Hysterectomy and Levonorgestrel-releasing IUS in the Treatment of Menorrhagia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 236
- 主要终点
- HRQoL (Health Related Quality of Life)
研究概览
简要总结
A randomised study including 236 women referred for essential menorrhagia to five university hospitals in Finland was conducted to compare the cost-effectiveness and the quality of life issues in the treatment of menorrhagia.Participants were randomly assigned to treatment with LNG-IUS (n=119), or hysterectomy (n=117), and were monitored for ten years. The primary outcome measures were health related quality of life (HRQoL), other measures of psychosocial well-being (anxiety, depression, sexual functioning), and costs.
详细描述
A randomized VUOKKO trial was conducted between 1994-2008 to study hysterectomy and LNG-IUS in the treatment of menorrhagia.Overall, 236 women aged 35 to 49 years who were menstruating, had completed their family size, and were eligible for both treatments were randomized to either receive a LNG-IUS (n=119) or undergo hysterectomy (n=117). The follow-up visits took place six months and 12 months after the treatment, and again five and ten years after the randomization. The primary outcome measures were health related quality of life (HRQoL), other measures of psychosocial well-being (anxiety, depression, sexual functioning), and costs. The amount of menstrual blood loss was objectively measured before treatment and after one and five years. The one year the results were published in 2001 (Lancet 2001;357:273) and the five year results in 2004 (JAMA 2004; 291:1456).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •heavy menstrual bleeding
- •35-49 years
- •were menstruating
- •had completed their family size
- •were eligible for both treatments
排除标准
- •submucous fibroids
- •endometrial polyps
- •ovarian tumours or cysts,
- •cervical pathology
- •urinary and bowel symptoms or pain due to large fibroids
- •lack of indication for hysterectomy
- •history of malignancies
- •menopause
- •severe depression
- •metrorrhagia as a main complaint
- •previous treatment failure with LNG-IUS
- •severe acne
- •uterine malformation
研究组 & 干预措施
LNG-IUS
Levonorgestrel releasing intrauterine system
干预措施: LNG-IUS (Drug)
LNG-IUS
Levonorgestrel releasing intrauterine system
干预措施: Hysterectomy (Procedure)
Hysterectomy
Hysterectomy
干预措施: LNG-IUS (Drug)
Hysterectomy
Hysterectomy
干预措施: Hysterectomy (Procedure)
结局指标
主要结局
HRQoL (Health Related Quality of Life)
时间窗: baseline and 5 years
HRQoL was measured by the 5-Dimensional EuroQol (EQ-5D) questionnaire which measures HRQoL in 5 dimensions of life (scale 0-1)(from very poor=0 to very good=5). The results are the change of HRQoL from baseline at 5 years (EQ-5D score at 5 years - EQ-5D score at baseline)
Costs
时间窗: baseline, 6 and 12 months, 5 and 10 years
次要结局
- Depression(baseline, 6 and 12 months, 5 and 10 years)