Pilot Study of the ARTUS® Artificial Urinary Sphincter on Women

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Adverse Device Effect Incidence [Срок оценки: 3 months after implantation]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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…)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 2 центра

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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗