RecruitingNot ApplicableNCT07359755

Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Prolapse - Prospective Randomized Non-inferiority Study

A Comparative Analysis of Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Genital Prolapse: a Prospective Randomized Non-inferiority Study.

Sponsor

University of Sao Paulo General Hospital

Enrollment

86 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

Pelvic organ prolapse (POP)Pelvic Organ Prolapse Vaginal Surgery Mesh Reinforcement Vaginal Apex/Uterine Prolapse

Summary

The goal of this study is to compare vaginal mesh surgery with abdominal robotic-assisted mesh surgery for the treatment of genital prolapse in women. The main questions it seeks to answer are: * Is the objective cure rate for vaginal mesh surgery non-inferior to that of the abdominal approach? * Is the use of vaginal mesh as safe as abdominal mesh?

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse and a procedure called Vaginal mesh surgery for apical prolapse for people with mesh reinforcement, pelvic organ prolapse vaginal surgery, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREVaginal mesh surgery for apical prolapse

Cirurgia com tela vaginal para prolapso apical.

PROCEDURERobotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse

Cirurgia robótica assistida por tela abdominal com dispositivo Upsylon (Boston Scientific - EUA) para prolapso apical vaginal.

Locations(1)

Hospital das Clinicas da Faculdade de Medicina de Sao Paulo

São Paulo, São Paulo, Brazil

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NCT07359755

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