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

NCT07359755 · University of Sao Paulo General Hospital · Updated 22 Jan 2026

What is being tested
Vaginal mesh surgery for apical prolapse; Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse
For
Pelvic Organ Prolapse (POP); Pelvic Organ Prolapse Vaginal Surgery; Mesh Reinforcement; Vaginal Apex/Uterine Prolapse
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 86 people. The full rules are on the registry page.
Where
Brazil
When
Starts or started 15 Sept 2025, ends June 2030. Registered 22 Jan 2026.
Results
None posted yet.

In the researchers' words

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?
ClinicalTrials.gov, NCT07359755

Sites

  • Hospital das Clinicas da Faculdade de Medicina de Sao PauloSão Paulo, São Paulo, Brazil