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

Phase 4

• Conditions: Uterovaginal Prolapse; Prolapse of Vaginal Vault After Hysterectomy; Complete Tear, Sacrospinous Ligament; Uterosacral Ligament; Rupture
• Interventions: Procedure: sacrospinous colpopexy versus high uterosacral colpopexy

• Registration Number: NCT01347021
• Lead Sponsor: Federal University of São Paulo

Brief 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.

Detailed 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 Timeline

• Status Verified: 2006-05
• Study Start: 2006-05
• Primary Completion: 2009-12
• Study First Submitted: 2011-04-25
• Study Completion: 2011-05
• Study First Submitted QC: 2011-05-03
• Last Update Submitted: 2011-05-03
• Study First Posted: 2011-05-04
• Last Update Posted: 2011-05-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 51

Inclusion Criteria

• pelvic prolapse III/IV
• counselling and informed consent

Exclusion Criteria

• abnormal cervical smears
• abnormal ultrasound findings of uterus or ovaries or abnormal uterine bleeding
• pelvic radiotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sacrospinous, pelvic prolapse.	sacrospinous colpopexy versus high uterosacral colpopexy	Women with pelvic prolapse grade III/IV were randomly allocated to the sacrospinous colpopexy (25 women) or high uterosacral (26 women)
uterosacral , pelvic prolapse.	sacrospinous colpopexy versus high uterosacral colpopexy	Women with pelvic prolapse grade III/IV were randomly allocated to the sacrospinous colpopexy (25 women) or high uterosacral (26 women)

Primary Outcome Measures

Name	Time	Method
Pelvic Organ Prolapse Quantification (POPQ) at 12 months follow-up	one year	Quantification of pelvic organ prolapse, according to the Pelvic Organ Prolapse Quantification system (POPQ), as standardized by the International Continence Society.

Secondary Outcome Measures

Name	Time	Method
subjective improvement in quality of life measured by Quality-of-Life Questionnaire (P-QoL)after surgery at 12 months follow-up	one year

Trial Locations

Locations (1)

Federal University of São Paulo; 🇧🇷 São Paulo, Brazil