跳至主要内容
临床试验/NCT04481906
NCT04481906已完成不适用

Long-term Follow-up of Vaginal Mesh Procedures for Female Cystocele

Cathay General Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2011年10月25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
160
试验地点
1
主要终点
POP-Q Ba point

研究概览

简要总结

This study aimed to evaluate primarily the functional outcomes and secondly the morphological outcomes for women who had received standard managements for cystocele at mediate-term follow-up.

详细描述

Pelvic organ prolapsed (POP) is an important health issue for women all over the world, with cystocele being the commonest type of POP. The side effects related to cystocele include voiding dysfunction, urinary retention, urinary tract infection, hydroureter, or hydronephrosis. The management for cystocele can be classified as non-surgical and surgical methods. Non-surgical methods comprise pelvic floor muscle exercise and vaginal pessaries, while surgical methods can be divided as conventional operations and operations applying mesh augmentation. Conventional surgeries for cystocele such as anterior colporrhapy have high surgical failure rates and complications including vaginal shortening or vaginal stenosis. Operations applying mesh augmentation are becoming the mainstream in the surgeries for cystocle. The Perigee System (American Medical Systems, Minnetonka, MN, USA), which has been approved by American FDA and Taiwan DOH in treating female cystocele, have promising short-term surgical outcomes. However, long-term reports incorporating both functional and morphological outcomes are lacking in the literatures. This study aimed to evaluate primarily the functional outcomes and secondly the morphological outcomes for women who had received standard managements for cystocele at mediate-term follow-up.

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
240 Months 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Clinical diagnosis of cystocele

排除标准

  • Pregnancy or possibility of future pregnancy
  • Urinary tract infection
  • Neurological diseases
  • Cardiovascular diseases

结局指标

主要结局

POP-Q Ba point

时间窗: Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly

POP-Q Ba \> II POP-Q stage

次要结局

  • Functional and ultrasound manifestations(Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验