Clinical trial NCT04827199: Safety and Clinical Performance Study of the ARTUS® Artificial Urinary Sphincter (AUS)
Official title: Safety and Clinical Performance Study of the ARTUS® Artificial Urinary Sphincter (AUS) for the Treatment of Stress Urinary Incontinence (SUI) Due to Intrinsic Sphincter Deficiency
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Artificial Urinary Sphincter
Lead sponsor: Myopowers Medical Technologies France SAS
Sponsor class: INDUSTRY
Collaborators: name: EVAMED
name: Affluent Medical
First posted: 2021-04-01
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The subjects will be implanted with the ARTUS® medical device and then be followed up for 10 years post-implant, with the primary endpoints measured at 3-month post-device activation visit.

As there is no comparator, there is no randomization and no blinding in the study.

Clinical performance outcomes will be measured for each subject at baseline (before implantation) and post-implantation.
Primary purpose: TREATMENT

Brief summary: This clinical investigation is designed as an interventional, prospective, non-randomized, open-label, single arm, multicentric and international study for obtaining CE marking.

The study will be the first performed with the ARTUS® medical device aiming to assess safety and performance and will be composed of three phases:

* pilot phase (with safety analysis on the 10 first included subjects in 3 investigational sites),
* pivotal phase (in up to 16 investigational sites with a follow-up until the 12-month post-device activation visit, including an interim analysis at 3-month post-device activation visit on performance and safety),
* long-term phase (with a long-term follow-up until 10 years post implantation in up to 16 investigational sites).

The objectives is to assess safety and clinical performance of the ARTUS® for the treatment of Stress Urinary Incontinence at short and long-term.


Eligibility criteria: Inclusion Criteria:

1. Male subject between 18 and 80 years (inclusive) of age at the time of consent signature
2. Subject with persistent urinary incontinence, defined as \>12 months
3. Subject with severe Stress Urinary Incontinence, defined as a mean value of 3 consecutive 24-hour Pad Weight Test \> 75 grams
4. Subject willing and able to provide written informed consent
5. Subject willing and able to comply with all clinical study requirements, including the ability to independently operate the device remote control
6. Subject willing and able to comply with follow-up visits
7. Subject having understood and accepted to be unable to proceed to an MRI examination after the surgical procedure due to the non-MRI compatibility of the device
8. Subject having signed the informed consent

Exclusion Criteria:

1. Subject with documented neurological bladder or history of neurological disease liable to interfere with urinary symptoms
2. Subject with history of Artificial Urinary Sphincter or male sling implantation
3. Subject with history of pelvic radiotherapy
4. Subject with history of Artificial Urinary Sphincter-related urethral erosion
5. Subject with history of urethral fistula
6. Subject with history of bladder tumour
7. Subject with severe urethral stenosis
8. Subject with urge incontinence due to hyperactive bladder not adequately controlled by drug therapy
9. Subject with severe congenital or acquired haemorrhagic disease, haemophilia, or another coagulopathy
10. Subject under anti-coagulation or anti-platelet medication that cannot be discontinued at least 5 days prior to surgery and restarted at least 5 days after surgery
11. Subject with currently active infection, including urinary tract infection
12. Subject with severe renal failure or obstructive pathologies of the upper urinary tract with severe renal failure
13. Subject with a current vesicourethral reflux
14. Subject with congenital or acquired immunodeficiency, including those who are immunocompromised or immunosuppressed
15. Subject with bladder or urethral foreign body or calculus
16. Subject with allergy to any components of the device
17. Subject deprived of liberty by administrative or judicial decision or under legal guardianship
18. Subject having a Body Mass Index (BMI) \> 40
19. Subject with post void residual volume greater than 200 mL, within the past 6 months
20. Subject with uncontrolled diabetes, defined as HbA1c \> 9.0%, within the past 6 months
21. Subject with history of recurrent bladder stones or history of failed bladder stone treatment within the past 12 months
22. Subject currently enrolled or plans to participate in another investigational study of a drug, biologic, or medical device from the point of enrolment through the 12 months post device activation period
23. Subject who underwent any surgical procedure in the last 3 months, or with planned surgical procedure within the next 3 months
24. Subject who is unwilling or deemed by the Investigator to be unwilling to comply with the Clinical Investigation Plan, or subject with a history of non-compliance
25. Subject unable to understand and sign the ICF in absence of legal representative
26. Subject with a lack of capacity to consent
27. Subject unable to read and write
28. Subject in emergency situation

Primary outcomes:
measure: Change in the 24-hour Pad Weight Test
timeFrame: 3 months post-device activation
Secondary outcomes:
measure: Adverse events (including adverse device effect) occurred from the implantation to the 10-year follow-up period
timeFrame: Implantation, 6 weeks, 8 weeks and 3 months post-op, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
measure: Revision rate
timeFrame: Implantation, 6 weeks, 8 weeks and 3 months post-op, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
measure: Explantation rate
timeFrame: Implantation, 6 weeks, 8 weeks and 3 months post-op, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
measure: Renal function
timeFrame: Baseline, Implantation, discharge, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
measure: Pain assessed by numeric rating scale
timeFrame: Implantation, 6 weeks, 8 weeks and 3 months post-op, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
measure: Voided urine assessed with uroflowmetry
timeFrame: Baseline, 3, 6 and 12-month post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
measure: Voided volume assessed with uroflowmetry
timeFrame: Baseline, 3, 6 and 12-month post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
measure: Maximum flow rate assessed with uroflowmetry
timeFrame: Baseline, 3, 6 and 12-month post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
measure: Bladder drainage
timeFrame: Baseline, 3, 6 and 12-month post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
measure: Usability assessed by a 5-point scale
timeFrame: Implantation
measure: Device deficiencies occurred from the implantation to the 10-year follow-up period
timeFrame: Implantation, 6 weeks, 8 weeks and 3 months post-op, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
measure: Change in the 24-hour Pad Weight Test
timeFrame: Baseline, 3, 6 and 12-month post-device activation
measure: Reduction in the 24-hour Pad Weight Test
timeFrame: Baseline, 6 and 12-month post-device activation
measure: Pad Usage
timeFrame: Baseline, 3, 6, and 12-month post-device activation visit,2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
measure: Urinary symptoms assessed with ICIQ-MLUTS subscales
timeFrame: Baseline, 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
measure: Urinary incontinence Quality of Life assessed with ICIQ-LUTSQoL questionnaire
timeFrame: Baseline, 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
measure: General Quality of Life assessed with EQ-5D-5L questionnaire
timeFrame: Baseline, 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
measure: Sexual Quality of Life assessed with the Male Sexual Health Questionnaire (MHSQ)
timeFrame: Baseline, 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
measure: Subject usability assessed by a 5-point scale
timeFrame: 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
measure: Subject satisfaction assessed by the PGI-I
timeFrame: 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
measure: Subject satisfaction assessed by 5-point scale
timeFrame: 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
measure: Subject recommendation assessed by 5-point scale
timeFrame: 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
measure: Investigator usability assessed by a 5-point scale
timeFrame: Device activation visit (6 weeks post-operative visit), 3 months post-device activation
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Thomayer hospital
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Badalona
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
Study officials:
affiliation: Thomayerova nemocnice
name: Roman Zachoval, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Myopowers Medical Technologies France SAS
name: Marion Melot
role: STUDY_DIRECTOR
References: