The Prefyx PPS™ System eRegistry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 5
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
Registry to gather information about the long term use of the Prefyx PPS System for the treatment of Stress Urinary Incontinence (SUI).
详细描述
Registry to gather information about the long term use of the Prefyx PPS System which utilizes a pre-pubic surgical approach (device is to be placed in front of the pubic bone) for the treatment of SUI. No additional procedures are required beyond the physician's standard of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients presenting for treatment of female Urinary Stress Incontinence (SUI)
排除标准
- •Pregnant patients, patients with the potential for future growth or patients that are considering future pregnancies.
- •Any patients with soft tissue pathology into which the implant is to be placed.
- •Patients with any pathology which would compromise implant placement.
- •Patients with any pathology, such as blood supply limitations or infections that would compromise healing.
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 12 months
Adverse events were collected throughout the study and tabulated per severity, seriousness, and device-relatedness.
Number of Participants Who Remain Continent or Improved Following Treatment Through 12 Months Follow-up
时间窗: 12 months
Continence was measured by participant subjective feedback. Responses included: cured, significantly improved, slightly improved, same, slightly worse, or significantly worse
Number of Participants Who Remain Continent or Improved Following Treatment Through 3 Months Follow-up
时间窗: 3 months
Continence was measured by participant subjective feedback. Responses included: cured, significantly improved, slightly improved, same, slightly worse, or significantly worse
Number of Participants Who Report Substantial Improvement and Consider the Surgery Successful, as Measured by the Patient's Global Impression
时间窗: 12 months
Substantial improvement is measured by the participants' subjective feedback of their incontinence if they are cured, improved, same, or worse. Patients' Global Impression measures satisfaction (satisfied, or not satisfied).
次要结局
未报告次要终点