An interventional study of anterior or posterior colporrhaphy in Pelvic Organ Prolapse, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to female participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2022-05-27.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
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.
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.
676 studies on the registry are indexed under Prolapse; 79 are open to participants now.
This study's enrollment of 335 is above the median of 74 across 435 interventional studies indexed under Prolapse.
Browse Prolapse studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
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
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
will be performed in a traditional manner with midline plication of the fibromuscular layer using 2-0 delayed absorbable sutures.
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.
Time frame: From date of surgery until the date of first documented failure, assessed up to 2 years after surgery
Rate of anterior or posterior colporrhaphy
rate of anterior or posterior colporrhaphy performed during surgery
Time frame: At date of surgery
Change of POPQ values
point Ba, C, Bp and TVL
Time frame: From baseline to 2 years after surgery
Change of PFDI-20 scores
the PFDI-20 is a valid and reliable condition-specific quality-of-life questionnaires for women with pelvic floor disorders. It has 20 items and 3 scales (Pelvic Organ Prolapse Distress Inventory, Colorectal-Anal Distress Inventory and Urinary Distress Inventory). Each scale is scored from 0 to 100; higher scores indicate greater symptom burden. The PFDI-20 total score is obtained by adding the scores from the 3 scale scores together (0-300).
Time frame: From baseline to 2 years after surgery
Change of pelvic floor impact questionnaire (PFIQ-7) scores
the PFIQ-7 is a valid and reliable condition-specific quality-of-life questionnaires for women with pelvic floor disorders. It has 7 questions and each question has 3 separate responses (one for each of 3 scales; Urinary Impact Questionnaire, Colo-rectal-anal Impact Questionnaire, and Pelvic Organ Prolapse Impact Questionnaire). Each scale is scored from 0 to 100; higher scores indicate greater symptom burden. The PFIQ-7 total score is obtained by adding the scores from the 3 scales together (0-300).
Time frame: From baseline to 2 years after surgery
Change of Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ)-12 scores
the PISQ-12 is a valid and reliable condition-specific questionnaire that evaluates sexual function in women with urinary incontinence and/or pelvic organ prolapse. It has 12 items and responses are graded on a five-point Likert scale ranging from 0 to 4. A total of 48 is the maximum score; higher scores indicate better sexual function.
Time frame: From baseline to 2 years after surgery
Operating times
mean or median minutes of operating times
Time frame: At date of surgery
Estimated blood loss
mean or median mililiters of estimated blood loss
Time frame: At date of surgery
Length of hospital stay
mean or median days of hospital stay
Time frame: From date of admission to date of discharge, estimated average 4 days
Rate of adverse events
rate of cardiovascular, pulmonary, gastrointestinal, genitourinary, and neurological complications
Time frame: From date of surgery to 2 years after surgery
Plan to share: Undecided
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Seoul National University Hospital