Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-02 @ 2:51 AM
Study NCT ID:
NCT04586166
Status:
RECRUITING
Last Update Posted:
2025-04-29
First Post:
2020-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
SASS: Randomized Trial of Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for Concomitant Management of Stress Urinary Incontinence During Minimally Invasive Sacrocolpopexy
Status:
RECRUITING
Status Verified Date:
2025-04
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:
SASS
Brief Summary:
SASS (Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy) will be a multicenter, prospective, randomized, single-blind non-inferiority trial.
Detailed Description:
SASS aims to compare the efficacy of a single-incision (SIS) versus a retropubic mid-urethral sling (RP) placed at the time of minimally invasive sacrocolpopexy in women with pelvic organ prolapse and objectively confirmed stress urinary incontinence (SUI).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: