Pelvic Organ Prolapse
Conditions
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.
Interventions
PROCEDUREanterior or posterior colporrhaphy
will be performed in a traditional manner with midline plication of the fibromuscular layer using 2-0 delayed absorbable sutures.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical success at 2 years after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of anterior or posterior colporrhaphy | At date of surgery | rate of anterior or posterior colporrhaphy performed during surgery |
| Change of PFDI-20 scores | 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). |
| Change of pelvic floor impact questionnaire (PFIQ-7) scores | From baseline to 2 years after surgery | 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). |
| Change of Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ)-12 scores | From baseline to 2 years after surgery | 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. |
| Change of POPQ values | From baseline to 2 years after surgery | point Ba, C, Bp and TVL |
| Estimated blood loss | At date of surgery | mean or median mililiters of estimated blood loss |
| Length of hospital stay | From date of admission to date of discharge, estimated average 4 days | mean or median days of hospital stay |
| Rate of adverse events | From date of surgery to 2 years after surgery | rate of cardiovascular, pulmonary, gastrointestinal, genitourinary, and neurological complications |
| Operating times | At date of surgery | mean or median minutes of operating times |
Countries
South Korea
Outcome results
None listed