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

RecruitingNAAges 18 Years - anyFemaleUniversity of Sao Paulo General Hospital
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In plain words

What the trial is, and whether it could suit you

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?

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Vaginal mesh surgery for apical prolapse
  • Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse
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Where

1 site
Hospital das Clinicas da Faculdade de Medicina de Sao Paulo
Sรฃo Paulo, Brazil
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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