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

Recruiting now · Not applicable

Conditions studied: Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery, Mesh Reinforcement, Vaginal Apex/Uterine Prolapse

In brief

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?

Key facts

Study ID

NCT07359755

Run by

University of Sao Paulo General Hospital

People needed

86

Starts

2025-09-15

Expected to finish

2030-06-01

Last updated by the study team

2026-01-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• The study will include patients diagnosed with apical compartment genital prolapse of stage II or higher, who have an indication for surgical correction.

You may not qualify if…

• The following exclusion criteria will apply: patients who are unable or unwilling to complete validated outcome assessment instruments; those requiring concomitant surgical procedures (e.g., hysterectomy or any other intervention that may alter pelvic floor anatomy);
• 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.

Where it is running

• Hospital das Clinicas da Faculdade de Medicina de Sao Paulo — São Paulo, São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.