of life	Incontinence Quality of Life Questionnaire (I-QOL)	5 years
Patient sexual-related quality of life	International Index of Erectile Function (IIEF-5) score	1 month
Patient sexual-related quality of life	International Index of Erectile Function (IIEF-5) score	6 months
Patient sexual-related quality of life	International Index of Erectile Function (IIEF-5) score	1 year
Patient sexual-related quality of life	International Index of Erectile Function (IIEF-5) score	2 years
Patient sexual-related quality of life	International Index of Erectile Function (IIEF-5) score	3 years
Patient sexual-related quality of life	International Index of Erectile Function (IIEF-5) score	4 years
Patient sexual-related quality of life	International Index of Erectile Function (IIEF-5) score	5 years
Satisfaction of use by the surgeon.	anological visual scale (between 0 and 10)	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 16, 2016
• Primary Completion (ANTICIPATED): November 1, 2023
• Study Completion (ANTICIPATED): November 1, 2023

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (ACTUAL): August 28, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: LOCAL/2016/LW-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No