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Urinary Incontinence,StressRemeexNCT03650244

Nationwide Observation Study to Evaluate the Efficacy and Tolerance of the Adjustable Medical Device REMEEX® in the Treatment of Male Stress Urinary Incontinence

An observational study of Urinary Incontinence,Stress, run by Centre Hospitalier Universitaire de Nīmes at 10 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Urinary Incontinence,Stress
What is being tested?
REMEEX implantation
Type of treatment
Medical device
How many people
100 participants
Where
10 sitesFrance
Study dates
16 Nov 2016to Nov 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

France10 sites

  • CHU de Besançon

    Besançon

  • APHP Hôpital Henry Mondor

    Créteil, 94000

  • CHU de Dijon

    Dijon

  • CHU de Limoges

    Limoges

  • CHU Nancy

    Nancy

  • CHU Nice

    Nice

  • CHU Nimes

    Nîmes, 30029

  • CHU Strasbourg

    Strasbourg

  • Hôpital Foch

    Suresnes, 92151

  • CHU Toulouse

    Toulouse

Other trials in France

About this study

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.

Being tested
REMEEX implantation
Medical subject headings
Urinary Incontinence, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REMEEX implantationDevice

    Device implantation

Study groups in NCT03650244
Study groupRoleWhat they receive
Patients fitted with REMEEXNot described
Receives: Device: REMEEX implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy

    PAD test < 2 g / 24 h

    Measured: 1 month

  2. Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy

    PAD test < 2 g / 24 h

    Measured: 6 months

  3. Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy

    PAD test < 2 g / 24 h

    Measured: 1 year

  4. Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy

    PAD test < 2 g / 24 h

    Measured: 2 years

  5. Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy

    PAD test < 2 g / 24 h

    Measured: 3 years

  6. Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy

    PAD test < 2 g / 24 h

    Measured: 4 years

  7. Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy

    PAD test < 2 g / 24 h

    Measured: 5 years

Secondary outcomes (85)

  1. Normal clinical examination

    Yes / No

    Measured: month 1

  2. Normal clinical examination

    Yes / No

    Measured: Month 6

  3. Normal clinical examination

    Yes / No

    Measured: Year 1

  4. Normal clinical examination

    Yes / No

    Measured: Year 2

  5. Normal clinical examination

    Yes / No

    Measured: Year 3

  6. Normal clinical examination

    Yes / No

    Measured: Year 4

  7. Normal clinical examination

    Yes / No

    Measured: Year 5

  8. urinary output

    ml/s

    Measured: Month 1

  9. urinary output

    ml/s

    Measured: Month 6

  10. urinary output

    ml/s

    Measured: year 1

  11. urinary output

    ml/s

    Measured: year 2

  12. urinary output

    ml/s

    Measured: year 3

  13. urinary output

    ml/s

    Measured: year 4

  14. urinary output

    ml/s

    Measured: year 5

  15. Volume of urine

    ml

    Measured: month 1

  16. Volume of urine

    ml

    Measured: month 6

  17. Volume of urine

    ml

    Measured: year 1

  18. Volume of urine

    ml

    Measured: year 2

  19. Volume of urine

    ml

    Measured: year 3

  20. Volume of urine

    ml

    Measured: year 4

  21. Volume of urine

    ml

    Measured: year 5

  22. Post-void residual urine volume

    ml

    Measured: Month 1

  23. Post-void residual urine volume

    ml

    Measured: Month 6

  24. Post-void residual urine volume

    ml

    Measured: year 1

  25. Post-void residual urine volume

    ml

    Measured: year 2

  26. Post-void residual urine volume

    ml

    Measured: year 3

  27. Post-void residual urine volume

    ml

    Measured: year 4

  28. Post-void residual urine volume

    ml

    Measured: year 5

  29. cystoscopy

    Yes / No

    Measured: Month 1

  30. cystoscopy

    Yes / No

    Measured: Month 6

  31. cystoscopy

    Yes / No

    Measured: year 1

  32. cystoscopy

    Yes / No

    Measured: year 2

  33. cystoscopy

    Yes / No

    Measured: year 3

  34. cystoscopy

    Yes / No

    Measured: year 4

  35. cystoscopy

    Yes / No

    Measured: year 5

  36. readjustment of the REMEEX medical device

    Yes / No

    Measured: Month 1

  37. readjustment of the REMEEX medical device

    Yes / No

    Measured: Month 6

  38. readjustment of the REMEEX medical device

    Yes / No

    Measured: Year 1

  39. readjustment of the REMEEX medical device

    Yes / No

    Measured: Year 2

  40. readjustment of the REMEEX medical device

    Yes / No

    Measured: Year 3

  41. readjustment of the REMEEX medical device

    Yes / No

    Measured: Year 4

  42. readjustment of the REMEEX medical device

    Yes / No

    Measured: Year 5

  43. General improvement of symptoms

    Patient Global Impression of Improvement Questionnaire (PGI-I)

    Measured: 1 month

  44. General improvement of symptoms

    Patient Global Impression of Improvement Questionnaire (PGI-I)

    Measured: 6 months

  45. General improvement of symptoms

    Patient Global Impression of Improvement Questionnaire (PGI-I)

    Measured: 1 year

  46. General improvement of symptoms

    Patient Global Impression of Improvement Questionnaire (PGI-I)

    Measured: 2 years

  47. General improvement of symptoms

    Patient Global Impression of Improvement Questionnaire (PGI-I)

    Measured: 3 years

  48. General improvement of symptoms

    Patient Global Impression of Improvement Questionnaire (PGI-I)

    Measured: 4 years

  49. General improvement of symptoms

    Patient Global Impression of Improvement Questionnaire (PGI-I)

    Measured: 5 years

  50. Improvement of urinary symptoms

    Urinary Symptom Profile Questionnaire (USP)

    Measured: 1 month

  51. Improvement of urinary symptoms

    Urinary Symptom Profile Questionnaire (USP)

    Measured: 6 months

  52. Improvement of urinary symptoms

    Urinary Symptom Profile Questionnaire (USP)

    Measured: 1 year

  53. Improvement of urinary symptoms

    Urinary Symptom Profile Questionnaire (USP)

    Measured: 2 years

  54. Improvement of urinary symptoms

    Urinary Symptom Profile Questionnaire (USP)

    Measured: 3 years

  55. Improvement of urinary symptoms

    Urinary Symptom Profile Questionnaire (USP)

    Measured: 4 years

  56. Improvement of urinary symptoms

    Urinary Symptom Profile Questionnaire (USP)

    Measured: 5 years

  57. Side effects or complications

    Measured: 1 month

  58. Side effects or complications

    Measured: 6 months

  59. Side effects or complications

    Measured: 1 year

  60. Side effects or complications

    Measured: 2 years

  61. Side effects or complications

    Measured: 3 years

  62. Side effects or complications

    Measured: 4 years

  63. Side effects or complications

    Measured: 5 years

  64. Reliability and ease of use of the device

    Measured: 1 month

  65. Reliability and ease of use of the device

    Measured: 6 months

  66. Reliability and ease of use of the device

    Measured: 1 year

  67. Reliability and ease of use of the device

    Measured: 2 years

  68. Reliability and ease of use of the device

    Measured: 3 years

  69. Reliability and ease of use of the device

    Measured: 4 years

  70. Reliability and ease of use of the device

    Measured: 5 years

  71. Patient incontinence-related quality of life

    Incontinence Quality of Life Questionnaire (I-QOL)

    Measured: 1 month

  72. Patient incontinence-related quality of life

    Incontinence Quality of Life Questionnaire (I-QOL)

    Measured: 6 months

  73. Patient incontinence-related quality of life

    Incontinence Quality of Life Questionnaire (I-QOL)

    Measured: 1 year

  74. Patient incontinence-related quality of life

    Incontinence Quality of Life Questionnaire (I-QOL)

    Measured: 2 years

  75. Patient incontinence-related quality of life

    Incontinence Quality of Life Questionnaire (I-QOL)

    Measured: 3 years

  76. Patient incontinence-related quality of life

    Incontinence Quality of Life Questionnaire (I-QOL)

    Measured: 4 years

  77. Patient incontinence-related quality of life

    Incontinence Quality of Life Questionnaire (I-QOL)

    Measured: 5 years

  78. Patient sexual-related quality of life

    International Index of Erectile Function (IIEF-5) score

    Measured: 1 month

  79. Patient sexual-related quality of life

    International Index of Erectile Function (IIEF-5) score

    Measured: 6 months

  80. Patient sexual-related quality of life

    International Index of Erectile Function (IIEF-5) score

    Measured: 1 year

  81. Patient sexual-related quality of life

    International Index of Erectile Function (IIEF-5) score

    Measured: 2 years

  82. Patient sexual-related quality of life

    International Index of Erectile Function (IIEF-5) score

    Measured: 3 years

  83. Patient sexual-related quality of life

    International Index of Erectile Function (IIEF-5) score

    Measured: 4 years

  84. Patient sexual-related quality of life

    International Index of Erectile Function (IIEF-5) score

    Measured: 5 years

  85. Satisfaction of use by the surgeon.

    anological visual scale (between 0 and 10)

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2018
  2. Study start16 Nov 2016
  3. Primary completionNov 2028 (estimated)
  4. Study completionNov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03650244
Sponsor's protocol ID
LOCAL/2016/LW-01
Acronym
Remeex
Status last verified
Jun 2026
First submitted
30 Jun 2017
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Urinary Incontinence,Stress, run by Centre Hospitalier Universitaire de Nīmes at 10 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy (time frame: 1 month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03650244.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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