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 |
|