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
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- N81
- 发起方
- pfm medical gmbh
- 入组人数
- 175
- 状态
- 招募中
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
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.
结局指标
主要结局
未指定
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