NCT03703843已完成不适用
Feasibility of ARTUS MONO Artificial Urinary Sphincter Implant in Women
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 3
- 主要终点
- Bladder catheterization in presence of ARTUS MONO cuff
研究概览
简要总结
The ARTUS MONO implant is an active implantable medical device (AIMD) that assist the urethral sphincter function of female patients suffering from moderate to severe urinary incontinence, by remotely opening and closing a cuff placed around the bladder neck. The purpose of this clinical investigation is to evaluate the feasibility of implantation of the device, its safety and its efficacy, when temporarily implanted in female patients scheduled for anterior pelvic exenteration for bladder cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- 是
入选标准
- •Female patients aged ≥ 18 yo
- •BMI > 18,5 and < 35
- •Patient scheduled for an anterior pelvic exenteration with ileal conduit urinary diversion
- •Signed informed consent
排除标准
- •Advanced bladder cancer with bladder neck and/or urethral extension
- •Past pelvic radiation therapy
- •Patient previously treated with an artificial urinary sphincter or other urogenital implant
- •Positive urine culture during the past 2 weeks
- •Indwelling bladder catheter during the past 2 weeks
- •Documented history of sensitivity to silicone
- •History of connectivitis disease
- •Immunosuppressive therapy in the last 3 months
- •Vulnerable subjects
- •Participation in any other clinical investigation
研究组 & 干预措施
Active
Experimental
ARTUS MONO
干预措施: ARTUS MONO (Device)
结局指标
主要结局
Bladder catheterization in presence of ARTUS MONO cuff
时间窗: Day 0
Injection then re-aspiration of 50 cc of saline water through 18 Fr Foley catheter
次要结局
- ARTUS MONO cuff implant(Day 0)
- ARTUS MONO cuff activation(Day 0)
研究者
研究点 (3)
Loading locations...
相似试验
进行中（未招募）
不适用
Clinical Investigation to Assess a New Artificial Urinary Sphincter to Treat Urinary Incontinence in WomenUrinary Incontinence,StressNCT05828979UroMems SAS6
进行中（未招募）
不适用
Clinical Investigation to Assess a New Artificial Urinary Sphincter to Treat Urinary Incontinence in MenUrinary Incontinence,StressNCT05547672UroMems SAS6
招募中
4 期
Artificial Urinary Sphincter vs. Adjustable Male Sling for Treating male stress urinary INcontinenceN39.3Stress incontinenceDRKS00015253niversitätsmedizin Mainz270
已完成
不适用
Artificial Urinary Sphincter Clinical OutcomesStress Urinary IncontinenceNCT04088331Boston Scientific Corporation145
已完成
不适用
Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNtUrinary Incontinence, UrgeNCT03327948Axonics, Inc.145