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
Wake Forest University Health Sciences
180 participants
Dec 23, 2020
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria13
- 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
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Interventions
Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure.
Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure.
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT04586166