Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse: The Extended Colpopexy and Urinary Reduction Efforts (E-CARE) Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 215
- 试验地点
- 8
- 主要终点
- Number of Participants With Symptomatic Failure
研究概览
简要总结
The Colpopexy and Urinary Reduction Effort (CARE) trial is a research study designed to evaluate whether the addition of a second surgical procedure in addition to a procedure for female pelvic organ prolapse (POP) affects the rates of urinary incontinence. This study will follow women in the CARE study for 10 years from the time of the surgery to compare success and complication rates in the two groups. Recruitment into this study is open only to women that already participated in CARE. Recruitment into CARE is closed.
详细描述
The primary aims of this prospective cohort study are:
- To determine the long-term (up to 10 years) anatomic success rate of sacrocolpopexy (defined as Stage 0 apical prolapse AND <= Stage 2 anterior and posterior prolapse AND no re-operation or pessary treatment for POP), and whether anatomic success differs between women who had vs. those who did not have concomitant Burch colposuspension at the time of sacrocolpopexy;
- To determine whether there is a difference in long-term stress continence (by symptoms) between women who had vs. those who did not have concomitant Burch colposuspension at the time of sacrocolpopexy;
- To determine whether there is a long-term difference between overall pelvic floor symptoms and pelvic-floor specific quality of life between women who had vs. those who did not have concomitant Burch colposuspension at the time of sacrocolpopexy.
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
- •Women enrolled in CARE
排除标准
- •Inability to provide informed consent.
- •Subjects who, at the time of enrollment into E-CARE, are long-term residents of a skilled nursing facility (that is, residency is not limited to short-term rehabilitation).
结局指标
主要结局
Number of Participants With Symptomatic Failure
时间窗: 7 year
Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery
Number of Participants With Anatomic Failure (Original Definition)
时间窗: 7 year
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends \>= 2 cm, or the anterior or posterior vaginal wall decends \>1 cm beyond the hymen
Number of Participants With Anatomic Failure (Updated Definition)
时间窗: 7 year
Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen
Number of Participants With Composite Failure
时间窗: 7 year
Anatomic failure (updated definition) or symptomatic failure
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index
时间窗: 7 year
Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.
Number of Participants With Stress Urinary Incontinence (SUI) Prevention
时间窗: 7 year
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI
Number of Participants With Stress Urinary Incontinence (SUI)
时间窗: 7 year
One or more SUI symptoms reported on the Pelvic Floor Distress Inventory
次要结局
未报告次要终点