Vaginal versus robotic-assisted abdominal mesh repair for apical prolapse

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Marcelo Hisano, MD PhD
• Email: m.hisano@hc.fm.usp.br
• Phone: 551126618080

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.