Ignite Creation Date:
2024-05-06 @ 10:21 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03236922
Status:
UNKNOWN
Last Update Posted:
2017-08-02
First Post:
2016-08-21
Brief Title:
Autologous Slings With Vesico-Vaginal Fistula Repair
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Pubococcygeus Versus Rectus Sheath Sling for Goh Class 3 and 4 Vesico-vaginal Fistulas a Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2017-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
It is clear from multiple accounts in the literature that patients with a vesico-vaginal fistula VVF involving the bladder neck andor proximal urethra have a high likelihood of residual incontinence Performing subsequent surgeries after the initial VVF repair risks additional complications Therefore placement of an autologous sling at the time of initial VVF repair would not only assist in covering the fistula but would also imitate the physiologic support that would theoretically improve urethral function A rectus fascia sling would most naturally provide this support and warrants testing against the success of the PC sling
Using the Goh scoring criteria Goh class 3 and 4 VVFs are the type most involving the urethra Therefore this group of patients is the target population for this study As there is currently no standard of care for repairing large urethral defects this procedural technique combined with otherwise standardized fistula repair would not introduce any foreseeable harm to patients
Using the Goh scoring criteria Goh class 3 and 4 VVFs are the type most involving the urethra Therefore this group of patients is the target population for this study As there is currently no standard of care for repairing large urethral defects this procedural technique combined with otherwise standardized fistula repair would not introduce any foreseeable harm to patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None