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

Pelvic Organ Prolapse Clinical Trial

Official title:

Preoperative POPQ Versus Simulated Apical Support as a Guideline for Anterior or Posterior Repair at the Time of Transvaginal Apical Suspension

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03187054
• Other study ID #: SNUH-1705-062-853
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 20, 2017
• Est. completion date: September 30, 2022

Study information

• Verified date: May 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 for anterior or posterior vaginal wall prolapse at the time of transvaginal apical suspension.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 335
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Myung Jae, Jeon	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of anterior or posterior colporrhaphy	rate of anterior or posterior colporrhaphy performed during surgery	At date of surgery
Secondary	Change of POPQ values	point Ba, C, Bp and TVL	From baseline to 2 years after surgery
Secondary	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).	From baseline to 2 years after surgery
Secondary	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).	From baseline to 2 years after surgery
Secondary	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.	From baseline to 2 years after surgery
Secondary	Operating times	mean or median minutes of operating times	At date of surgery
Secondary	Estimated blood loss	mean or median mililiters of estimated blood loss	At date of surgery
Secondary	Length of hospital stay	mean or median days of hospital stay	From date of admission to date of discharge, estimated average 4 days
Secondary	Rate of adverse events	rate of cardiovascular, pulmonary, gastrointestinal, genitourinary, and neurological complications	From date of surgery to 2 years after surgery