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临床试验/NCT02536001
NCT02536001Unknown不适用

Prospective Randomized Study to Compare Anatomical, Functional and Sexual Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes While Preserving the Uterus

Ziv Hospital0 个研究点目标入组 100 人开始时间: 2015年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
Complications rate

研究概览

简要总结

The purpose of this study is to compare anatomical differences, quality of life and sexual function and complications rate between apical support with one anterior vaginal mesh versus repair with two separate meshes.

详细描述

In the presence of stage 3 anterior wall prolapse (cystocele) with second stage apical prolapse (uterine or vault prolapse) there are 2 optional ways to repair with vaginal mesh: (a) to use 2 separated meshes: anterior mesh to correct the anterior compartment and posterior mesh to correct the apical prolapse to the sacrospinous ligament (SSL). (b) To correct both anterior compartment and the apical prolapse with the same mesh while using the posterior arms of the mesh to fix the apical prolapse to the SSL. Each way has its advantages and disadvantages. The first way was described at the beginning of mesh use and might be more anatomical then the second newest way. The addition of apical support to the anterior mesh might theoretically shorten the vagina. There are several recent studies describing the anatomical outcomes both for anterior compartment and apical compartment with a single mesh. Mesh-related complications, which can be also related to the amount of vaginal meshes, can potentially decrease with one mesh as compare with 2 meshes.

The aim of the study:

If the anatomical results, vaginal length and quality of life, will be with no significant differences between the two groups, the investigators will recommend to use a single mesh, in order to avoid / minimize potential complications of vaginal mesh.

If there will be no differences in complications in both groups but will be a significant difference in vaginal length and sexual function, the investigators will recommend using two meshes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • At least anterior compartment prolapse stage III and uterine prolapse stage II.

排除标准

  • Women without uterine prolapse, or with uterine prolapse < stage
  • Women with uterine prolapse > stage
  • Hysterectomy in the past.
  • Women with an indication for hysterectomy.

结局指标

主要结局

Complications rate

时间窗: 2 years

comparing complications rate between groups

Sexual function

时间窗: 2 years

use validated questionnaires before and after surgery

Vaginal length between the arms

时间窗: 2 years

measure total vaginal length after surgery

Quality of life

时间窗: 2 years

use validated questionnaires before and after surgery

次要结局

  • To examine anatomical results(2 years)
  • Success rate of uterus preservation(2 years)

研究者

发起方
Ziv Hospital
申办方类型
Other Gov
责任方
Sponsor

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