NCT01115465Unknown不适用
Real-time Observation of Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 276
- 试验地点
- 38
- 主要终点
- To describe the incidence of additional or alternative treatment for stress urinary incontinence due to ISD following up to two Macroplastique treatments over a 5 year period.
研究概览
简要总结
The ROSE Registry will determine the long-term safety and effectiveness of Macroplastique in the treatment of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD).
详细描述
The Rose Registry is a five-year post-market study of the safety and effectiveness of Macroplastique in the treatment of female stress urinary incontinence due to intrinsic sphincter deficiency.
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
- •Subject has signed written informed consent
- •Subject is a female at least 18 years of age
- •Subject has been diagnosed with SUI primarily due to intrinsic sphincter deficiency (ISD)
- •Subject understands all study requirements including five year follow-up schedule
- •Subject is psychologically stable and suitable for intervention as determined by the Investigator
排除标准
- •Subject has an acute urogenital tract inflammation or infection
- •Subject is pregnant or intends to become pregnant within one year
- •Subject has had a sling placement within 12 weeks
- •Subject has had a bulking agent treatment within 12 weeks
- •Subject has a bladder neck or urethral stricture, gross utero-vaginal prolapse, untreated detrusor instability or hyperreflexia, neuropathic bladder, or overflow incontinence
结局指标
主要结局
To describe the incidence of additional or alternative treatment for stress urinary incontinence due to ISD following up to two Macroplastique treatments over a 5 year period.
时间窗: 5-years
To describe the incidence of additional or alternative treatments
次要结局
- To describe the incidence of genitourinary and treatment related adverse events, including transient symptoms associated with the injection procedure.(5-years)
研究者
研究点 (38)
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