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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 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-01-22

No results posted yet for this study

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?

Conditions

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

Interventions

PROCEDURE

Vaginal mesh surgery for apical prolapse

Cirurgia com tela vaginal para prolapso apical.

PROCEDURE

Robotic-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.

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2027-10-31
Completion
2030-06-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07359755 on ClinicalTrials.gov