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临床试验/NCT03764891
NCT03764891已完成不适用

Far Eastern Memorial Hospital

Far Eastern Memorial Hospital1 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2018年11月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
152
试验地点
1
主要终点
Recurrence rate of pelvic organ prolapse

研究概览

简要总结

Pelvic organ prolapse (POP) is a major health concern, affecting more than 30% of women.

The aim of this study was to compare the clinical outcomes of Uphold system and Perigee system in treating women with cystocele.

详细描述

Pelvic organ prolapse (POP) is a major health concern, affecting more than 30% of women. Traditional vaginal surgery with native tissue is associated with high recurrence rate. Thus, synthetic meshes were introduced into POP surgery and became the mainstream. Several transvaginal mesh procedures, such as Uphold system (Boston Scientific) and Perigee system (American Medical Systems Inc), have been used for cystocele repair. Perigee system is a trans-obturator four-arm mesh device attached to proximal and distal arcus tendineus fasciae pelvis. Nonetheless, Uphold system, is a single incised, two-arm anterior sacrospinous mesh fixation system. Both systems can be used for cystocele repair, despite Uphold system can be used for concomitant repair of apical prolapse. The aim of this study was to compare the clinical outcomes of Uphold system and Perigee system in treating women with cystocele.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Vaginal anterior wall prolapse greater than or equal to second phase of POP-Q
  • Underwent Uphold or Perigee procedures

排除标准

  • 未提供

结局指标

主要结局

Recurrence rate of pelvic organ prolapse

时间窗: 10 year

Compare the recurrence rate of Uphold system and Perigee system in treating women with cystocele.

次要结局

  • Complication rate(10 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sheng-Mou Hsiao

Chief, Department of Obstetrics & Gynecology

Far Eastern Memorial Hospital

研究点 (1)

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