Vaginal versus robotic-assisted abdominal mesh repair for apical prolapse

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.

This study will test whether vaginal mesh repair works as well and is as safe as robotic-assisted abdominal mesh repair for women with stage II or higher apical pelvic organ prolapse.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 86 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University of Sao Paulo General Hospital (Academic / other)
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT07359755 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized non-inferiority trial comparing objective outcomes after vaginal mesh repair versus robot-assisted abdominal mesh repair for apical compartment pelvic organ prolapse. Eligible women with stage II or higher apical prolapse are randomized via REDCap to receive either Splentis® vaginal mesh with bilateral sacrospinous anchoring or Upsylon® mesh via robot-assisted colpocervicopexy to the sacral promontory. Primary outcome is objective cure (stage 0 or I) and secondary outcomes include mesh erosion, pain, and symptom-specific quality of life measured with a Portuguese-validated instrument. The sample size is calculated to test non-inferiority based on assumed cure rates for the two approaches.

Who should consider this trial

Good fit: Women with apical compartment pelvic organ prolapse stage II or higher who are candidates for elective operative correction and can complete Portuguese-language outcome questionnaires are ideal candidates.

Not a fit: Patients who need concomitant procedures that alter pelvic anatomy, have prior pelvic radiotherapy, congenital or acquired urogenital/gastrointestinal anomalies, or other contraindications to elective surgery are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, vaginal mesh repair could provide a similarly effective and safe alternative to robotic abdominal repair, potentially offering a less invasive option with shorter recovery and lower resource use.

How similar studies have performed: Robotic sacrocolpopexy has demonstrated high success rates in prior studies while outcomes and safety of transvaginal mesh have been more mixed, so randomized direct comparisons like this are relatively uncommon.

Eligibility criteria

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.

Where this trial is running

São Paulo, São Paulo

• Hospital das Clinicas da Faculdade de Medicina de Sao Paulo — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Study coordinator: Marcelo Hisano, MD PhD

Conditions Pelvic Organ Prolapse; Pelvic Organ Prolapse Vaginal Surgery; Mesh Reinforcement; Vaginal Apex/Uterine Prolapse; Pelvic organ prolapse; Vaginal prolapse; Vaginal mesh; Robotic-assisted sacrocolpopexy