Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Prolapse - Prospective Randomized Non-inferiority Study
Recruiting
N/A
Interventional Study
Pelvic Organ Prolapse (POP)
Pelvic Organ Prolapse Vaginal Surgery
Mesh Reinforcement
Vaginal Apex/Uterine Prolapse
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 86 (estimated)
- Sponsor
- University of Sao Paulo General Hospital · Other
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About This Trial
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?
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* The study will include patients diagnosed with apical compartment genital prolapse of stage II or higher, who have an indication for surgical correction.
Exclusion Criteria:
* The following exclusion criteria will apply: patients who are unable or unwilling to complete valid…
Contacts