NCT04827199尚未招募不适用
Safety and Clinical Performance Study of the ARTUS® Artificial Urinary Sphincter (AUS) for the Treatment of Stress Urinary Incontinence (SUI) Due to Intrinsic Sphincter Deficiency
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 5
- 主要终点
- Change in the 24-hour Pad Weight Test
研究概览
简要总结
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.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in the 24-hour Pad Weight Test
时间窗: 3 months post-device activation
Proportion of subjects with at least 50% reduction in 24-hour Pad Weight Test at 3 months post-device activation compared to baseline.
次要结局
- Revision rate(Implantation, 6 weeks, 8 weeks and 3 months post-op, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op)
- Explantation rate(Implantation, 6 weeks, 8 weeks and 3 months post-op, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op)
- Usability assessed by a 5-point scale(Implantation)
- Maximum flow rate assessed with uroflowmetry(Baseline, 3, 6 and 12-month post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op)
- Device deficiencies occurred from the implantation to the 10-year follow-up period(Implantation, 6 weeks, 8 weeks and 3 months post-op, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op)
- Change in the 24-hour Pad Weight Test(Baseline, 3, 6 and 12-month post-device activation)
- Subject usability assessed by a 5-point scale(3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op)
- Subject satisfaction assessed by 5-point scale(3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op)
- Investigator usability assessed by a 5-point scale(Device activation visit (6 weeks post-operative visit), 3 months post-device activation)
- Adverse events (including adverse device effect) occurred from the implantation to the 10-year follow-up period(Implantation, 6 weeks, 8 weeks and 3 months post-op, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op)
- Renal function(Baseline, Implantation, discharge, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op)
- Pain assessed by numeric rating scale(Implantation, 6 weeks, 8 weeks and 3 months post-op, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op)
- Voided volume assessed with uroflowmetry(Baseline, 3, 6 and 12-month post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op)
- Bladder drainage(Baseline, 3, 6 and 12-month post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op)
- Reduction in the 24-hour Pad Weight Test(Baseline, 6 and 12-month post-device activation)
- Voided urine assessed with uroflowmetry(Baseline, 3, 6 and 12-month post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op)
- Pad Usage(Baseline, 3, 6, and 12-month post-device activation visit,2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op)
- Urinary symptoms assessed with ICIQ-MLUTS subscales(Baseline, 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op)
- Urinary incontinence Quality of Life assessed with ICIQ-LUTSQoL questionnaire(Baseline, 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op)
- Subject satisfaction assessed by the PGI-I(3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op)
- Subject recommendation assessed by 5-point scale(3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op)
- General Quality of Life assessed with EQ-5D-5L questionnaire(Baseline, 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op)
- Sexual Quality of Life assessed with the Male Sexual Health Questionnaire (MHSQ)(Baseline, 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op)
研究者
研究点 (5)
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