NCT00771225

Brief Summary

180 women with genital prolapse will be submitted to genital prolapse surgical correction, half of them with human fascia, and the other half with Prolift.

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
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2008

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

First Submitted

Initial submission to the registry

October 10, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2008

Completed
19 days until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

February 3, 2010

Status Verified

October 1, 2008

Enrollment Period

4 years

First QC Date

October 10, 2008

Last Update Submit

February 2, 2010

Conditions

Genital Prolapse

Keywords

genital prolapsesurgeryfascial repairmeshprolift

Outcome Measures

Primary Outcomes (1)

  • Correction of genital prolapse

    8 years

Study Arms (2)

prolapse surgery with fascial repair

OTHER
Procedure: fascial repairProcedure: mesh repair

prolapse surgery with mesh repair

OTHER
Procedure: fascial repairProcedure: mesh repair

Interventions

fascial repairPROCEDURE

surgery to treat genital prolapse with fascia repair

Also known as: prolapse repair withouth mesh, prolapse repair with mesh, prolift
prolapse surgery with fascial repairprolapse surgery with mesh repair
mesh repairPROCEDURE

surgery to genital prolapse with mesh

Also known as: prolapse repair withouth mesh, prolapse repair with mesh, prolift
prolapse surgery with fascial repairprolapse surgery with mesh repair

Eligibility Criteria

Age50 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 50 and 80 yrs

You may not qualify if:

  • Less than 50 and more than 80 yrs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Simone Brandao

São Paulo, São Paulo, 05508-000, Brazil

Location

MeSH Terms

Interventions

Melanocyte-Stimulating Hormones

Intervention Hierarchy (Ancestors)

MelanocortinsPro-OpiomelanocortinHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Simone Brandao

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 10, 2008

First Posted

October 13, 2008

Study Start

November 1, 2008

Primary Completion

November 1, 2012

Study Completion

November 1, 2013

Last Updated

February 3, 2010

Record last verified: 2008-10

Locations

BR(1)