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

Federal University of São Paulo

Status and phase: Unknown; Phase 4

Conditions: Prolapse of Vaginal Vault After Hysterectomy; Uterosacral Ligament; Rupture; Uterovaginal Prolapse; Complete Tear, Sacrospinous Ligament

Treatments: Procedure: sacrospinous colpopexy versus high uterosacral colpopexy

Study type: Interventional

Funder types: Other

Identifiers

NCT01347021

unifespcep0833/05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: Female

Ages: 50 to 85 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 2 patient groups

sacrospinous, pelvic prolapse.

Active Comparator group

Description:

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

Treatment:

Procedure: sacrospinous colpopexy versus high uterosacral colpopexy

uterosacral , pelvic prolapse.

Active Comparator group

Description:

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

Treatment:

Procedure: sacrospinous colpopexy versus high uterosacral colpopexy