UnknownNot Applicable

POPQ Versus Simulated Apical Support as a Guideline for Anterior or Posterior Repair During Vaginal Reconstruction

South Korea335 participantsStarted 2017-06-20

Plain-language summary

The objective of the Preoperative Pelvic Organ Prolapse Quantification (POPQ) versus Simulated Apical Support as a Guideline for Anterior or Posterior Repair at the Time of Transvaginal Apical Suspension (PREPARE) trial is to compare surgical outcomes of POPQ-based surgery with simulated apical support-based surgery for anterior or posterior vaginal wall prolapse at the time of transvaginal apical suspension.

Who can participate

Age range

30 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: * POPQ stage 2-4 prolapse * Descent of vaginal apex or cervix at least ½ way into vaginal canal (i.e. POPQ point C ≥ -TVL/2) * Correction of either anterior or posterior vaginal wall prolapse under simulated apical support (i.e. from stage 2 or greater to stage 0 or 1) * Vaginal bulge symptoms (i.e. an affirmative response to the question 3 from the PFDI-20) * Vaginal reconstructive surgery is planned, including a vaginal apical suspension procedure Exclusion Criteria: * Large pelvic mass * Previous prolapse surgery * Known malignancy * Two or more inpatient hospitalizations for medical comorbidities in the previous year * Subject wishes to retain her uterus * Subject is unable and unwilling to participate in

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

Surgical success at 2 years after surgery

Timeframe: From date of surgery until the date of first documented failure, assessed up to 2 years after surgery

Trial details

NCT IDNCT03187054

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-30

View on ClinicalTrials.gov More Pelvic Organ Prolapse trials