Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12,234
- 主要终点
- Number of uterine fibroids patients who experience new or recurrent symptoms after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation)
研究概览
简要总结
The purpose of this observational, retrospective database study of patients with uterine fibroids is to compare the durability of symptom relief after uterus-conserving treatments for symptomatic fibroids in terms of incidence of, and time to, new or recurrent symptoms and subsequent procedures and evaluate the effect stakeholder participation had on the research process.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 54 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with a diagnosis of uterine fibroids at any time and at least 1 office visit during study time period
- •At least 1 of the procedures of interest occurring between January 1, 2005 - December 31, 2011
- •≥ 18 years and < 55 years of age at the index date
排除标准
- •Patients with a diagnosis of gynecologic cancer (ovarian, uterine, cervical)
- •First recorded diagnosis of uterine fibroids occurring beyond four weeks after the Index Date ONLY for patients who underwent endometrial ablation or hysterectomy
- •Patients with a record of any procedures of interest occurring before January 1, 2005
结局指标
主要结局
Number of uterine fibroids patients who experience new or recurrent symptoms after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation)
时间窗: Minimum of two years after index procedure
Time to new or recurrent symptoms after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation)
时间窗: Minimum of two years after index procedure
Number of uterine fibroids patients who experience a subsequent procedure after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation)
时间窗: Minimum of two years after index procedure
Time to a subsequent procedure after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation)
时间窗: Minimum of two years
Effect of stakeholder participation in the research process
时间窗: From first stakeholder conference (April 2014) to final stakeholder conference (November 2015)
次要结局
未报告次要终点
研究者
Priscilla Velentgas
Senior Director of Epidemiology and Health Outcomes
Quintiles, Inc.