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

A National Multicentric Randomised Study of the Correction of Genital Prolapse With Fascial Repair or Mesh (Prolift)

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00771225
Enrollment
180
Registered
2008-10-13
Start date
2008-11-30
Completion date
2013-11-30
Last updated
2010-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genital Prolapse

Keywords

genital prolapse, surgery, fascial repair, mesh, prolift

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.

Detailed description

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.

Interventions

PROCEDUREfascial repair

surgery to treat genital prolapse with fascia repair

PROCEDUREmesh repair

surgery to genital prolapse with mesh

Sponsors

University of Sao Paulo General Hospital
CollaboratorOTHER
Irmandade da Santa Casa de Misericordia de Sao Paulo
CollaboratorOTHER
Federal University of São Paulo
CollaboratorOTHER
Feculdade de Medicina da Universidade de Sao Paulo - Brasil
CollaboratorOTHER
University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Between 50 and 80 yrs

Exclusion criteria

* Less than 50 and more than 80 yrs

Design outcomes

Primary

MeasureTime frame
Correction of genital prolapse8 years

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026