A Comparative Analysis of Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Genital Prolapse: a Prospective Randomized Non-inferiority Study.
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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?
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• The study will include patients diagnosed with apical compartment genital prolapse of stage II or higher, who have an indication for surgical correction.
Locations
Other Locations
Brazil
Hospital das Clinicas da Faculdade de Medicina de Sao Paulo
RECRUITING
São Paulo
Contact Information
Primary
Marcelo Hisano, MD PhD
m.hisano@hc.fm.usp.br
551126618080
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2030-06
Participants
Target number of participants: 86
Treatments
Experimental: Vaginal mesh surgery
Vaginal mesh surgery for apical prolapse
Active_comparator: Robotic-assited abdominal sacrocolpopexy
Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse
Related Therapeutic Areas
Sponsors
Leads: University of Sao Paulo General Hospital