Mesh Reinforcement, Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery, Vaginal Apex/Uterine Prolapse
Conditions
Keywords
Pelvic organ prolapse, Vaginal prolapse, Vaginal mesh, Robotic-assisted sacrocolpopexy, Sacrocolpopexy, Uterine prolapse
Brief 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?
Detailed 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.
Interventions
PROCEDUREVaginal mesh surgery for apical prolapse
Cirurgia com tela vaginal para prolapso apical.
PROCEDURERobotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse
Cirurgia robótica assistida por tela abdominal com dispositivo Upsylon (Boston Scientific - EUA) para prolapso apical vaginal.
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This prospective, randomized trial is designed to evaluate the treatment of apical vaginal prolapse, with the objective of demonstrating the non-inferiority of vaginal mesh repair compared to robotic-assisted abdominal sacral colpopexy. The assessment will focus on objective cure rates as well as secondary outcomes, including clinical complications, mesh erosion, and patient-reported clinical improvements measured through validated questionnaires.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Cure Rate | Patients will undergo evaluations at 1 month postoperatively and subsequently at 6-month intervals from the date of surgery, continuing until 24 months of follow-up have been completed. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical complication | Patients will undergo evaluations at 1 month postoperatively and subsequently at 6-month intervals from the date of surgery, continuing until 24 months of follow-up have been completed. | 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. |
Countries
Brazil
Contacts
CONTACTMarcelo Hisano, MD PhD
Outcome results
None listed