NCT04586166

Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy

SASS: Randomized Trial of Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for Concomitant Management of Stress Urinary Incontinence During Minimally Invasive Sacrocolpopexy

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Stress Urinary Incontinence
• Pelvic Floor Disorders

Interventions

Type	Name	Description
DEVICE	RP Sling	Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure.
DEVICE	SIS	Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure.

Timeline

• Start date: 2020-12-23
• Primary completion: 2031-12-31
• Completion: 2032-12-31
• First posted: 2020-10-14
• Last updated: 2026-04-02

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study