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临床试验/DRKS00011657
DRKS00011657已完成不适用

Prospective multicenter post- marketing surveillance study for surgical pelvic floor reconstruction in the anterior compartment with the polypropylen mesh InGYNious - InGYNious - AWB

A.M.I. GmbH (Agency for Medical Innovations)0 个研究点目标入组 254 人开始时间: 2017年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
254

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

  • symptomatic cystocele according to ICS (international continence society) grade >= POPQ 2 (primary cystocele and recurrence)
  • Compliance according to evaluation of data, therapy and follow- up
  • Written consent form of patient

排除标准

  • Asymptomatic prolapse of uterus
  • age< 18 years
  • missing written consent form
  • lacling compliance according to evaluation of data, therapy and follow- up
  • known incompatibility in regard to mesh products
  • expectation of life less than period of review, ASA 4
  • progredient malignancy
  • state after radiotherapy of the true pelvis
  • chronic cortisone medication
  • fibromyalgia, chronic pain syndrome, connective tissue disease, immunodeficiency

研究者

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