DRKS00025856招募中不适用
ational, multicentre observational study on surgical reconstruction of the anterior and apical compartment of the pelvic floor with a single incision, fixation free Self-Retaining Support implant (SRS implant) - PMCF study SRS implant
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 175
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
- 21 Years 至 one（—）
- 性别
- Female
入选标准
- •1) Women with a symptomatic anterior vaginal wall prolapse with/without apex/uterine prolapse = stage II (according to POP-Q system). This applies to primary as well as recurrent intervention. 2) Age = 21 years.
- •3) Patient is mentally able to understand the nature, aims, or possible consequences of the PMCF study.
- •4) Patient information has been provided and written consent exists.
排除标准
- •1) Contraindications according to the manufacturer’s instructions for use.
- •2) 2)Patient with previous urogynaecological surgeries with alloplastic material.
- •3) Patient with radiological treatment in the pelvic floor.
- •4) Patient is institutionalised by court or official order (MPDG §27).
- •5) Participation in another interventional study concerning pelvic floor reconstruction.
研究者
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