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.
University of Sao Paulo General Hospital
86 participants
Sep 15, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria1
- The study will include patients diagnosed with apical compartment genital prolapse of stage II or higher, who have an indication for surgical correction.
Exclusion Criteria3
- individuals with a prior history of pelvic radiotherapy;
- patients with congenital or acquired anomalies of the urogenital or gastrointestinal systems;
- and those with medical conditions that constitute a contraindication to elective surgical intervention.
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Interventions
Cirurgia com tela vaginal para prolapso apical.
Cirurgia robótica assistida por tela abdominal com dispositivo Upsylon (Boston Scientific - EUA) para prolapso apical vaginal.
Locations(1)
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NCT07359755