NCT07641218尚未招募不适用
Pilot Clinical Investigation of the ARTUS® Artificial Urinary SPHincter (AUS) for the Treatment of Stress UrInary iNcontinence (SUI) in Women
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 6
- 试验地点
- 2
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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…)
研究者
研究点 (2)
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