Actively Recruiting
Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Prolapse - Prospective Randomized Non-inferiority Study
Led by University of Sao Paulo General Hospital · Updated on 2026-01-22
86
Participants Needed
1
Research Sites
245 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Prolapse - Prospective Randomized Non-inferiority Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with stage II or higher apical compartment genital prolapse
- Patients with a medical indication for surgical correction
- Patients willing and able to provide informed consent and complete outcome assessments
You will not qualify if you...
- Patients unable or unwilling to complete validated outcome assessment instruments
- Patients requiring additional surgical procedures that may change pelvic floor anatomy (e.g., hysterectomy)
- Patients with prior pelvic radiotherapy
- Patients with congenital or acquired anomalies of the urogenital or gastrointestinal systems
- Patients with medical conditions contraindicating elective surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital das Clinicas da Faculdade de Medicina de Sao Paulo
São Paulo, São Paulo, Brazil, 05403000
Actively Recruiting
Research Team
M
Marcelo Hisano, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here