National,Multicentric Randomised Study of the Correction of Genital Prolapse With Fascial Repair or Mesh-Prolift

NCT ID: NCT00771225

Last Updated: 2010-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.Are eligible women aged between 50 and 80 years old.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Genital Prolapse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

prolapse surgery with fascial repair

Group Type OTHER

fascial repair

Intervention Type PROCEDURE

surgery to treat genital prolapse with fascia repair

mesh repair

Intervention Type PROCEDURE

surgery to genital prolapse with mesh

prolapse surgery with mesh repair

Group Type OTHER

fascial repair

Intervention Type PROCEDURE

surgery to treat genital prolapse with fascia repair

mesh repair

Intervention Type PROCEDURE

surgery to genital prolapse with mesh

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fascial repair

surgery to treat genital prolapse with fascia repair

Intervention Type PROCEDURE

mesh repair

surgery to genital prolapse with mesh

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

prolapse repair withouth mesh prolapse repair with mesh prolift prolapse repair withouth mesh prolapse repair with mesh prolift

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Between 50 and 80 yrs

Exclusion Criteria

* Less than 50 and more than 80 yrs
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Sao Paulo General Hospital

OTHER

Sponsor Role collaborator

Irmandade da Santa Casa de Misericordia de Sao Paulo

OTHER

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role collaborator

Feculdade de Medicina da Universidade de Sao Paulo - Brasil

OTHER

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hospital Universitario da Universidade de Sao Paulo

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Simone Brandao

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Simone Brandao

São Paulo, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

300-07-002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.