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

Recruiting

• Conditions: Urinary Incontinence,Stress
• Interventions: Device: REMEEX implantation

• Registration Number: NCT03650244
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-16
• Study First Submitted: 2017-06-30
• Study First Submitted QC: 2018-08-27
• Study First Posted: 2018-08-28
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-28
• Primary Completion: 2023-11
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients fitted with REMEEX	REMEEX implantation	-

Primary Outcome Measures

Name	Time	Method
Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy	5 years	PAD test \< 2 g / 24 h

Secondary Outcome Measures

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

Trial Locations

Locations (10)

CHU de Besançon; 🇫🇷 Besançon, France

APHP Hôpital Henry Mondor; 🇫🇷 Créteil, France

CHU de Limoges; 🇫🇷 Limoges, France

CHU Nancy; 🇫🇷 Nancy, France

CHU de Dijon; 🇫🇷 Dijon, France

CHU Nimes; 🇫🇷 Nîmes, France

CHU Nice; 🇫🇷 Nice, France

Hôpital Foch; 🇫🇷 Suresnes, France

CHU Strasbourg; 🇫🇷 Strasbourg, France

CHU Toulouse; 🇫🇷 Toulouse, France