The Prolapse Registry: An Observational Collection of Short- and Long-Term Patient Outcomes Following Use of AMS Surgical Devices for the Repair of Female Genital Prolapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,543
- 试验地点
- 1
- 主要终点
- Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device
研究概览
简要总结
This registry was observational (only collected information typically noted by the surgeon when their patients were routinely seen); there was no change to the care the patient received as a result of being part of the registry). Data collection focused on the surgical outcomes of AMS prolapse products.
详细描述
The Prolapse Registry was an observational study of patients who were implanted with AMS devices for the surgical repair of female pelvic prolapse. The registry followed patients post-operatively for up to 2 years and collected demographic, clinical, surgical, safety, and patient outcomes data.
The registry was a web-based system in which surgeons entered patient information with regard to their prolapse surgery. All information entered was de-identified (no names, no date of birth, no date of surgery, etc).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female at least 21 years old
- •Has pelvic organ prolapse requiring surgical repair
- •Receives at least one of the AMS Prolapse Repair devices in the treatment of their pelvic organ prolapse
排除标准
- •Is contraindicated for an AMS Prolapse Repair per the product's Instruction for Use.
结局指标
主要结局
Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device
时间窗: up to 2-years post-implant
次要结局
- Prolapse Efficacy Success Rate(24 months)