- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03187054
POPQ Versus Simulated Apical Support as a Guideline for Anterior or Posterior Repair During Vaginal Reconstruction
Preoperative POPQ Versus Simulated Apical Support as a Guideline for Anterior or Posterior Repair at the Time of Transvaginal Apical Suspension
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Seoul, Korea, Republic of, 03080
- Myung Jae, Jeon
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: POPQ-based surgery
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)
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will be performed in a traditional manner with midline plication of the fibromuscular layer using 2-0 delayed absorbable sutures.
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Experimental: Simulated apical support-based surgery
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)
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will be performed in a traditional manner with midline plication of the fibromuscular layer using 2-0 delayed absorbable sutures.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surgical success at 2 years after surgery
Time Frame: From date of surgery until the date of first documented failure, assessed up to 2 years after surgery
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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.
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From date of surgery until the date of first documented failure, assessed up to 2 years after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of anterior or posterior colporrhaphy
Time Frame: At date of surgery
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rate of anterior or posterior colporrhaphy performed during surgery
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At date of surgery
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Change of POPQ values
Time Frame: From baseline to 2 years after surgery
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point Ba, C, Bp and TVL
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From baseline to 2 years after surgery
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Change of PFDI-20 scores
Time Frame: From baseline to 2 years after surgery
|
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).
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From baseline to 2 years after surgery
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Change of pelvic floor impact questionnaire (PFIQ-7) scores
Time Frame: From baseline to 2 years after surgery
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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).
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From baseline to 2 years after surgery
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Change of Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ)-12 scores
Time Frame: From baseline to 2 years after surgery
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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.
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From baseline to 2 years after surgery
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Operating times
Time Frame: At date of surgery
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mean or median minutes of operating times
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At date of surgery
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Estimated blood loss
Time Frame: At date of surgery
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mean or median mililiters of estimated blood loss
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At date of surgery
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Length of hospital stay
Time Frame: From date of admission to date of discharge, estimated average 4 days
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mean or median days of hospital stay
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From date of admission to date of discharge, estimated average 4 days
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Rate of adverse events
Time Frame: From date of surgery to 2 years after surgery
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rate of cardiovascular, pulmonary, gastrointestinal, genitourinary, and neurological complications
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From date of surgery to 2 years after surgery
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SNUH-1705-062-853
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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