RecruitingNot Applicable

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

Brazil86 participantsStarted 2025-09-15

Plain-language 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?

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Objective Cure Rate

Timeframe: 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.

Trial details

NCT IDNCT07359755

SponsorUniversity of Sao Paulo General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10

Contact for this trial

Marcelo Hisano, MD PhD

551126618080 m.hisano@hc.fm.usp.br

View on ClinicalTrials.gov More Pelvic Organ Prolapse (POP) trials