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Clinical Trials/NCT01347021
NCT01347021
Unknown
Phase 4

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

Federal University of São Paulo1 site in 1 country51 target enrollmentMay 2006

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Uterovaginal Prolapse
Sponsor
Federal University of São Paulo
Enrollment
51
Locations
1
Primary Endpoint
Pelvic Organ Prolapse Quantification (POPQ) at 12 months follow-up
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2006
End Date
May 2011
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Federal University of São Paulo

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

Outcomes

Primary Outcomes

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 Outcomes

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

Study Sites (1)

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