NCT00196495已完成4 期
Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Effectiveness of the TVM treatment in curing vaginal prolapse as indicated by recurrence rate.
研究概览
简要总结
Pelvic floor prolapse is a general term used to describe various clinical conditions that are associated with pelvic floor (muscles that support the vagina) relaxation in female patients.Pelvic floor prolapse is thought to result from a stretching, weakening or tearing of the soft tissue structures that support the pelvic organs. These tissues become compromised because of a weakened or damaged.The purpose of the study will be to demonstrate the usability of Polypropylene Mesh for prolapse repair, using the TVM technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Female candidate for surgical pelvic floor repair (at least ICS stage II symptomatic prolapse).
- •Patient who is at leat 21 years of age.
- •Patient whose family is complete.
- •Patient may not have uncontrolled diabetes.
排除标准
- •Patients may not have coagulation disorders.
结局指标
主要结局
Effectiveness of the TVM treatment in curing vaginal prolapse as indicated by recurrence rate.
次要结局
- Intraoperative complication
- Patient tolerance of the synthetic mesh placed
- Postoperative complications
- Quality of life
研究者
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