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

Uterovaginal Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01347021
• Other study ID #: unifespcep0833/05
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: April 25, 2011
• Last updated: May 3, 2011
• Start date: May 2006
• Est. completion date: May 2011

Study information

• Verified date: May 2006
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 51
• Est. completion date: May 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Maher C, Feiner B, Baessler K, Adams EJ, Hagen S, 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. Review. Update in: Cochrane Database Syst Rev. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one year	No
Secondary	subjective improvement in quality of life measured by Quality-of-Life Questionnaire (P-QoL)after surgery at 12 months follow-up		one year	No

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