Compare Sacrospinous Fixation Versus High Uterosacral Ligament Fixation for Uterus Vaginal Prolapse III/IV

Uterovaginal Prolapse Clinical Trial

Official title: Sacrospinous Colpopexy Versus High Uterosacral Colpopexy in the Treatment of Genital Prolapse Grade III/IV in Women With Uterus

Status Enrolling by invitation

Clinical Trial Summary

The purpose of this study is to compare the vaginal sacrospinous colpopexy and high uterosacral colpopexy in the treatment of genital prolapse grade III/IV in women with uterus.

Clinical Trial Description

Hysterectomy is often the traditional approach for women with uterovaginal prolapse. However, hysterectomy alone does not address the underlying problem of deficient apical support. Surgical options for patients with apical prolapse include transvaginal suspension procedures using pelvic structures for fixation, such as the sacrospinous ligament or uterosacral ligaments.The objective of this study is to compare the sacrospinous fixation with high uterosacral in the treatment of uterine prolapse POP-Q stage 3 or 4 in terms of recurrence of prolapse,quality of life,complications,post-operative recovery, hospital stay. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complete Tear, Sacrospinous Ligament
• Prolapse
• Prolapse of Vaginal Vault After Hysterectomy
• Uterosacral Ligament; Rupture
• Uterovaginal Prolapse

• NCT number: NCT01347021
• Study type: Interventional
• Source: Federal University of São Paulo
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: May 2006
• Completion date: May 2011