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Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
Sponsor: NICHD Pelvic Floor Disorders Network
Summary
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).
Official title: A Randomized Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
Key Details
Gender
FEMALE
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
358
Start Date
2024-08-28
Completion Date
2030-01-01
Last Updated
2025-12-31
Healthy Volunteers
No
Interventions
Solyx Single-incision Sling
Minimally invasive mesh device placed to treat stress urinary incontinence.
Bulkamid Transurethral Bulking Agent
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
Locations (7)
University of California at San Diego
La Jolla, California, United States
Kaiser Permanente -- San Diego
San Diego, California, United States
University of Chicago
Chicago, Illinois, United States
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery
Providence, Rhode Island, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States