NCT01673360终止不适用
Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 401
- 试验地点
- 19
- 主要终点
- Prolapse Efficacy - POP-Q
研究概览
简要总结
To monitor post-market performance through evaluation of short and long-term performance via:
- Efficacy
- Safety
- Patient reported outcomes
详细描述
As this is a post-market registry on market approved devices, there will be no formal hypothesis testing. However, points of evaluation will include:
- Characterize the efficacy of the AMS market approved female pelvic health products using standard of care outcome measures and validated quality of life questionnaires
- Characterize the type, severity, and rate of adverse events related to each AMS market approved female pelvic health product
- Collect concomitant procedural data related to the pelvic floor area
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following criteria to be considered for inclusion in the registry.
- •Have a signed Informed Consent Form
- •Have a signed HIPAA Authorization Form or equivalent Patient Privacy Form if required outside of the US
- •Is a female at least 18 years of age
- •Is scheduled to receive at least one (1) AMS market approved female pelvic health implantable product.
- •Is able and willing to participate in the registry
排除标准
- •Patients will be excluded from the registry if any one of the following criteria is met.
- •Patients are contraindicated to receive the target AMS market approved female pelvic health product per the product's IFU
结局指标
主要结局
Prolapse Efficacy - POP-Q
时间窗: annually, upto 5 years
Prolapse Endpoints: • POP-Q measurement
Urinary Incontinence Endpoints
时间窗: annually upto 5 years
Urinary Incontinence Endpoints: * Cough stress test * 1 hour pad weight test * Urodynamics
次要结局
未报告次要终点
研究者
研究点 (19)
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