DRKS00032443招募中不适用
Prospective observational study to evaluate the efficacy and safety of laparoscopic bilateral uterosacropexy with DynaMesh®-CESA and VASA mesh implants in women with pelvic organ prolapse - Pro-USA-AWB
Frauenklinik der Universität zu Köln0 个研究点目标入组 163 人开始时间: 2023年8月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 163
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one(—)
- 性别
- Female
入选标准
- •Impaired by pelvic organ prolaps symptoms >4 (according to the Numerical Rating Scale (NRS) score from 0-10, where 0 = not affected to 10 = severely affected)
- •Signed declaration of consent including authorization for data processing
- •Women of childbearing potential with adequate contraceptive protection. Safe contraceptive measures are considered (Pearl Index < 1%):
排除标准
- •Serious, life-threatening and/or active malignancy
- •Congenital uterine anomalies
- •Conspicuous PAP smears or evidence of CIN II/III or unexplained postmenopausal bleeding
- •Surgical pre-treatment for descensus uteri
- •Existing or planned pregnancy: In patients of childbearing age, pregnancy must be ruled out by means of a pregnancy test or other suitable methods.
研究者
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