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

University of Sao Paulo

Status and phase: Unknown; Phase 4

Conditions: Genital Prolapse

Treatments: Procedure: mesh repair; Procedure: fascial repair

Study type: Interventional

Funder types: Other

Identifiers

NCT00771225

300-07-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: Female

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Between 50 and 80 yrs

Exclusion criteria

• Less than 50 and more than 80 yrs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

prolapse surgery with fascial repair

Other group

Treatment:

Procedure: fascial repair

Procedure: mesh repair

prolapse surgery with mesh repair

Other group

Treatment:

Procedure: fascial repair

Procedure: mesh repair