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

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ClinicalTrials.gov Identifier: NCT01347021
Recruitment Status : Unknown
Verified May 2006 by Federal University of São Paulo.
Recruitment status was:  Enrolling by invitation
First Posted : May 4, 2011
Last Update Posted : May 4, 2011
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment 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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2006
Primary Completion Date : December 2009
Estimated Study Completion Date : May 2011
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Pelvic Organ Prolapse Quantification (POPQ) at 12 months follow-up [ Time Frame: 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 :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: May 4, 2011    Key Record Dates
Last Update Posted: May 4, 2011
Last Verified: May 2006

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

Additional relevant MeSH terms:
Prolapse
Rupture
Pathological Conditions, Anatomical
Wounds and Injuries