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

Primary Purpose

Uterovaginal Prolapse, Prolapse of Vaginal Vault After Hysterectomy, Complete Tear, Sacrospinous Ligament

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
sacrospinous colpopexy versus high uterosacral colpopexy
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterovaginal Prolapse focused on measuring vaginal colpopexy sacrospinous, vaginal colpopexy uterosacral

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Federal University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

sacrospinous, pelvic prolapse.

uterosacral , pelvic prolapse.

Arm Description

Women with pelvic prolapse grade III/IV were randomly allocated to the sacrospinous colpopexy (25 women) or high uterosacral (26 women)

Women with pelvic prolapse grade III/IV were randomly allocated to the sacrospinous colpopexy (25 women) or high uterosacral (26 women)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 25, 2011
Last Updated
May 3, 2011
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01347021
Brief Title
Compare Sacrospinous Fixation Versus High Uterosacral Ligament Fixation for Uterus Vaginal Prolapse III/IV
Official Title
Sacrospinous Colpopexy Versus High Uterosacral Colpopexy in the Treatment of Genital Prolapse Grade III/IV in Women With Uterus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Unknown status
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
May 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterovaginal Prolapse, Prolapse of Vaginal Vault After Hysterectomy, Complete Tear, Sacrospinous Ligament, Uterosacral Ligament; Rupture
Keywords
vaginal colpopexy sacrospinous, vaginal colpopexy uterosacral

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sacrospinous, pelvic prolapse.
Arm Type
Active Comparator
Arm Description
Women with pelvic prolapse grade III/IV were randomly allocated to the sacrospinous colpopexy (25 women) or high uterosacral (26 women)
Arm Title
uterosacral , pelvic prolapse.
Arm Type
Active Comparator
Arm Description
Women with pelvic prolapse grade III/IV were randomly allocated to the sacrospinous colpopexy (25 women) or high uterosacral (26 women)
Intervention Type
Procedure
Intervention Name(s)
sacrospinous colpopexy versus high uterosacral colpopexy
Other Intervention Name(s)
Sacrospinous ligament fixation(SLF), McCall culdoplasty
Intervention Description
Women with uterine prolapse grade III or IV were randomly allocated to the sacrospinous colpopexy or high uterosacral colpopexy with vaginal hysterectomy.Before the surgery P-Qol questionnaire were completed and urogynecological examination include de POP-Q system was done. All patients underwent clinical check-ups 1, 6 and 12 months postoperatively. Each check-up included clinical examination and questionnaire.
Primary Outcome Measure Information:
Title
Pelvic Organ Prolapse Quantification (POPQ) at 12 months follow-up
Description
Quantification of pelvic organ prolapse, according to the Pelvic Organ Prolapse Quantification system (POPQ), as standardized by the International Continence Society.
Time Frame
one year
Secondary Outcome Measure Information:
Title
subjective improvement in quality of life measured by Quality-of-Life Questionnaire (P-QoL)after surgery at 12 months follow-up
Time Frame
one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manoel C B Girão, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sergio B Martins, md
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of São Paulo
City
São Paulo
ZIP/Postal Code
04023062
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
20393938
Citation
Maher C, Feiner B, Baessler K, Glazener CM. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2010 Apr 14;(4):CD004014. doi: 10.1002/14651858.CD004014.pub4.
Results Reference
result
Links:
URL
http://iuga.org
Description
clik here for more information about this issue - international urogynecology journal

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

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