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 range30 Years

SexFEMALE

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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

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

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