Status:
NOT_YET_RECRUITING
Safety and Clinical Performance Study of the ARTUS® Artificial Urinary Sphincter (AUS)
Lead Sponsor:
Myopowers Medical Technologies France SAS
Collaborating Sponsors:
EVAMED
Affluent Medical
Conditions:
Stress Urinary Incontinence
Eligibility:
MALE
18-80 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Male subject between 18 and 80 years (inclusive) of age at the time of consent signature
- Subject with persistent urinary incontinence, defined as \>12 months
- Subject with severe Stress Urinary Incontinence, defined as a mean value of 3 consecutive 24-hour Pad Weight Test \> 75 grams
- Subject willing and able to provide written informed consent
- Subject willing and able to comply with all clinical study requirements, including the ability to independently operate the device remote control
- Subject willing and able to comply with follow-up visits
- 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
- Subject having signed the informed consent
Exclusion
- Subject with documented neurological bladder or history of neurological disease liable to interfere with urinary symptoms
- Subject with history of Artificial Urinary Sphincter or male sling implantation
- Subject with history of pelvic radiotherapy
- Subject with history of Artificial Urinary Sphincter-related urethral erosion
- Subject with history of urethral fistula
- Subject with history of bladder tumour
- Subject with severe urethral stenosis
- Subject with urge incontinence due to hyperactive bladder not adequately controlled by drug therapy
- Subject with severe congenital or acquired haemorrhagic disease, haemophilia, or another coagulopathy
- 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
- Subject with currently active infection, including urinary tract infection
- Subject with severe renal failure or obstructive pathologies of the upper urinary tract with severe renal failure
- Subject with a current vesicourethral reflux
- Subject with congenital or acquired immunodeficiency, including those who are immunocompromised or immunosuppressed
- Subject with bladder or urethral foreign body or calculus
- Subject with allergy to any components of the device
- Subject deprived of liberty by administrative or judicial decision or under legal guardianship
- Subject having a Body Mass Index (BMI) \> 40
- Subject with post void residual volume greater than 200 mL, within the past 6 months
- Subject with uncontrolled diabetes, defined as HbA1c \> 9.0%, within the past 6 months
- Subject with history of recurrent bladder stones or history of failed bladder stone treatment within the past 12 months
- 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
- Subject who underwent any surgical procedure in the last 3 months, or with planned surgical procedure within the next 3 months
- 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
- Subject unable to understand and sign the ICF in absence of legal representative
- Subject with a lack of capacity to consent
- Subject unable to read and write
- Subject in emergency situation
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2034
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04827199
Start Date
December 1 2022
End Date
December 1 2034
Last Update
September 19 2022
Active Locations (3)
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1
Thomayer hospital
Prague, Czechia
2
Hospital Germans Trias i Pujol
Barcelona, Badalona, Spain, 08916
3
Hospital Clinico San Carlos
Madrid, Spain, 28040