Clinical trial NCT03650244: Nationwide Observation Study to Evaluate the Efficacy and Tolerance of the Adjustable Medical Device REMEEX® in the Treatment of Male Stress Urinary Incontinence
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Incontinence,Stress
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 suffering from moderate stress incontinence (pure or predominant) following radical prostatectomy surgery for prostate cancer, for at least 12 months, unresolved after of pelvic floor reeducation, regardless of the surgical procedure used or of treatment with radiotherapy

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
timeFrame: 1 month
measure: Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
timeFrame: 6 months
measure: Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
timeFrame: 1 year
measure: Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
timeFrame: 2 years
measure: Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
timeFrame: 3 years
measure: Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
timeFrame: 4 years
measure: Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy
timeFrame: 5 years
Secondary outcomes:
measure: Normal clinical examination
timeFrame: month 1
measure: Normal clinical examination
timeFrame: Month 6
measure: Normal clinical examination
timeFrame: Year 1
measure: Normal clinical examination
timeFrame: Year 2
measure: Normal clinical examination
timeFrame: Year 3
measure: Normal clinical examination
timeFrame: Year 4
measure: Normal clinical examination
timeFrame: Year 5
measure: urinary output
timeFrame: Month 1
measure: urinary output
timeFrame: Month 6
measure: urinary output
timeFrame: year 1
measure: urinary output
timeFrame: year 2
measure: urinary output
timeFrame: year 3
measure: urinary output
timeFrame: year 4
measure: urinary output
timeFrame: year 5
measure: Volume of urine
timeFrame: month 1
measure: Volume of urine
timeFrame: month 6
measure: Volume of urine
timeFrame: year 1
measure: Volume of urine
timeFrame: year 2
measure: Volume of urine
timeFrame: year 3
measure: Volume of urine
timeFrame: year 4
measure: Volume of urine
timeFrame: year 5
measure: Post-void residual urine volume
timeFrame: Month 1
measure: Post-void residual urine volume
timeFrame: Month 6
measure: Post-void residual urine volume
timeFrame: year 1
measure: Post-void residual urine volume
timeFrame: year 2
measure: Post-void residual urine volume
timeFrame: year 3
measure: Post-void residual urine volume
timeFrame: year 4
measure: Post-void residual urine volume
timeFrame: year 5
measure: cystoscopy
timeFrame: Month 1
measure: cystoscopy
timeFrame: Month 6
measure: cystoscopy
timeFrame: year 1
measure: cystoscopy
timeFrame: year 2
measure: cystoscopy
timeFrame: year 3
measure: cystoscopy
timeFrame: year 4
measure: cystoscopy
timeFrame: year 5
measure: readjustment of the REMEEX medical device
timeFrame: Month 1
measure: readjustment of the REMEEX medical device
timeFrame: Month 6
measure: readjustment of the REMEEX medical device
timeFrame: Year 1
measure: readjustment of the REMEEX medical device
timeFrame: Year 2
measure: readjustment of the REMEEX medical device
timeFrame: Year 3
measure: readjustment of the REMEEX medical device
timeFrame: Year 4
measure: readjustment of the REMEEX medical device
timeFrame: Year 5
measure: General improvement of symptoms
timeFrame: 1 month
measure: General improvement of symptoms
timeFrame: 6 months
measure: General improvement of symptoms
timeFrame: 1 year
measure: General improvement of symptoms
timeFrame: 2 years
measure: General improvement of symptoms
timeFrame: 3 years
measure: General improvement of symptoms
timeFrame: 4 years
measure: General improvement of symptoms
timeFrame: 5 years
measure: Improvement of urinary symptoms
timeFrame: 1 month
measure: Improvement of urinary symptoms
timeFrame: 6 months
measure: Improvement of urinary symptoms
timeFrame: 1 year
measure: Improvement of urinary symptoms
timeFrame: 2 years
measure: Improvement of urinary symptoms
timeFrame: 3 years
measure: Improvement of urinary symptoms
timeFrame: 4 years
measure: Improvement of urinary symptoms
timeFrame: 5 years
measure: Side effects or complications
timeFrame: 1 month
measure: Side effects or complications
timeFrame: 6 months
measure: Side effects or complications
timeFrame: 1 year
measure: Side effects or complications
timeFrame: 2 years
measure: Side effects or complications
timeFrame: 3 years
measure: Side effects or complications
timeFrame: 4 years
measure: Side effects or complications
timeFrame: 5 years
measure: Reliability and ease of use of the device
timeFrame: 1 month
measure: Reliability and ease of use of the device
timeFrame: 6 months
measure: Reliability and ease of use of the device
timeFrame: 1 year
measure: Reliability and ease of use of the device
timeFrame: 2 years
measure: Reliability and ease of use of the device
timeFrame: 3 years
measure: Reliability and ease of use of the device
timeFrame: 4 years
measure: Reliability and ease of use of the device
timeFrame: 5 years
measure: Patient incontinence-related quality of life
timeFrame: 1 month
measure: Patient incontinence-related quality of life
timeFrame: 6 months
measure: Patient incontinence-related quality of life
timeFrame: 1 year
measure: Patient incontinence-related quality of life
timeFrame: 2 years
measure: Patient incontinence-related quality of life
timeFrame: 3 years
measure: Patient incontinence-related quality of life
timeFrame: 4 years
measure: Patient incontinence-related quality of life
timeFrame: 5 years
measure: Patient sexual-related quality of life
timeFrame: 1 month
measure: Patient sexual-related quality of life
timeFrame: 6 months
measure: Patient sexual-related quality of life
timeFrame: 1 year
measure: Patient sexual-related quality of life
timeFrame: 2 years
measure: Patient sexual-related quality of life
timeFrame: 3 years
measure: Patient sexual-related quality of life
timeFrame: 4 years
measure: Patient sexual-related quality of life
timeFrame: 5 years
measure: Satisfaction of use by the surgeon.
timeFrame: Day 0
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Créteil
country: France
facility: APHP Hôpital Henry Mondor
city: Dijon
country: France
facility: CHU de Dijon
city: Limoges
country: France
facility: CHU de Limoges
city: Nancy
country: France
facility: CHU Nancy
city: Nice
country: France
facility: CHU Nice
city: Nîmes
country: France
facility: CHU Nimes
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
References: