NCT02998216Unknown不适用
Pelvic Floor Symptoms and Patients´ Satisfaction After Bilateral Sacrospinous Fixation for the Primary Treatment of Pelvic Organ Prolapse ICS-POPQ Stage IV: A Prospective Observational Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Assessment of pelvic floor symptoms
研究概览
简要总结
This study aims to the assessment of pelvic floor symptoms and patients´ satisfaction after bilateral sacrospinous fixation for the primary treatment of pelvic organ prolapse stage IV.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age 18 and above
- •pelvic organ prolapse ICS-POPQ Stage IV, with or without uterus
- •signed informed consent
排除标准
- •gynecologic surgery in the three past months before planned surgery
- •history of prolapse surgery
- •participation in another study
- •need to simultaneously perform other surgical procedures (i.e. rectopexy)
- •ongoing chemotherapy of treatment with immunosuppressant drugs
结局指标
主要结局
Assessment of pelvic floor symptoms
时间窗: Twelve months
Using the validated Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004)
次要结局
- Anatomical outcome / Prolapse stage after surgery(Twelve months)
- Changes in quality of life(Twelve months)
- Changes in sexual activity(Twelve months)
研究者
研究点 (1)
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