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
Anterior/apical vaginal prolapse beyond the hymen (>0 on POPQ)
Urge-predominant mixed UI despite stable therapy
Advanced UUI/OAB 3rd line therapy treatment within 1 year of enrollment.
Planned hysterectomy, urethral or anterior/apical surgeries s requiring general anesthesia at the time of SUI treatment, during the last 6 months, or planned within the next 12 months.
NICHD Pelvic Floor Disorders Network
Lead sponsor
Duke University
Collaborator
Kaiser Permanente
Collaborator
University of Chicago
Collaborator
University of Pennsylvania
Collaborator
University of Texas Southwestern Medical Center
Collaborator
Women and Infants Hospital of Rhode Island
Collaborator
RTI International
Collaborator
University of California, San Diego
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator