This study will examine whether surgeons should add a prophylactic posterior colpoperineorrhaphy to a mesh-augmented apical prolapse repair.
The decision to perform a posterior colpoperineorrhaphy at the time of sacrocolpopexy is controversial. Based on cohort data, some surgeons advocate that sacrocolpopexy alone is effective at treating posterior vaginal wall prolapse and the addition of posterior colpoperineorrhaphy only increases the likelihood of pain with defecation and dyspareunia. Experts theorize that placement of posterior vaginal mesh down to the perineal body provides adequate posterior support and reduces genital hiatus size. Others argue that placement of mesh too low on the posterior vagina may be associated with increased mesh exposure and pain secondary to mesh stiffness. No randomized trials exist comparing prolapse outcomes using new, ultra-light polypropylene mesh with and without posterior colpoperineorrhaphy. The investigators hypothesize that there will be no difference in prolapse outcomes after sacrocolpopexy using Restorelle mesh with and without posterior colpoperineorrhaphy. However, patients with a posterior colpoperineorrhaphy will be more likely to report pain with defecation and dyspareunia. This will be the first multicenter randomized trial comparing outcomes of sacrocolpopexy with and without posterior colpoperineorrhaphy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Patients having a sacralcolpopexy will be randomized to ultra lightweight mesh (Coloplast Restorelle) with posterior colpoperineorrhaphy or the same procedure without the posterior colpoperineorrhaphy
Northwestern University
Chicago, Illinois, United States
Pelvic Organ Prolapse Quantification (POP-Q) System
The POP-Q System will be used to compare the rate of prolapse recurrence at 1 year between women undergoing a sacrocolpopexy with Restorelle mesh with and without a concomitant posterior colpoperineorrhaphy.
Time frame: 1 Year
Defecatory Dysfunction
To compare the rates of defecatory dysfunction using the Bristol Stool Scale (stool types measured from type 1-type 7) and the Colorectal-Anal Distress Inventory 8 (measured from 0-100 points).
Time frame: 1 Year
Dyspareunia
To compare the rates of dyspareunia between groups using the Female Sexual Function Index (measured from 2-36 points)
Time frame: 1 Year
Surgical and Perioperative Events: Blood Loss
To compare the estimated blood loss (in milliliters) between groups.
Time frame: 2 Weeks
Surgical and Perioperative Events: Operative Time
To compare the operative time (in minutes as listed on the surgical case tracking) between groups.
Time frame: Day of surgery
Surgical and Perioperative Events: Postoperative Pain
To compare postoperative pain scores using a visual analog scale (0-100 points) between groups.
Time frame: 2 Weeks
Surgical and Perioperative Events: Pain Medication Use
To compare narcotic pain medication use (in morphine equivalents consumed and reported by patients) between groups.
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Time frame: 2 Weeks