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?
The study will include patients diagnosed with apical compartment genital prolapse of stage II or higher, who have an indication for surgical correction.
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.
Sequential
Vaginal mesh surgery for apical prolapse
Procedure/SurgeryCirurgia com tela vaginal para prolapso apical.
Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse
Procedure/SurgeryCirurgia robótica assistida por tela abdominal com dispositivo Upsylon (Boston Scientific - EUA) para prolapso apical vaginal.
Objective Cure Rate
The criteria for objective cure will be defined according to the Pelvic Organ Prolapse Quantification (POP-Q) system, with point C positioned at -6 cm or higher (proximal), corresponding to stage 0 or I genital prolapse.
Surgical complication
Complications will be evaluated in the perioperative period and during follow-up, encompassing surgical complications, long-term adverse events such as mesh erosion, and complications necessitating corrective interventions. These complications will be categorized according to the Clavien-Dindo classification system.
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