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NCT Number: NCT03650244

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

REMEEX implantation

Device

Device implantation

Primary outcomes

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

    Time frame: 1 month

    PAD test < 2 g / 24 h

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

    Time frame: 6 months

    PAD test < 2 g / 24 h

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

    Time frame: 1 year

    PAD test < 2 g / 24 h

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

    Time frame: 2 years

    PAD test < 2 g / 24 h

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

    Time frame: 3 years

    PAD test < 2 g / 24 h

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

    Time frame: 4 years

    PAD test < 2 g / 24 h

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

    Time frame: 5 years

    PAD test < 2 g / 24 h

Secondary outcomes

  1. Normal clinical examination

    Time frame: month 1

    Yes / No

  2. Normal clinical examination

    Time frame: Month 6

    Yes / No

  3. Normal clinical examination

    Time frame: Year 1

    Yes / No

  4. Normal clinical examination

    Time frame: Year 2

    Yes / No

  5. Normal clinical examination

    Time frame: Year 3

    Yes / No

  6. Normal clinical examination

    Time frame: Year 4

    Yes / No

  7. Normal clinical examination

    Time frame: Year 5

    Yes / No

  8. urinary output

    Time frame: Month 1

    ml/s

  9. urinary output

    Time frame: Month 6

    ml/s

  10. urinary output

    Time frame: year 1

    ml/s

  11. urinary output

    Time frame: year 2

    ml/s

  12. urinary output

    Time frame: year 3

    ml/s

  13. urinary output

    Time frame: year 4

    ml/s

  14. urinary output

    Time frame: year 5

    ml/s

  15. Volume of urine

    Time frame: month 1

    ml

  16. Volume of urine

    Time frame: month 6

    ml

  17. Volume of urine

    Time frame: year 1

    ml

  18. Volume of urine

    Time frame: year 2

    ml

  19. Volume of urine

    Time frame: year 3

    ml

  20. Volume of urine

    Time frame: year 4

    ml

  21. Volume of urine

    Time frame: year 5

    ml

  22. Post-void residual urine volume

    Time frame: Month 1

    ml

  23. Post-void residual urine volume

    Time frame: Month 6

    ml

  24. Post-void residual urine volume

    Time frame: year 1

    ml

  25. Post-void residual urine volume

    Time frame: year 2

    ml

  26. Post-void residual urine volume

    Time frame: year 3

    ml

  27. Post-void residual urine volume

    Time frame: year 4

    ml

  28. Post-void residual urine volume

    Time frame: year 5

    ml

  29. cystoscopy

    Time frame: Month 1

    Yes / No

  30. cystoscopy

    Time frame: Month 6

    Yes / No

  31. cystoscopy

    Time frame: year 1

    Yes / No

  32. cystoscopy

    Time frame: year 2

    Yes / No

  33. cystoscopy

    Time frame: year 3

    Yes / No

  34. cystoscopy

    Time frame: year 4

    Yes / No

  35. cystoscopy

    Time frame: year 5

    Yes / No

  36. readjustment of the REMEEX medical device

    Time frame: Month 1

    Yes / No

  37. readjustment of the REMEEX medical device

    Time frame: Month 6

    Yes / No

  38. readjustment of the REMEEX medical device

    Time frame: Year 1

    Yes / No

  39. readjustment of the REMEEX medical device

    Time frame: Year 2

    Yes / No

  40. readjustment of the REMEEX medical device

    Time frame: Year 3

    Yes / No

  41. readjustment of the REMEEX medical device

    Time frame: Year 4

    Yes / No

  42. readjustment of the REMEEX medical device

    Time frame: Year 5

    Yes / No

  43. General improvement of symptoms

    Time frame: 1 month

    Patient Global Impression of Improvement Questionnaire (PGI-I)

  44. General improvement of symptoms

    Time frame: 6 months

    Patient Global Impression of Improvement Questionnaire (PGI-I)

  45. General improvement of symptoms

    Time frame: 1 year

    Patient Global Impression of Improvement Questionnaire (PGI-I)

  46. General improvement of symptoms

    Time frame: 2 years

    Patient Global Impression of Improvement Questionnaire (PGI-I)

  47. General improvement of symptoms

    Time frame: 3 years

    Patient Global Impression of Improvement Questionnaire (PGI-I)

  48. General improvement of symptoms

    Time frame: 4 years

    Patient Global Impression of Improvement Questionnaire (PGI-I)

  49. General improvement of symptoms

    Time frame: 5 years

    Patient Global Impression of Improvement Questionnaire (PGI-I)

  50. Improvement of urinary symptoms

    Time frame: 1 month

    Urinary Symptom Profile Questionnaire (USP)

  51. Improvement of urinary symptoms

    Time frame: 6 months

    Urinary Symptom Profile Questionnaire (USP)

  52. Improvement of urinary symptoms

    Time frame: 1 year

    Urinary Symptom Profile Questionnaire (USP)

  53. Improvement of urinary symptoms

    Time frame: 2 years

    Urinary Symptom Profile Questionnaire (USP)

  54. Improvement of urinary symptoms

    Time frame: 3 years

    Urinary Symptom Profile Questionnaire (USP)

  55. Improvement of urinary symptoms

    Time frame: 4 years

    Urinary Symptom Profile Questionnaire (USP)

  56. Improvement of urinary symptoms

    Time frame: 5 years

    Urinary Symptom Profile Questionnaire (USP)

  57. Side effects or complications

    Time frame: 1 month

  58. Side effects or complications

    Time frame: 6 months

  59. Side effects or complications

    Time frame: 1 year

  60. Side effects or complications

    Time frame: 2 years

  61. Side effects or complications

    Time frame: 3 years

  62. Side effects or complications

    Time frame: 4 years

  63. Side effects or complications

    Time frame: 5 years

  64. Reliability and ease of use of the device

    Time frame: 1 month

  65. Reliability and ease of use of the device

    Time frame: 6 months

  66. Reliability and ease of use of the device

    Time frame: 1 year

  67. Reliability and ease of use of the device

    Time frame: 2 years

  68. Reliability and ease of use of the device

    Time frame: 3 years

  69. Reliability and ease of use of the device

    Time frame: 4 years

  70. Reliability and ease of use of the device

    Time frame: 5 years

  71. Patient incontinence-related quality of life

    Time frame: 1 month

    Incontinence Quality of Life Questionnaire (I-QOL)

  72. Patient incontinence-related quality of life

    Time frame: 6 months

    Incontinence Quality of Life Questionnaire (I-QOL)

  73. Patient incontinence-related quality of life

    Time frame: 1 year

    Incontinence Quality of Life Questionnaire (I-QOL)

  74. Patient incontinence-related quality of life

    Time frame: 2 years

    Incontinence Quality of Life Questionnaire (I-QOL)

  75. Patient incontinence-related quality of life

    Time frame: 3 years

    Incontinence Quality of Life Questionnaire (I-QOL)

  76. Patient incontinence-related quality of life

    Time frame: 4 years

    Incontinence Quality of Life Questionnaire (I-QOL)

  77. Patient incontinence-related quality of life

    Time frame: 5 years

    Incontinence Quality of Life Questionnaire (I-QOL)

  78. Patient sexual-related quality of life

    Time frame: 1 month

    International Index of Erectile Function (IIEF-5) score

  79. Patient sexual-related quality of life

    Time frame: 6 months

    International Index of Erectile Function (IIEF-5) score

  80. Patient sexual-related quality of life

    Time frame: 1 year

    International Index of Erectile Function (IIEF-5) score

  81. Patient sexual-related quality of life

    Time frame: 2 years

    International Index of Erectile Function (IIEF-5) score

  82. Patient sexual-related quality of life

    Time frame: 3 years

    International Index of Erectile Function (IIEF-5) score

  83. Patient sexual-related quality of life

    Time frame: 4 years

    International Index of Erectile Function (IIEF-5) score

  84. Patient sexual-related quality of life

    Time frame: 5 years

    International Index of Erectile Function (IIEF-5) score

  85. Satisfaction of use by the surgeon.

    Time frame: Day 0

    anological visual scale (between 0 and 10)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: Remeex

Important dates

Study start
2016
Primary completion
2028
Study completion
2028
First posted
Aug 28, 2018
Registry last updated
Jun 16, 2026

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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