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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03650244
Other study ID # LOCAL/2016/LW-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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