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?
Eligibility criteria
Qualifiers
The study will include patients diagnosed with apical compartment genital prolapse of stage II or higher, who have an indication for surgical correction.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Vaginal mesh surgery for apical prolapse
- Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse