Safety and Clinical Performance Study of the ARTUS® Artificial Urinary Sphincter (AUS) (DRY)

Myopowers Medical Technologies

Status: Not yet enrolling

Conditions: Stress Urinary Incontinence

Treatments: Device: Artificial Urinary Sphincter implantation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04827199

CIV-CZ-22-01-038768 (Other Identifier)

DRY

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

70 participants in 1 patient group

ARTUS®

Experimental group

Description:

The subjects will be implanted with the experimental medical device ARTUS® Artificial Urinary Sphincter (AUS) during the surgical procedure and will be trained to the use of the Remote Control to control themselves the micturition.

Treatment:

Device: Artificial Urinary Sphincter implantation