Pilot Study of the ARTUS® Artificial Urinary Sphincter on Women

Official title

Pilot Clinical Investigation of the ARTUS® Artificial Urinary SPHincter (AUS) for the Treatment of Stress UrInary iNcontinence (SUI) in Women

Overview

The subjects will be implanted with the ARTUS® medical device and then be followed up to 2 years post-implantation, with the primary endpoints measured at 3-month post-implantation. Safety and Clinical performance outcomes will be measured for each subject at baseline (before implantation) and post-implantation.

Interventions

• Device Artificial Urinary Sphincter ARTUS
  The subjects will be implanted by the ARTUS Artificial Urinary Sphincter (AUS). The device will be activated 6 weeks after surgery and the tightening will be adjusted by the investigators in order to reach continence.

Primary outcome measures

• Adverse Device Effect Incidence [Time frame: 3 months after implantation]

Secondary outcome measures (12)

• Adverse Events Incidence [Time frame: Day 30, 3 months, 6 months, 12 months and 24 months after implantation]
• Revision Rate [Time frame: 30 days, 3 months, 6 months, 12 months and 24 months after implantation]
• Explantation Rate [Time frame: Day 30, 3 months, 6 months, 12 months and 24 months after implantation]
• Evolution of Renal Function [Time frame: Baseline, Day 1]
• Evolution of the pain [Time frame: Day 1, Day 45, 3 months, 6 months, 12 months and 24 months after implantation]
• Evolution of uroflowmetry [Time frame: Baseline, 3 months after implantation]
• Bladder Drainage [Time frame: Baseline, Day 1, 3 months, 6 months, 12 months and 24 months after implantation]
• Device Deficiency [Time frame: Implantation, Day 1, Day 45, 3 months, 6 months, 12 months, 24 months after implantation]
• Pad Weight Test [Time frame: Baseline, 3 months, 6 months, 12 months and 24 months after implantation]
• Pads Usage [Time frame: Baseline, Day 45, 3 months, 6 months, 12 months and 24 months after -implantation]
• Evolution of Stress Urinary Symptoms [Time frame: Baseline, 3 months, 6 months, 12 months and 24 months after implantation]
• Evolution of Urinary Symptoms [Time frame: Baseline, 3 months, 6 months, 12 months, 24 months after implantation]

Eligibility criteria

Inclusion criteria

• Female subject over 18 years of age at the time of consent signature
• Subject with persistent severe urinary incontinence:

• at least 3 months after failed pelvic floor muscle training OR
• at least 6 months after a failed surgical treatment (e.g. slings)
• Subject with severe Stress Urinary Incontinence, defined as a mean value of 3 consecutive 24-hour Pad Weight Test > 100 grams
• Subject willing and able to provide written informed consent and having signed the informed consent
• 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 a life expectancy ≥ 5 years as assessed by the investigator

Exclusion criteria

• 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 deprived of liberty by administrative or judicial decision or under legal guardianship
• Subject who is unwilling or deemed by the investigator to be unwilling to comply with the clinical study requirements, including attending follow-up visits.
• Subject having inadequate cognitive or capabilities to use the Artus device as assessed by the investigator
• Pregnant subject, or subject willing to be pregnant during the study duration, or subject of child-bearing potential with non-stable medication contraception
• Subject with urge incontinence due to hyperactive bladder not adequately controlled by drug therapy
• Subject with overflow urinary incontinence
• Subject with Significant Neuro-urological disorders: elevated detrusor pressure, Detrusor sphincter desinergy
• Subject with history of pelvic radiotherapy
• Subject with any planned procedure requiring urethral catheterization 12 months after implant procedure (include intermittent catheterization) except for diagnostic purposes
• Subject with known allergy to any components of the device
• Subject with history of Artificial Urinary Sphincter
• 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 having a Body Mass Index (BMI) > 40
• Subject with uncontrolled diabetes, defined as HbA1c > 9.0% within the past 6 months
• Subject with history of urethral fistula
• Subject with history of bladder tumor
• Subject with severe urethral stenosis.
• 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 congenital or acquired immunodeficiency, including those who are immunocompromised or immunosuppressed
• Subject with post void residual volume greater than 200 mL 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 in emergency situation (caused by a sudden life threatening or other sudden serious medical condition including but not limited to heart attack, stroke, coma, epileptic seizure, heavy bleeding, severe pain, trouble breathing…)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

France · 2 centers

• Cochin Hospital, APHP — Paris
• Tenon Hospital, APHP — Paris

Identifiers

NCT: NCT07641218 · SPHIN-X · 2025-A00257-42

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗