Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Prolapse - Prospective Randomized Non-inferiority Study

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.

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?

This is a prospective, randomized non-inferiority study designed to compare the objective outcomes of treating apical compartment pelvic organ prolapse (POP) using robot-assisted abdominal mesh surgery versus vaginal mesh surgery. Additionally, clinical parameters such as mesh erosion, pain, and symptom-specific quality of life will be assessed utilizing an internationally validated instrument adapted for Portuguese-speaking populations.

Patients diagnosed with stage II or higher apical compartment pelvic organ prolapse (POP), with or without a uterus, who require surgical intervention and provide informed consent will be randomized through REDCap® software to determine the surgical approach.

The interventions under investigation include: vaginal prolapse repair with placement of the Splentis® mesh (Promedon®, Córdoba, Argentina) - not FDA approved, comprising anterior colporrhaphy combined with suspension of the cervix or vaginal vault, with bilateral anchoring of the mesh to the sacrospinous ligaments; and robot-assisted laparoscopic abdominal repair employing the Upsylon® mesh (Boston Scientific®, USA) - FDA approved - via colpocervicopexy, involving mesh fixation to the anterior and superior vaginal walls as well as the sacral promontory.

The sample size was calculated to assess the non-inferiority of the vaginal approach compared with the abdominal approach. Assuming an objective cure rate (stage 0 or I) of 90% for the abdominal group and 80% for the vaginal group, with a two-sided significance level of p < 0.05 and an anticipated loss to follow-up of up to 10% in each group, a minimum of 43 participants per arm (total of 86 patients) was required. The calculation was based on detecting a non-inferiority margin considered clinically acceptable for the primary outcome.

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 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.