Overview
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.
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).
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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