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
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
- 否
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)
