Real-time Observation of Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 入组人数
- 276
- 试验地点
- 19
- 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
研究组 & 干预措施
Macroplastique
Macroplastique will be used for the treatment in an open-label, five year, post-market study
干预措施: Macroplastique (Device)
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)