National, Multicentre Post-marketing Surveillance Study on Anterior Pelvic Prolapse Reconstruction With Titanium-coated Polypropylene Mesh (TiLOOP® Total 6)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 292
- 试验地点
- 9
- 主要终点
- Erosion rate
研究概览
简要总结
The purpose of this study is to determine the influence of Anterior Pelvic Prolapse Reconstruction with a titanised polypropylene mesh on rate of erosion and patients quality of live.
详细描述
This multicentre, non-randomised, observational clinical device investigation will be performed to obtain post-marketing information on the TiLOOP® pelvic floor reconstruction meshes and in particular on the rate of rare erosions of the device under investigation as well as on the improvement of patients' quality of life. It is expected that the rate of erosions is equal or lower compared to competitor devices currently on the market. To verify this, it will be shown that within the first year the erosion rate found for the product under investigation is in the range of 7.9 ± 5.4 %, which is the mean erosion rate found in the recent literature. Erosion, in the sense of the hypothesis, is any erosion 1 requiring more than simply the cut off of a single short filament.
It is also expected that the patient's quality of life is meliorated after implantation of a TiLOOP® Total 6 mesh. To verify this, it will be shown that by means of a validated questionnaire the subjective quality of life after 6 months is significantly better than before implantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Women with a symptomatic genital descensus : at least stage II (ICS-classification according POP-Q system), or stage I with a symptomatic requiring intervention. This applies to primary as well as recurrent intervention
- •Existence of a cystocele.
- •Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation
- •Patient information has been handed out and all written consents are at hand.
- •Patient has attained full age.
排除标准
- •Pregnancy or unfinished family planning.
- •Known intolerance to the mesh-implants under investigation.
- •Patients with acute (last 12 months) carcinoma.
- •Patients with history of radiotherapy in the pelvic area.
- •Genital descensus without any complaints.
- •Patients with implanted pelvic floor mesh.
- •Systemic steroid treatment.
- •Lack of written patients' informed consent.
- •Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol.
- •Patient is institutionalised by court or official order (MPG §20.3).
- •Participation in another clinical investigation.
结局指标
主要结局
Erosion rate
时间窗: 12 months
Erosion, in the sense of the end point, is any erosion requiring more than simply the cut off of a single short filament.
Patient's quality of life
时间窗: 6 months
It will be shown that by means of a validated questionnaire whether the subjective quality of life after 6 months is significantly better than before implantation.
次要结局
- Adverse Events(at 6, 12, 36 months)
- Feasibility of the mesh implantation(6 months)
- Erosion rate(36 months)
- Patient's quality of life(12 and 36 months)