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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01347021
First received: April 25, 2011
Last updated: May 3, 2011
Last verified: May 2006
  Purpose

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.


Condition Intervention Phase
Uterovaginal Prolapse
Prolapse of Vaginal Vault After Hysterectomy
Complete Tear, Sacrospinous Ligament
Uterosacral Ligament; Rupture
Procedure: sacrospinous colpopexy versus high uterosacral colpopexy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sacrospinous Colpopexy Versus High Uterosacral Colpopexy in the Treatment of Genital Prolapse Grade III/IV in Women With Uterus

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Pelvic Organ Prolapse Quantification (POPQ) at 12 months follow-up [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: May 2006
Estimated Study Completion Date: May 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: sacrospinous, pelvic prolapse.
Women with pelvic prolapse grade III/IV were randomly allocated to the sacrospinous colpopexy (25 women) or high uterosacral (26 women)
Procedure: sacrospinous colpopexy versus high uterosacral colpopexy
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.
Other Names:
  • Sacrospinous ligament fixation(SLF)
  • McCall culdoplasty
Active Comparator: uterosacral , pelvic prolapse.
Women with pelvic prolapse grade III/IV were randomly allocated to the sacrospinous colpopexy (25 women) or high uterosacral (26 women)
Procedure: sacrospinous colpopexy versus high uterosacral colpopexy
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.
Other Names:
  • Sacrospinous ligament fixation(SLF)
  • McCall culdoplasty

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347021

Locations
Brazil
Federal University of São Paulo
São Paulo, Brazil, 04023062
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Chair: Manoel C B Girão, MD Federal University of São Paulo
Principal Investigator: Sergio B Martins, md Federal University of São Paulo
  More Information

Additional Information:
Publications:
Responsible Party: sergio brasileiro martins md, unifesp- gynecology session
ClinicalTrials.gov Identifier: NCT01347021     History of Changes
Other Study ID Numbers: unifespcep0833/05
Study First Received: April 25, 2011
Last Updated: May 3, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
vaginal colpopexy sacrospinous
vaginal colpopexy uterosacral

Additional relevant MeSH terms:
Prolapse
Uterine Prolapse
Rupture
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female
Pelvic Organ Prolapse
Wounds and Injuries

ClinicalTrials.gov processed this record on August 21, 2014