Retrospective Data Analysis PelviGYNious/EndoGYNious (PMCF-4.2-004)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Patient subjective outcome
研究概览
简要总结
The retrospective patient chart review aims to generate additional data to substantiate the safety and performance of EndoGYNious and PelviGYNious.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Surgery for POP
- •Implantation of either EndoGYNious or PelviGYNious
- •Concomitant procedures are allowed
- •Women minimum 18 years old
- •Written informed consent for surgery
排除标准
- •Patients who rule out subsequent contact by the hospital will be excluded.
- •The use of the products is contraindicated in case of:
- •pregnancy and/or patients who consider future pregnancies
- •adolescent/ pubescent patients
- •existence of a known sensitivity/ allergy against plastic materials such as polypropylene, polyester, etc.
- •any pathology, including known or suspected uterine pathology, which would compromise placement of the implant/mesh (e.g. anatomical distortion or abnormalities)
- •known anticoagulation disorder
- •anticoagulant therapy
- •autoimmune connective tissue disease
- •renal insufficiency and upper urinary tract obstruction
- •cancer illnesses of the vagina / cervix / rectum
- •undergone radiation therapy on the vagina, cervix, rectum
- •planned or emergency opening of the gastro-intestinal tract, as this could cause a risk of product contamination that could lead to infection that would require removal of the implant/device
- •active or latent infection especially of the genital system and/or urinary tract
结局指标
主要结局
Patient subjective outcome
时间窗: From baseline to the end of last follow-up [3 months, 12 months]
Patient subjective outcome after POP treatment with EndoGYNious or PelviGYNious will be measured with a validated questionnaire (German Pelvic Floor Questionnaire "Deutscher Beckenboden-Fragebogen") . This questionnaire focus on 4 items (bladder, bowel, prolapse, sexuality). Each item has its scores, scores were summed up for each category (bladder max. 45, bowel max. 34, prolapse max. 15, sexual max. 21), Calculation: (achieved value of category/ max. value of category)\*10; max. value 10 for each category, max. final score 40 The postoperative scores will be compared with the preoperative scores.
次要结局
- Postoperative complications(From baseline to the end of last follow-up [average of minimum 3 months])
- Anatomical success (POP-Q)(From baseline to the end of last follow-up [average of minimum 3 months])