Changes in the Quality of Life and Experience of Young Women With Utero-vaginal Aplasia (MRKHPSY)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Evaluation of global quality of life
研究概览
简要总结
This study aims to evaluate the global evolution of the quality of life on patients diagnosed with MRKH syndrome (Mayer-Rokitansky-Kuster-Hauser), 8 to 10 years after the first research.
详细描述
Between 2012 and 2015, the French national reference center for rare gynecological pathologies (PGR) has conducted a study with 2 axis: a medical and a psychological section (clinical trial number NCT01911884).
The medical axis's aim was to compare the global and sexual quality of life of MRKH patients according to the mode of care (surgical or non-surgical) for vaginal aplasia. A total of 131 patients, with a mean age of 26.5 (±5.5) years old, were recruited for the study.
The quality of life was assessed considering 3 quality of life scales: global (WHOQOL-BREF) and sexual (FSFI and FSDS-R).
Quality of life scores and vaginal depth were compared and revealed that the surgery was not superior to self-dilation, whether in terms of quality of life or anatomical results. In addition, surgery was associated with complications in half of the cases. It should be mentioned that the overall quality of life of all 131 patients was similar to that of the general population, but significantly impaired in the psychosocial dimension in the younger patients. Notably, the quality of sexual life was not impaired with FSFI scores similar to those of the general population, but there was a profound sexual distress in nearly 71% of patients according to FSDS-R scores.
The psychological component of this initial research (called T1) focused specifically on the psychological, and more widely on the psychosocial, impact of the diagnosis of utero-vaginal aplasia in adolescent girls. 40 patients out of the 131 in the medical component participated (the first 40 contacted to participate in the medical component research). The results revealed a real experience of disability, and unexpectedly, addictive reactionary disorders (anorexia/bulimia or sport addiction), and an overrepresentation of heterosexual orientation compared to the general population. The absence of a uterus led to severe moral suffering regarding projections of access to biological motherhood.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient aged of 18 years old or older
- •Patient who participated in the initial T1 psychological component of the previous study (MRKH protocol)
- •Exclusion Criteria
- •- Refusal to participate in the study
排除标准
- 未提供
结局指标
主要结局
Evaluation of global quality of life
时间窗: Day 0
Evaluated by the World Health Organization Quality Of Life Brief Version (WHOQOL-BREF)
次要结局
- Socio-professional integration(Day 0)
- Sexual quality of life(Day 0)
- Addictive behavioural disorders(Day 0)
- Desire for motherhood(Day 0)
- The modalities to access to maternity(Day 0)
- Modalities of their psychic functioning(Day 0)