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).

NCT Number	NCT06480227
Lead Sponsor	NICHD Pelvic Floor Disorders Network Collaborators: Duke University, Kaiser Permanente, University of Chicago, University of Pennsylvania, University of Texas Southwestern Medical Center, Women and Infants Hospital of Rhode Island, RTI International, University of California, San Diego, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions	Stress Urinary Incontinence, Urinary Incontinence, Mixed Urinary Incontinence
Enrollment	358 participants
Start Date	2024-08-28
Primary Completion	2028-12-31 (estimated)
Study Completion	2030-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-08