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 Type
OBSERVATIONAL
Enrollment
150
Device implantation
CHU de Besançon
Besançon, France
RECRUITINGAPHP Hôpital Henry Mondor
Créteil, France
RECRUITINGCHU de Dijon
Dijon, France
RECRUITINGCHU de Limoges
Limoges, France
RECRUITINGCHU Nancy
Nancy, France
RECRUITINGCHU Nice
Nice, France
RECRUITINGCHU Nimes
Nîmes, France
RECRUITINGCHU Strasbourg
Strasbourg, France
RECRUITINGHôpital Foch
Suresnes, France
RECRUITINGCHU Toulouse
Toulouse, France
RECRUITINGEvaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
PAD test \< 2 g / 24 h
Time frame: 1 month
Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
PAD test \< 2 g / 24 h
Time frame: 6 months
Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
PAD test \< 2 g / 24 h
Time frame: 1 year
Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
PAD test \< 2 g / 24 h
Time frame: 2 years
Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
PAD test \< 2 g / 24 h
Time frame: 3 years
Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
PAD test \< 2 g / 24 h
Time frame: 4 years
Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
PAD test \< 2 g / 24 h
Time frame: 5 years
Normal clinical examination
Yes / No
Time frame: month 1
Normal clinical examination
Yes / No
Time frame: Month 6
Normal clinical examination
Yes / No
Time frame: Year 1
Normal clinical examination
Yes / No
Time frame: Year 2
Normal clinical examination
Yes / No
Time frame: Year 3
Normal clinical examination
Yes / No
Time frame: Year 4
Normal clinical examination
Yes / No
Time frame: Year 5
urinary output
ml/s
Time frame: Month 1
urinary output
ml/s
Time frame: Month 6
urinary output
ml/s
Time frame: year 1
urinary output
ml/s
Time frame: year 2
urinary output
ml/s
Time frame: year 3
urinary output
ml/s
Time frame: year 4
urinary output
ml/s
Time frame: year 5
Volume of urine
ml
Time frame: month 1
Volume of urine
ml
Time frame: month 6
Volume of urine
ml
Time frame: year 1
Volume of urine
ml
Time frame: year 2
Volume of urine
ml
Time frame: year 3
Volume of urine
ml
Time frame: year 4
Volume of urine
ml
Time frame: year 5
Post-void residual urine volume
ml
Time frame: Month 1
Post-void residual urine volume
ml
Time frame: Month 6
Post-void residual urine volume
ml
Time frame: year 1
Post-void residual urine volume
ml
Time frame: year 2
Post-void residual urine volume
ml
Time frame: year 3
Post-void residual urine volume
ml
Time frame: year 4
Post-void residual urine volume
ml
Time frame: year 5
cystoscopy
Yes / No
Time frame: Month 1
cystoscopy
Yes / No
Time frame: Month 6
cystoscopy
Yes / No
Time frame: year 1
cystoscopy
Yes / No
Time frame: year 2
cystoscopy
Yes / No
Time frame: year 3
cystoscopy
Yes / No
Time frame: year 4
cystoscopy
Yes / No
Time frame: year 5
readjustment of the REMEEX medical device
Yes / No
Time frame: Month 1
readjustment of the REMEEX medical device
Yes / No
Time frame: Month 6
readjustment of the REMEEX medical device
Yes / No
Time frame: Year 1
readjustment of the REMEEX medical device
Yes / No
Time frame: Year 2
readjustment of the REMEEX medical device
Yes / No
Time frame: Year 3
readjustment of the REMEEX medical device
Yes / No
Time frame: Year 4
readjustment of the REMEEX medical device
Yes / No
Time frame: Year 5
General improvement of symptoms
Patient Global Impression of Improvement Questionnaire (PGI-I)
Time frame: 1 month
General improvement of symptoms
Patient Global Impression of Improvement Questionnaire (PGI-I)
Time frame: 6 months
General improvement of symptoms
Patient Global Impression of Improvement Questionnaire (PGI-I)
Time frame: 1 year
General improvement of symptoms
Patient Global Impression of Improvement Questionnaire (PGI-I)
Time frame: 2 years
General improvement of symptoms
Patient Global Impression of Improvement Questionnaire (PGI-I)
Time frame: 3 years
General improvement of symptoms
Patient Global Impression of Improvement Questionnaire (PGI-I)
Time frame: 4 years
General improvement of symptoms
Patient Global Impression of Improvement Questionnaire (PGI-I)
Time frame: 5 years
Improvement of urinary symptoms
Urinary Symptom Profile Questionnaire (USP)
Time frame: 1 month
Improvement of urinary symptoms
Urinary Symptom Profile Questionnaire (USP)
Time frame: 6 months
Improvement of urinary symptoms
Urinary Symptom Profile Questionnaire (USP)
Time frame: 1 year
Improvement of urinary symptoms
Urinary Symptom Profile Questionnaire (USP)
Time frame: 2 years
Improvement of urinary symptoms
Urinary Symptom Profile Questionnaire (USP)
Time frame: 3 years
Improvement of urinary symptoms
Urinary Symptom Profile Questionnaire (USP)
Time frame: 4 years
Improvement of urinary symptoms
Urinary Symptom Profile Questionnaire (USP)
Time frame: 5 years
Side effects or complications
Time frame: 1 month
Side effects or complications
Time frame: 6 months
Side effects or complications
Time frame: 1 year
Side effects or complications
Time frame: 2 years
Side effects or complications
Time frame: 3 years
Side effects or complications
Time frame: 4 years
Side effects or complications
Time frame: 5 years
Reliability and ease of use of the device
Time frame: 1 month
Reliability and ease of use of the device
Time frame: 6 months
Reliability and ease of use of the device
Time frame: 1 year
Reliability and ease of use of the device
Time frame: 2 years
Reliability and ease of use of the device
Time frame: 3 years
Reliability and ease of use of the device
Time frame: 4 years
Reliability and ease of use of the device
Time frame: 5 years
Patient incontinence-related quality of life
Incontinence Quality of Life Questionnaire (I-QOL)
Time frame: 1 month
Patient incontinence-related quality of life
Incontinence Quality of Life Questionnaire (I-QOL)
Time frame: 6 months
Patient incontinence-related quality of life
Incontinence Quality of Life Questionnaire (I-QOL)
Time frame: 1 year
Patient incontinence-related quality of life
Incontinence Quality of Life Questionnaire (I-QOL)
Time frame: 2 years
Patient incontinence-related quality of life
Incontinence Quality of Life Questionnaire (I-QOL)
Time frame: 3 years
Patient incontinence-related quality of life
Incontinence Quality of Life Questionnaire (I-QOL)
Time frame: 4 years
Patient incontinence-related quality of life
Incontinence Quality of Life Questionnaire (I-QOL)
Time frame: 5 years
Patient sexual-related quality of life
International Index of Erectile Function (IIEF-5) score
Time frame: 1 month
Patient sexual-related quality of life
International Index of Erectile Function (IIEF-5) score
Time frame: 6 months
Patient sexual-related quality of life
International Index of Erectile Function (IIEF-5) score
Time frame: 1 year
Patient sexual-related quality of life
International Index of Erectile Function (IIEF-5) score
Time frame: 2 years
Patient sexual-related quality of life
International Index of Erectile Function (IIEF-5) score
Time frame: 3 years
Patient sexual-related quality of life
International Index of Erectile Function (IIEF-5) score
Time frame: 4 years
Patient sexual-related quality of life
International Index of Erectile Function (IIEF-5) score
Time frame: 5 years
Satisfaction of use by the surgeon.
anological visual scale (between 0 and 10)
Time frame: Day 0
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