NCT05547672进行中（未招募）不适用
First-in-human Study to Assess the UrOMems Artificial Urinary sPHincter In the treAtment of Stress Incontinence
UroMems SAS2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2022年8月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Rate of device activation successes
研究概览
简要总结
Prospective multicenter study designed to test the feasibility of the UroMems Artificial Urinary Sphincter.
详细描述
This study is a prospective, open-label, non-randomized, multi-center, single-arm, study with subjects acting as their own control designed to test the feasibility of a new artificial urinary sphincter the UroMems eAUS (investigational name of device called UroActive).
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Aged >18 years old
- •Male patient
- •Cognitively able and willing to sign an informed consent
- •Stable medication regimen (including prescription, over the counter, and supplements) for the past 3 months
- •Able and willing to comply with follow-up investigations, including maintaining consistent medication use and fluid intake through the primary endpoints
- •Has adequate cognitive and manual capabilities to operate the UroMems eAUS System as assessed by the investigator
- •Is an appropriate surgical candidate and has no medical or mental condition that would interfere with study procedures or confound study outcomes as assessed by the investigator
- •Life expectancy ≥ 5 years as assessed by the investigator
- •Affiliated with an appropriate social security system
- •Has failed or is not a candidate for other treatments for urinary incontinence, either surgical or conservative, including slings, Pro-ACT, etc. (excluding other AUS devices)
- •Negative urine culture prior to the procedure
- •Urinary incontinence assessed by investigator with at least ≥ 50 g in 24-hour pad-weight tests
- •Clinically insignificant post-void residual (PVR) urine defined as < 50 ml and/or no greater than 10% of the voided volume
- •Complains of urine leakage on coughing, laughing, and/or moving and/or presence of orthostatic urine leakage by self-report as recorded in baseline bladder diary
排除标准
- •Currently enrolled or plans to enroll in another investigational device or clinical drug trial or has completed an investigational study within 3 months
- •Vulnerable patient (patient deprived of their liberty due to a judicial or administrative decision, patient suffering from psychiatry troubles preventing him from giving his consent, patients hospitalized for reason other than the current clinical investigation, patient under 18 years of age, patient under tutelage, patient having withdrawn his consent)
- •Patients whom the investigator determines to be poor candidate for surgical procedures and/or anesthesia due to physical or mental conditions
- •Patient presenting one or several contraindications of the device
- •Any planned procedure requiring urethral catheterization 12 months after implant procedure (include intermittent catheterization) except for diagnostic purposes
- •Known allergy to UroMems eAUS implantable components
- •Known allergy to intravenous iodine
- •Abnormal Prostate Screening Antigen (PSA), according to site's laboratory standards, unless further investigation confirms the absence of primary prostate cancer or local recurrence assessed by investigator.
- •Uncontrolled diabetes mellitus defined as persistent blood sugar level recordings of >12 mmol/l (216 mg/dl) and a glycosylated hemoglobin (HbA1C) of >9% (75 mmol/mol) over the preceding 3 months
- •History of bleeding diathesis or cannot stop usage of an anti-coagulant until the International Normalized Ratio (INR) is below 1.5 or quick value >70
- •Any genito-urinary malignancies which are not in remission for at least 2 years or considered cured, except prostate cancer
- •Previous AUS implant
- •Currently has another Active Implantable Medical Device (AIMD) implanted
- •Urge incontinence, mixed incontinence (MI) with a predominant urgency component
- •Overflow urinary incontinence
- •Neurogenic bladder dysfunction that is not treatable or controllable by pharmacological or any alternative methods
- •Abnormal or poor bladder compliance defined as being <30 ml/ cm H2O
- •Bladder neck or urethral stricture that may require any long-term instrumental treatment
结局指标
主要结局
Rate of device activation successes
时间窗: 5 weeks after device implantation
Rate of device activation successes
Rate of explants and revisions at 6 months after device activation
时间窗: 6 months after device activation
Rate of explants and revisions
次要结局
- Number of subjects with 50% reduction or greater in 24-hour pad weight test(90, 185 days and annually up to 5-years after activation)
- Number of subjects with 75% reduction or greater in 24-hour pad weight test(90, 185 days and annually up to 5-years after activation)
- 3-day bladder diary(90, 185 days and annually up to 5-years after activation)
- General quality of life questionnaire(90, 185 days and annually up to 5-years after activation)
- Disease specific questionnaire (level of incontinence)(90, 185 days and annually up to 5-years after activation)
- Disease specific questionnaire (symptoms and quality of life)(90, 185 days and annually up to 5-years after activation)
- Disease specific questionnaire (sexual activity)(90, 185 days and annually up to 5-years after activation)
- Disease specific questionnaire (quality of life)(90, 185 days and annually up to 5-years after activation)
- Disease specific questionnaire (type of incontinence)(90, 185 days and annually up to 5-years after activation)
- Post void residuals(Baseline, within 45 days after baseline (device implantation), 14 days after implantation, 5 weeks after implantation (device activation), and 14, 30, 90, 185 days and annually up to 5-years after activation)
- Patient satisfaction(5 weeks after device implantation (device activation), and 14, 30, 90, 185 days and annually up to 5-years after activation)
- Physician satisfaction questionnaire(Within 45 days after baseline (device implantation), 5 weeks after implantation (device activation), and 14, 30, 90, 185 days and annually up to 5-years after activation)
- Rate of adverse events(Baseline, within 45 days after baseline (device implantation), 14 days after implantation, 5 weeks after implantation (device activation), and 14, 30, 90, 185 days and annually up to 5-years after activation)
研究者
研究点 (2)
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