A Randomized Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
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).
• 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.