Prospective Study of the Influence on Quality of Life and Sexual Function of the Novasure Endometrial Ablation in the Treatment of Menorrhagia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Quality of life and Sexual Function before, six month and one year after the Novasure Endometrial Ablation
研究概览
简要总结
The aim of this study is to investigate the influence on the quality of life and sexual function before, 6 month and one year after Novasure Endometrial Ablation in the treatment of Menorrhagia.
详细描述
patients diagnosed menorrhagia scheduled for Novasure Endometrial Ablation because of menorrhagia between november, 2012 and november, 2014 are enrolled to this study.
patients are asked to complete preoperative questionnaires considering Health Related Quality of Life questionnaire(HRQoL) and sexual Female Sexual Functioning Index questionnaire(FSFI). Same questionnaires will also be completed six months and one year after operation.
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
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of menorrhagia
- •family complete
- •normal endometrial pathology
- •had not been referred specifically for surgery
- •with normal uterine cavity
排除标准
- •pregnancy or demand to preserve fertility
- •acute reproductive tract inflammation or urinary tract inflammation
- •pathology demonstrate endometrial cancer or precancerous change
- •acute pelvic inflammation
- •intrauterine device(IUD) in uterus
- •depth of uterine cavity less than 4cm or more than 10cm
- •pathologic myometrium( such as history of Hysteromyomectomy or classical cesarean section)
结局指标
主要结局
Quality of life and Sexual Function before, six month and one year after the Novasure Endometrial Ablation
时间窗: one year after Novasure Endometrial Ablation
Quality of life assessed with Health Related Quality of Life questionnaire(HRQoL) before, six month and one year after the Novasure Endometrial Ablation; Sexual Function measured with Female Sexual Functioning Index questionnaire(FSFI) before, six month and one year after the Novasure Endometrial Ablation
次要结局
未报告次要终点
研究者
Shu-Qin Chen
associate professor of gynaecology and obstetrics
First Affiliated Hospital, Sun Yat-Sen University