NCT04558762Unknown不适用
Ten Years Follow-up, Efficacy and Complications, After Insertion of a MUS Due to Stress Urinary Incontinence, According to the Swedish National Quality Register of Gynecological Surgery.
Stockholm South General Hospital1 个研究点 分布在 1 个国家目标入组 15,000 人开始时间: 2020年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15,000
- 试验地点
- 1
- 主要终点
- Stress urinary incontinence
研究概览
简要总结
The investigators intend to investigate the long-term complications and the subjective well-being among women who underwent insertion of a MUS due to stress urinary incontinence 2006-2010.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Underwent a MUS in Sweden 2006-2010 due to stress urinary incontinence.
- •Were registered in The Swedish National Quality Register of Gynecological Surgery.
排除标准
- •Did not undergo MUS surgery in Sweden 2006-2010 due to stress urinary incontinence, except those constituting the control group.
结局指标
主要结局
Stress urinary incontinence
时间窗: +10 years after surgery
We will measure the percentage of women who suffer from a subjective feeling of stress urinary incontinence ten years after surgery. We will use validated scales; UDI-6 ( Urogenital Distress Inventory), IIQ-7 (Incontinence Impact Questionnaire).
次要结局
- Number of participants with dyspareunia(+10 years after surgery)
- Number of participants that has had a reoperation(Up to 14 years after first surgery)
- Number of participants with late post operative complications(+10 years after surgery)
- Number of patients with pelvic pain(+10 years after surgery)
- Number of participants with groin pain(+10 years after surgery)
研究者
Marion Ek
Senior Consultant
Stockholm South General Hospital
研究点 (1)
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