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

• Sponsor: Centre Hospitalier Universitaire de Nīmes (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03650244
• Collaborator: (none)
• Enrollment: 150
• Locations: 10
• Anticipated Duration (Months): 83.5
• Patients Per Site: 15
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence,Stress	Device: REMEEX implantation

Study Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Nov 16, 2016
• Anticipated Primary Completion Date: Nov 1, 2023
• Anticipated Study Completion Date: Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients fitted with REMEEX	Device: REMEEX implantation; Device implantation

Outcome Measures

Primary Outcome Measures

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

   PAD test < 2 g / 24 h

2. Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy [6 months]

   PAD test < 2 g / 24 h

3. Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy [1 year]

   PAD test < 2 g / 24 h

4. Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy [2 years]

   PAD test < 2 g / 24 h

5. Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy [3 years]

   PAD test < 2 g / 24 h

6. Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy [4 years]

   PAD test < 2 g / 24 h

7. Evaluate efficacy of REMEEX® on urinary incontinence post radical prostatectomy [5 years]

   PAD test < 2 g / 24 h

Secondary Outcome Measures

1. Normal clinical examination [month 1]

   Yes / No

2. Normal clinical examination [Month 6]

   Yes / No

3. Normal clinical examination [Year 1]

   Yes / No

4. Normal clinical examination [Year 2]

   Yes / No

5. Normal clinical examination [Year 3]

   Yes / No

6. Normal clinical examination [Year 4]

   Yes / No

7. Normal clinical examination [Year 5]

   Yes / No

8. urinary output [Month 1]

   ml/s

9. urinary output [Month 6]

   ml/s

10. urinary output [year 1]

    ml/s

11. urinary output [year 2]

    ml/s

12. urinary output [year 3]

    ml/s

13. urinary output [year 4]

    ml/s

14. urinary output [year 5]

    ml/s

15. Volume of urine [month 1]

    ml

16. Volume of urine [month 6]

    ml

17. Volume of urine [year 1]

    ml

18. Volume of urine [year 2]

    ml

19. Volume of urine [year 3]

    ml

20. Volume of urine [year 4]

    ml

21. Volume of urine [year 5]

    ml

22. Post-void residual urine volume [Month 1]

    ml

23. Post-void residual urine volume [Month 6]

    ml

24. Post-void residual urine volume [year 1]

    ml

25. Post-void residual urine volume [year 2]

    ml

26. Post-void residual urine volume [year 3]

    ml

27. Post-void residual urine volume [year 4]

    ml

28. Post-void residual urine volume [year 5]

    ml

29. cystoscopy [Month 1]

    Yes / No

30. cystoscopy [Month 6]

    Yes / No

31. cystoscopy [year 1]

    Yes / No

32. cystoscopy [year 2]

    Yes / No

33. cystoscopy [year 3]

    Yes / No

34. cystoscopy [year 4]

    Yes / No

35. cystoscopy [year 5]

    Yes / No

36. readjustment of the REMEEX medical device [Month 1]

    Yes / No

37. readjustment of the REMEEX medical device [Month 6]

    Yes / No

38. readjustment of the REMEEX medical device [Year 1]

    Yes / No

39. readjustment of the REMEEX medical device [Year 2]

    Yes / No

40. readjustment of the REMEEX medical device [Year 3]

    Yes / No

41. readjustment of the REMEEX medical device [Year 4]

    Yes / No

42. readjustment of the REMEEX medical device [Year 5]

    Yes / No

43. General improvement of symptoms [1 month]

    Patient Global Impression of Improvement Questionnaire (PGI-I)

44. General improvement of symptoms [6 months]

    Patient Global Impression of Improvement Questionnaire (PGI-I)

45. General improvement of symptoms [1 year]

    Patient Global Impression of Improvement Questionnaire (PGI-I)

46. General improvement of symptoms [2 years]

    Patient Global Impression of Improvement Questionnaire (PGI-I)

47. General improvement of symptoms [3 years]

    Patient Global Impression of Improvement Questionnaire (PGI-I)

48. General improvement of symptoms [4 years]

    Patient Global Impression of Improvement Questionnaire (PGI-I)

49. General improvement of symptoms [5 years]

    Patient Global Impression of Improvement Questionnaire (PGI-I)

50. Improvement of urinary symptoms [1 month]

    Urinary Symptom Profile Questionnaire (USP)

51. Improvement of urinary symptoms [6 months]

    Urinary Symptom Profile Questionnaire (USP)

52. Improvement of urinary symptoms [1 year]

    Urinary Symptom Profile Questionnaire (USP)

53. Improvement of urinary symptoms [2 years]

    Urinary Symptom Profile Questionnaire (USP)

54. Improvement of urinary symptoms [3 years]

    Urinary Symptom Profile Questionnaire (USP)

55. Improvement of urinary symptoms [4 years]

    Urinary Symptom Profile Questionnaire (USP)

56. Improvement of urinary symptoms [5 years]

    Urinary Symptom Profile Questionnaire (USP)

57. Side effects or complications [1 month]

58. Side effects or complications [6 months]

59. Side effects or complications [1 year]

60. Side effects or complications [2 years]

61. Side effects or complications [3 years]

62. Side effects or complications [4 years]

63. Side effects or complications [5 years]

64. Reliability and ease of use of the device [1 month]

65. Reliability and ease of use of the device [6 months]

66. Reliability and ease of use of the device [1 year]

67. Reliability and ease of use of the device [2 years]

68. Reliability and ease of use of the device [3 years]

69. Reliability and ease of use of the device [4 years]

70. Reliability and ease of use of the device [5 years]

71. Patient incontinence-related quality of life [1 month]

    Incontinence Quality of Life Questionnaire (I-QOL)

72. Patient incontinence-related quality of life [6 months]

    Incontinence Quality of Life Questionnaire (I-QOL)

73. Patient incontinence-related quality of life [1 year]

    Incontinence Quality of Life Questionnaire (I-QOL)

74. Patient incontinence-related quality of life [2 years]

    Incontinence Quality of Life Questionnaire (I-QOL)

75. Patient incontinence-related quality of life [3 years]

    Incontinence Quality of Life Questionnaire (I-QOL)

76. Patient incontinence-related quality of life [4 years]

    Incontinence Quality of Life Questionnaire (I-QOL)

77. Patient incontinence-related quality of life [5 years]

    Incontinence Quality of Life Questionnaire (I-QOL)

78. Patient sexual-related quality of life [1 month]

    International Index of Erectile Function (IIEF-5) score

79. Patient sexual-related quality of life [6 months]

    International Index of Erectile Function (IIEF-5) score

80. Patient sexual-related quality of life [1 year]

    International Index of Erectile Function (IIEF-5) score

81. Patient sexual-related quality of life [2 years]

    International Index of Erectile Function (IIEF-5) score

82. Patient sexual-related quality of life [3 years]

    International Index of Erectile Function (IIEF-5) score

83. Patient sexual-related quality of life [4 years]

    International Index of Erectile Function (IIEF-5) score

84. Patient sexual-related quality of life [5 years]

    International Index of Erectile Function (IIEF-5) score

85. Satisfaction of use by the surgeon. [Day 0]

    anological visual scale (between 0 and 10)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Besançon	Besançon		France
2	APHP Hôpital Henry Mondor	Créteil		France	94000
3	CHU de Dijon	Dijon		France
4	CHU de Limoges	Limoges		France
5	CHU Nancy	Nancy		France
6	CHU Nice	Nice		France
7	CHU Nimes	Nîmes		France	30029
8	CHU Strasbourg	Strasbourg		France
9	Hôpital Foch	Suresnes		France	92151
10	CHU Toulouse	Toulouse		France

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nīmes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT03650244
• Other Study ID Numbers: LOCAL/2016/LW-01
• First Posted: Aug 28, 2018
• Last Update Posted: Aug 5, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress

Study Results

No Results Posted as of Aug 5, 2021