Northwestern University
Chicago, Illinois, 60611, United States
NCT Number: NCT04880239
This study will examine whether surgeons should add a prophylactic posterior colpoperineorrhaphy to a mesh-augmented apical prolapse repair.
This study is active but is not currently recruiting participants.
18 year and older
Female
Interventional
Not applicable
Chicago, Illinois, 60611, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients having a sacralcolpopexy will be randomized to ultra lightweight mesh (Coloplast Restorelle) with posterior colpoperineorrhaphy or the same procedure without the posterior colpoperineorrhaphy
Time frame: 1 Year
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
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
To compare the rates of dyspareunia between groups using the Female Sexual Function Index (measured from 2-36 points)
Time frame: 2 Weeks
To compare the estimated blood loss (in milliliters) between groups.
Time frame: Day of surgery
To compare the operative time (in minutes as listed on the surgical case tracking) between groups.
Time frame: 2 Weeks
To compare postoperative pain scores using a visual analog scale (0-100 points) between groups.
Time frame: 2 Weeks
To compare narcotic pain medication use (in morphine equivalents consumed and reported by patients) between groups.
Northwestern University
Other
REDUCE Trial - Reducing Prolapse Recurrence by Reducing the Genital Hiatus
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05760794
Pathological Conditions, Anatomical, Pathological Conditions, Signs and Symptoms
Winston-Salem, North Carolina, United States
View Trial DetailsNCT05633901
Anxiety Disorders, Female Urogenital Diseases
Cincinnati, Ohio, United States
View Trial DetailsNCT06159777
Constipation, Pathological Conditions, Anatomical
Cleveland, Ohio, United States
View Trial DetailsNCT07194343
Pathological Conditions, Anatomical, Pathological Conditions, Signs and Symptoms
Barcelona, Spain
View Trial Details