REMEEX implantation
DeviceDevice implantation
NCT Number: NCT03650244
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
Male
Observational
CHU de Besançon, Besançon, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Device implantation
Time frame: 1 month
PAD test < 2 g / 24 h
Time frame: 6 months
PAD test < 2 g / 24 h
Time frame: 1 year
PAD test < 2 g / 24 h
Time frame: 2 years
PAD test < 2 g / 24 h
Time frame: 3 years
PAD test < 2 g / 24 h
Time frame: 4 years
PAD test < 2 g / 24 h
Time frame: 5 years
PAD test < 2 g / 24 h
Time frame: month 1
Yes / No
Time frame: Month 6
Yes / No
Time frame: Year 1
Yes / No
Time frame: Year 2
Yes / No
Time frame: Year 3
Yes / No
Time frame: Year 4
Yes / No
Time frame: Year 5
Yes / No
Time frame: Month 1
ml/s
Time frame: Month 6
ml/s
Time frame: year 1
ml/s
Time frame: year 2
ml/s
Time frame: year 3
ml/s
Time frame: year 4
ml/s
Time frame: year 5
ml/s
Time frame: month 1
ml
Time frame: month 6
ml
Time frame: year 1
ml
Time frame: year 2
ml
Time frame: year 3
ml
Time frame: year 4
ml
Time frame: year 5
ml
Time frame: Month 1
ml
Time frame: Month 6
ml
Time frame: year 1
ml
Time frame: year 2
ml
Time frame: year 3
ml
Time frame: year 4
ml
Time frame: year 5
ml
Time frame: Month 1
Yes / No
Time frame: Month 6
Yes / No
Time frame: year 1
Yes / No
Time frame: year 2
Yes / No
Time frame: year 3
Yes / No
Time frame: year 4
Yes / No
Time frame: year 5
Yes / No
Time frame: Month 1
Yes / No
Time frame: Month 6
Yes / No
Time frame: Year 1
Yes / No
Time frame: Year 2
Yes / No
Time frame: Year 3
Yes / No
Time frame: Year 4
Yes / No
Time frame: Year 5
Yes / No
Time frame: 1 month
Patient Global Impression of Improvement Questionnaire (PGI-I)
Time frame: 6 months
Patient Global Impression of Improvement Questionnaire (PGI-I)
Time frame: 1 year
Patient Global Impression of Improvement Questionnaire (PGI-I)
Time frame: 2 years
Patient Global Impression of Improvement Questionnaire (PGI-I)
Time frame: 3 years
Patient Global Impression of Improvement Questionnaire (PGI-I)
Time frame: 4 years
Patient Global Impression of Improvement Questionnaire (PGI-I)
Time frame: 5 years
Patient Global Impression of Improvement Questionnaire (PGI-I)
Time frame: 1 month
Urinary Symptom Profile Questionnaire (USP)
Time frame: 6 months
Urinary Symptom Profile Questionnaire (USP)
Time frame: 1 year
Urinary Symptom Profile Questionnaire (USP)
Time frame: 2 years
Urinary Symptom Profile Questionnaire (USP)
Time frame: 3 years
Urinary Symptom Profile Questionnaire (USP)
Time frame: 4 years
Urinary Symptom Profile Questionnaire (USP)
Time frame: 5 years
Urinary Symptom Profile Questionnaire (USP)
Time frame: 1 month
Time frame: 6 months
Time frame: 1 year
Time frame: 2 years
Time frame: 3 years
Time frame: 4 years
Time frame: 5 years
Time frame: 1 month
Time frame: 6 months
Time frame: 1 year
Time frame: 2 years
Time frame: 3 years
Time frame: 4 years
Time frame: 5 years
Time frame: 1 month
Incontinence Quality of Life Questionnaire (I-QOL)
Time frame: 6 months
Incontinence Quality of Life Questionnaire (I-QOL)
Time frame: 1 year
Incontinence Quality of Life Questionnaire (I-QOL)
Time frame: 2 years
Incontinence Quality of Life Questionnaire (I-QOL)
Time frame: 3 years
Incontinence Quality of Life Questionnaire (I-QOL)
Time frame: 4 years
Incontinence Quality of Life Questionnaire (I-QOL)
Time frame: 5 years
Incontinence Quality of Life Questionnaire (I-QOL)
Time frame: 1 month
International Index of Erectile Function (IIEF-5) score
Time frame: 6 months
International Index of Erectile Function (IIEF-5) score
Time frame: 1 year
International Index of Erectile Function (IIEF-5) score
Time frame: 2 years
International Index of Erectile Function (IIEF-5) score
Time frame: 3 years
International Index of Erectile Function (IIEF-5) score
Time frame: 4 years
International Index of Erectile Function (IIEF-5) score
Time frame: 5 years
International Index of Erectile Function (IIEF-5) score
Time frame: Day 0
anological visual scale (between 0 and 10)
Centre Hospitalier Universitaire de Nīmes
Other
Acronym: Remeex
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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