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

NCT03187054 | Unknown

• 1 other identifier: SNUH-1705-062-853
• Study Type: interventional
• Target: 335
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• Surgical success at 2 years after surgery

  surgical success is defined as the absence of all of the following criteria: (1) anterior or posterior vaginal descent beyond the hymen (i.e., point Ba or Bp \>0); (2) descent of the vaginal apex beyond the half-way point of vagina (i.e., point C \> -1/2×total vaginal length); (3) vaginal bulge symptoms; (4) re-treatment for prolapse by either surgery or pessary.

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

Secondary Outcomes (9)

• Rate of anterior or posterior colporrhaphy

  At date of surgery

• Change of POPQ values

  From baseline to 2 years after surgery

• Change of PFDI-20 scores

  From baseline to 2 years after surgery

• Change of pelvic floor impact questionnaire (PFIQ-7) scores

  From baseline to 2 years after surgery

• Change of Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ)-12 scores

  From baseline to 2 years after surgery

Study Arms (2)

POPQ-based surgery

ACTIVE COMPARATOR

will undergo anterior or posterior colporrhaphy for all of anterior or posterior vaginal prolapse stage 2 or greater (i.e. point Ba or Bp ≥-1 on the POPQ examination)

Procedure: anterior or posterior colporrhaphy

Simulated apical support-based surgery

EXPERIMENTAL

will undergo anterior or posterior colporrhaphy only for the prolapse unresolved under simulated apical support (i.e. point Ba or Bp ≥-1 under simulated apical support)

Procedure: anterior or posterior colporrhaphy

Interventions

anterior or posterior colporrhaphy PROCEDURE

will be performed in a traditional manner with midline plication of the fibromuscular layer using 2-0 delayed absorbable sutures.

POPQ-based surgery; Simulated apical support-based surgery

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Myung Jae, Jeon

Seoul, 03080, South Korea

Location

Related Publications (1)

• Jeon MJ, Kim CH, Cho HH, Suh DH, Kim SR. Preoperative POPQ versus Simulated Apical Support as a Guideline for Anterior or Posterior Repair at the Time of Transvaginal Apical Suspension (PREPARE trial): study protocol for a randomised controlled trial. BMJ Open. 2020 Jan 6;10(1):e034170. doi: 10.1136/bmjopen-2019-034170.

  PMID: 31911524 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Myung Jae Jeon, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 14, 2017
• Study Start: June 20, 2017
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

KR (1)