Pelvic Organ ProlapseNCT03187054
POPQ Versus Simulated Apical Support as a Guideline for Anterior or Posterior Repair During Vaginal Reconstruction
A study testing anterior or posterior colporrhaphy in people with Pelvic Organ Prolapse, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- anterior or posterior colporrhaphy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jun 2017to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative POPQ Versus Simulated Apical Support as a Guideline for Anterior or Posterior Repair at the Time of Transvaginal Apical Suspension
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.
Read the 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.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- anterior or posterior colporrhaphy
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior or posterior colporrhaphyProcedure or surgery
will be performed in a traditional manner with midline plication of the fibromuscular layer using 2-0 delayed absorbable sutures.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Procedure: anterior or posterior colporrhaphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
rate of anterior or posterior colporrhaphy performed during surgery
Measured: At date of surgery
Change of POPQ values
point Ba, C, Bp and TVL
Measured: 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).
Measured: 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).
Measured: 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.
Measured: From baseline to 2 years after surgery
Operating times
mean or median minutes of operating times
Measured: At date of surgery
Estimated blood loss
mean or median mililiters of estimated blood loss
Measured: At date of surgery
Length of hospital stay
mean or median days of hospital stay
Measured: 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
Measured: From date of surgery to 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start20 Jun 2017
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myung Jae Jeon, Seoul National University Hospital
- Investigators
- Myung Jae Jeon, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187054
- Sponsor's protocol ID
- SNUH-1705-062-853
- Status last verified
- May 2022
- First submitted
- 9 Jun 2017
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31911524
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative POPQ Versus Simulated Apical Support as a Guideline for Anterior or Posterior Repair at the Time of Transvaginal Apical Suspension
- ClinicalTrials.gov ID
- NCT03187054
- Acronym / sponsor ID
- SNUH-1705-062-853
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POPQ-based surgery | Active comparator | Procedure: anterior or posterior colporrhaphywill 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) |
| Simulated apical support-based surgery | Experimental | Procedure: anterior or posterior colporrhaphywill 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) |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anterior or posterior colporrhaphywill be performed in a traditional manner with midline plication of the fibromuscular layer using 2-0 delayed absorbable sutures. | Procedure or surgery | POPQ-based surgery, Simulated apical support-based surgery |
Primary outcome
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
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.
9 secondary outcomes
Rate of anterior or posterior colporrhaphy
Time frame: At date of surgery
Change of POPQ values
Time frame: From baseline to 2 years after surgery
Change of PFDI-20 scores
Time frame: From baseline to 2 years after surgery
Change of pelvic floor impact questionnaire (PFIQ-7) scores
Time frame: From baseline to 2 years after surgery
Change of Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ)-12 scores
Time frame: From baseline to 2 years after surgery
Operating times
Time frame: At date of surgery
Estimated blood loss
Time frame: At date of surgery
Length of hospital stay
Time frame: From date of admission to date of discharge, estimated average 4 days
Rate of adverse events
Time frame: From date of surgery to 2 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Derived from this study: PubMed 31911524Jeon 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myung Jae Jeon, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anterior or posterior colporrhaphy in people with Pelvic Organ Prolapse, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03187054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.