NCT01347021

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2011

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2011

Completed
Last Updated

May 4, 2011

Status Verified

May 1, 2006

Enrollment Period

3.6 years

First QC Date

April 25, 2011

Last Update Submit

May 3, 2011

Conditions

Uterovaginal ProlapseProlapse of Vaginal Vault After HysterectomyComplete Tear, Sacrospinous LigamentUterosacral Ligament; Rupture

Keywords

vaginal colpopexy sacrospinousvaginal colpopexy uterosacral

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

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

    one year

Study Arms (2)

sacrospinous, pelvic prolapse.

ACTIVE COMPARATOR

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

uterosacral , pelvic prolapse.

ACTIVE COMPARATOR

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

Interventions

sacrospinous colpopexy versus high uterosacral colpopexyPROCEDURE

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.

Also known as: Sacrospinous ligament fixation(SLF), McCall culdoplasty
sacrospinous, pelvic prolapse.uterosacral , pelvic prolapse.

Eligibility Criteria

Age50 Years - 85 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pelvic prolapse III/IV
  • counselling and informed consent

You may not qualify if:

  • abnormal cervical smears
  • abnormal ultrasound findings of uterus or ovaries or abnormal uterine bleeding
  • pelvic radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, 04023062, Brazil

Location

Related Publications (2)

  • Maher C, Feiner B, Baessler K, 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.

    PMID: 20393938RESULT

  • Martins SB, Castro RA, Takano CC, Marquini GV, Oliveira LM, Martins Junior PCF, Dias MM, Girao MJBC, Sartori MGF. Efficacy of Sacrospinous Fixation or Uterosacral Ligament Suspension for Pelvic Organ Prolapse in Stages III and IV: Randomized Clinical Trial. Rev Bras Ginecol Obstet. 2023 Oct;45(10):e584-e593. doi: 10.1055/s-0043-1772592. Epub 2023 Nov 9.

    PMID: 37944925DERIVED

Related Links

MeSH Terms

Conditions

Rupture

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Manoel C B Girão, MD

    Federal University of São Paulo

    STUDY CHAIR

  • Sergio B Martins, md

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 25, 2011

First Posted

May 4, 2011

Study Start

May 1, 2006

Primary Completion

December 1, 2009

Study Completion

May 1, 2011

Last Updated

May 4, 2011

Record last verified: 2006-05

Locations

BR(1)