Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04880239
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2021-04-14
Brief Title:
REDUCE Trial- Reducing Prolapse Recurrence
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
REDUCE Trial - Reducing Prolapse Recurrence by Reducing the Genital Hiatus
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine whether surgeons should add a prophylactic posterior colpoperineorrhaphy to a mesh-augmented apical prolapse repair
Detailed Description:
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None