Clinical trial NCT03187054: POPQ Versus Simulated Apical Support as a Guideline for Anterior or Posterior Repair During Vaginal Reconstruction
Official title: Preoperative POPQ Versus Simulated Apical Support as a Guideline for Anterior or Posterior Repair at the Time of Transvaginal Apical Suspension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 335
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The PREPARE trial is a prospective, randomized trial conducted with the aim to determine non-inferiority of the primary outcome between POPQ-based surgery and simulated apical support-based surgery for anterior or posterior vaginal wall prolapse. Participants will undergo transvaginal surgery for prolapse, including the assigned procedure for anterior or posterior vaginal prolapse under general or spinal anesthesia. Concomitant procedures will be performed as intended prior to surgery. Women with a uterus in situ will undergo hysterectomy and all women will receive transvaginal vault suspension, including uterosacral ligament suspension, sacrospinous ligament fixation, and iliococcygeal suspension with both delayed absorbable and permanent sutures, according to the preference of surgeon. Incontinence surgery will also be performed for women with documented urodynamic stress incontinence.

A standardized protocol for enrollment, treatment and data collection will be employed by all sites. The study will be a single-blind study, as it is impossible to blind the study surgeon for the surgical procedure to which the subject in assigned. However, it is our intent that when feasible and ethical, all outcomes assessors and the subjects will be blinded to the treatment assignment. Postoperative follow-up will take place after 5 weeks and 6, 12, and 24 months. Patients will undergo a standard gynecological examination including POPQ and fill in questionnaires.

Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Rate of anterior or posterior colporrhaphy
timeFrame: At date of surgery
measure: Change of POPQ values
timeFrame: From baseline to 2 years after surgery
measure: Change of PFDI-20 scores
timeFrame: From baseline to 2 years after surgery
measure: Change of pelvic floor impact questionnaire (PFIQ-7) scores
timeFrame: From baseline to 2 years after surgery
measure: Change of Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ)-12 scores
timeFrame: From baseline to 2 years after surgery
measure: Operating times
timeFrame: At date of surgery
measure: Estimated blood loss
timeFrame: At date of surgery
measure: Length of hospital stay
timeFrame: From date of admission to date of discharge, estimated average 4 days
measure: Rate of adverse events
timeFrame: From date of surgery to 2 years after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Myung Jae, Jeon
Study officials:
affiliation: Seoul National University Hospital
name: Myung Jae Jeon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.