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

University of Sao Paulo General Hospital

Status

Enrolling

Conditions

Pelvic Organ Prolapse (POP)

Vaginal Apex/Uterine Prolapse

Pelvic Organ Prolapse Vaginal Surgery

Mesh Reinforcement

Treatments

Procedure: Vaginal mesh surgery for apical prolapse

Procedure: Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse

Study type

Interventional

Funder types

Other

Identifiers

NCT07359755

7.815.545

86242424.1.0000.0068 (Registry Identifier)

Details and patient eligibility

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?

Full description

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.

Enrollment

86 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.