NICHD Pelvic Floor Disorders Network
This is a multicentered, double-blind, randomized controlled, surgical trial of 358 women with inadequate symptom relief of stress urinary incontinence (SUI) or stress predominant mixed urinary incontinence (MUI) after conservative care. The Primary Aim is to determine the comparative effectiveness (as defined by "much" or "very much" better on PGI-I) of transurethral bulking agent (TBA) \[for 1 or 2 injections in 12 months\] vs. single-incision sling (SIS) 12 months after treatment intervention in women with predominant stress urinary incontinence (SUI).
The BASIS trial is a multicentered, double-blind, randomized controlled, surgical trial with two active interventions, 1) a transurethral bulking agent (TBA) or 2) a single-incision sling (SIS). Both interventions are FDA-approved treatment options for urinary incontinence and will be used in line with their approved use. Participants will be randomly assigned to one of the interventions. A total of 358 women will be randomized 1:1 to TBA or SIS. All participants will have data including demographics, medical history, and quality of life assessments as they relate to urinary incontinence coll…
Inclusion Criteria: * Women ≥ 21 years * For \> 3 months, bothersome SUI (response of somewhat, moderately, or quite a bit) without UUI or stress-predominant MUI. For those with equal bother of UUI and SUI, clinician determination that SUI is more severe/significant than UUI is required. * A positive cough stress test on standardized non-invasive testing or urodynamic SUI within the past 18 months. * Normal PVR \< 150 mL * Candidate for either study procedure as determined by treating surgeon * Available for up to 3 years. * Agrees to randomization. Exclusion Criteria: * Anterior/apical vag…
Minimally invasive mesh device placed to treat stress urinary incontinence.
Minimally invasive bulking agent injections used to bulk up the tissue surrounding the urethra to treat stress urinary incontinence. Up to 2 treatments within 12 months are allowed