National, 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)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 175
- 试验地点
- 7
- 主要终点
- Patient´s Quality of Life
研究概览
简要总结
National, multicentre observational study on surgical reconstruction of the anterior and apical compartment of the pelvic floor with an SRS implant
详细描述
National, multicentre, prospective observational study on surgical reconstruction of the anterior and apical compartment in seven clinical centres in Germany to obtain post-market information on the SRS implant with a follow-up of 24 months. Patient reported satisfaction (measured by P QoL, Prolapse Quality of Life Questionnaire), anatomic outcome (measured by the POP-Q, Pelvic Organ Prolapse Quantification system) and the rate of complications (measured by adverse events during the study period) are focused.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
- •Age ≥ 21 years.
- •Patient is mentally able to understand the nature, aims, or possible consequences of the PMCF study.
- •Patient information has been provided and written consent exists.
排除标准
- •Contraindications according to the manufacturer's instructions for use.
- •Patient with previous urogynaecological surgeries with alloplastic material.
- •Patient with radiological treatment in the pelvic floor.
- •Patient is institutionalised by court or official order (MPDG §27).
- •Participation in another interventional study concerning pelvic floor reconstruction.
结局指标
主要结局
Patient´s Quality of Life
时间窗: 12 months
Evaluation of changes in quality of life twelve months after implantation of the SRS implant compared to baseline. Quality of Life was assessed by the P-QOL (Prolapse Quality of Life Questionnaire). The P-QOL yields a domain score in the range from zero to 100, wheras a score of zero is the best.
次要结局
未报告次要终点