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

Urinary Incontinence,Stress Clinical Trial

— Remeex  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03650244
• Other study ID #: LOCAL/2016/LW-01
• Status: Recruiting
• Start date: November 16, 2016
• Est. completion date: November 2023

Study information

• Verified date: September 2022
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence,Stress

Intervention

Device:
• REMEEX implantation
Device implantation

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon
France	APHP Hôpital Henry Mondor	Créteil
France	CHU de Dijon	Dijon
France	CHU de Limoges	Limoges
France	CHU Nancy	Nancy
France	CHU Nice	Nice
France	CHU Nimes	Nîmes
France	CHU Strasbourg	Strasbourg
France	Hôpital Foch	Suresnes
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy	PAD test < 2 g / 24 h	1 month
Primary	Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy	PAD test < 2 g / 24 h	6 months
Primary	Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy	PAD test < 2 g / 24 h	1 year
Primary	Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy	PAD test < 2 g / 24 h	2 years
Primary	Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy	PAD test < 2 g / 24 h	3 years
Primary	Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy	PAD test < 2 g / 24 h	4 years
Primary	Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy	PAD test < 2 g / 24 h	5 years
Secondary	Normal clinical examination	Yes / No	month 1
Secondary	Normal clinical examination	Yes / No	Month 6
Secondary	Normal clinical examination	Yes / No	Year 1
Secondary	Normal clinical examination	Yes / No	Year 2
Secondary	Normal clinical examination	Yes / No	Year 3
Secondary	Normal clinical examination	Yes / No	Year 4
Secondary	Normal clinical examination	Yes / No	Year 5
Secondary	urinary output	ml/s	Month 1
Secondary	urinary output	ml/s	Month 6
Secondary	urinary output	ml/s	year 1
Secondary	urinary output	ml/s	year 2
Secondary	urinary output	ml/s	year 3
Secondary	urinary output	ml/s	year 4
Secondary	urinary output	ml/s	year 5
Secondary	Volume of urine	ml	month 1
Secondary	Volume of urine	ml	month 6
Secondary	Volume of urine	ml	year 1
Secondary	Volume of urine	ml	year 2
Secondary	Volume of urine	ml	year 3
Secondary	Volume of urine	ml	year 4
Secondary	Volume of urine	ml	year 5
Secondary	Post-void residual urine volume	ml	Month 1
Secondary	Post-void residual urine volume	ml	Month 6
Secondary	Post-void residual urine volume	ml	year 1
Secondary	Post-void residual urine volume	ml	year 2
Secondary	Post-void residual urine volume	ml	year 3
Secondary	Post-void residual urine volume	ml	year 4
Secondary	Post-void residual urine volume	ml	year 5
Secondary	cystoscopy	Yes / No	Month 1
Secondary	cystoscopy	Yes / No	Month 6
Secondary	cystoscopy	Yes / No	year 1
Secondary	cystoscopy	Yes / No	year 2
Secondary	cystoscopy	Yes / No	year 3
Secondary	cystoscopy	Yes / No	year 4
Secondary	cystoscopy	Yes / No	year 5
Secondary	readjustment of the REMEEX medical device	Yes / No	Month 1
Secondary	readjustment of the REMEEX medical device	Yes / No	Month 6
Secondary	readjustment of the REMEEX medical device	Yes / No	Year 1
Secondary	readjustment of the REMEEX medical device	Yes / No	Year 2
Secondary	readjustment of the REMEEX medical device	Yes / No	Year 3
Secondary	readjustment of the REMEEX medical device	Yes / No	Year 4
Secondary	readjustment of the REMEEX medical device	Yes / No	Year 5
Secondary	General improvement of symptoms	Patient Global Impression of Improvement Questionnaire (PGI-I)	1 month
Secondary	General improvement of symptoms	Patient Global Impression of Improvement Questionnaire (PGI-I)	6 months
Secondary	General improvement of symptoms	Patient Global Impression of Improvement Questionnaire (PGI-I)	1 year
Secondary	General improvement of symptoms	Patient Global Impression of Improvement Questionnaire (PGI-I)	2 years
Secondary	General improvement of symptoms	Patient Global Impression of Improvement Questionnaire (PGI-I)	3 years
Secondary	General improvement of symptoms	Patient Global Impression of Improvement Questionnaire (PGI-I)	4 years
Secondary	General improvement of symptoms	Patient Global Impression of Improvement Questionnaire (PGI-I)	5 years
Secondary	Improvement of urinary symptoms	Urinary Symptom Profile Questionnaire (USP)	1 month
Secondary	Improvement of urinary symptoms	Urinary Symptom Profile Questionnaire (USP)	6 months
Secondary	Improvement of urinary symptoms	Urinary Symptom Profile Questionnaire (USP)	1 year
Secondary	Improvement of urinary symptoms	Urinary Symptom Profile Questionnaire (USP)	2 years
Secondary	Improvement of urinary symptoms	Urinary Symptom Profile Questionnaire (USP)	3 years
Secondary	Improvement of urinary symptoms	Urinary Symptom Profile Questionnaire (USP)	4 years
Secondary	Improvement of urinary symptoms	Urinary Symptom Profile Questionnaire (USP)	5 years
Secondary	Side effects or complications		1 month
Secondary	Side effects or complications		6 months
Secondary	Side effects or complications		1 year
Secondary	Side effects or complications		2 years
Secondary	Side effects or complications		3 years
Secondary	Side effects or complications		4 years
Secondary	Side effects or complications		5 years
Secondary	Reliability and ease of use of the device		1 month
Secondary	Reliability and ease of use of the device		6 months
Secondary	Reliability and ease of use of the device		1 year
Secondary	Reliability and ease of use of the device		2 years
Secondary	Reliability and ease of use of the device		3 years
Secondary	Reliability and ease of use of the device		4 years
Secondary	Reliability and ease of use of the device		5 years
Secondary	Patient incontinence-related quality of life	Incontinence Quality of Life Questionnaire (I-QOL)	1 month
Secondary	Patient incontinence-related quality of life	Incontinence Quality of Life Questionnaire (I-QOL)	6 months
Secondary	Patient incontinence-related quality of life	Incontinence Quality of Life Questionnaire (I-QOL)	1 year
Secondary	Patient incontinence-related quality of life	Incontinence Quality of Life Questionnaire (I-QOL)	2 years
Secondary	Patient incontinence-related quality of life	Incontinence Quality of Life Questionnaire (I-QOL)	3 years
Secondary	Patient incontinence-related quality of life	Incontinence Quality of Life Questionnaire (I-QOL)	4 years
Secondary	Patient incontinence-related quality of life	Incontinence Quality of Life Questionnaire (I-QOL)	5 years
Secondary	Patient sexual-related quality of life	International Index of Erectile Function (IIEF-5) score	1 month
Secondary	Patient sexual-related quality of life	International Index of Erectile Function (IIEF-5) score	6 months
Secondary	Patient sexual-related quality of life	International Index of Erectile Function (IIEF-5) score	1 year
Secondary	Patient sexual-related quality of life	International Index of Erectile Function (IIEF-5) score	2 years
Secondary	Patient sexual-related quality of life	International Index of Erectile Function (IIEF-5) score	3 years
Secondary	Patient sexual-related quality of life	International Index of Erectile Function (IIEF-5) score	4 years
Secondary	Patient sexual-related quality of life	International Index of Erectile Function (IIEF-5) score	5 years
Secondary	Satisfaction of use by the surgeon.	anological visual scale (between 0 and 10)	Day 0