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临床试验/DRKS00032443
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

发起方
Frauenklinik der Universität zu Köln

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