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

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Stress Urinary Incontinence, Pelvic Floor Disorders

In brief

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.

Key facts

Study ID

NCT04586166

Run by

Wake Forest University Health Sciences

People needed

180

Starts

2020-12-23

Expected to finish

2032-12-31

Last updated by the study team

2026-04-02

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• At least 21 years of age
• Vaginal bulge symptoms as indicated by an affirmative response of >1 to question 3 of the PFDI-SF20
• POP ≥ stage II according to the pelvic organ prolapse quantification (POP-Q) system45, with evidence of apical descent
• Women being considered for minimally invasive sacrocolpopexy (with or without concomitant hysterectomy)
• Objective SUI: positive standardized cough stress test on clinical examination or on urodynamic study with reduced prolapse
• Understanding and acceptance of the need to return for all scheduled follow-up visits and willing to complete study questionnaires
• Able to give informed consent

You may not qualify if…

• Prior surgery for stress urinary incontinence including mid-urethral sling; Burch/MMK; fascial pubovaginal sling (autologous, xenograft or allograft); and urethral bulking injection
• Any serious disease, or chronic condition, that could interfere with the study compliance
• Unwilling to have a synthetic sling
• Untreated and unresolved urinary tract infection
• Poorly-controlled diabetes mellitus (HgbA1c > 9 within 3 months of surgery date)
• Neurogenic bladder/ pre-operative self-catheterization
• Elevated post-void residual/PVR (>150 ml) that does not resolve with prolapse reduction testing (pessary, prolapse reduced uroflow or micturition study)
• Prior pelvic radiation
• Inflammatory bowel disease
• Current genitourinary fistula or urethral diverticulum
• Planned concomitant bowel related surgery including sphincteroplasty and perineal rectal prolapse surgery, rectovaginal fistula repair, hemorrhoidectomy
• Pregnant or Planning to Conceive
• Incarcerated

Where it is running

• Florida Robotic and Minimally Invasive Urogynecology — Coconut Creek, Florida, United States
• Augusta University — Augusta, Georgia, United States
• Northwestern Medicine — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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