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Study identifier: NCT06480227 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence

Condition: Stress Urinary Incontinence · Urinary Incontinence · Mixed Urinary Incontinence  ·  Sponsor: NICHD Pelvic Floor Disorders Network

PhaseNA
Planned participants358
Who can joinFemale, 21 Years to no upper limit
Healthy volunteersNo

About this study

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).

This description comes directly from the study's public registry record.

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Contact details are listed per location below or on the registry record.

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Locations (7)

University of California at San DiegoLa Jolla, California, United StatesRecruiting
Kaiser Permanente -- San DiegoSan Diego, California, United StatesRecruiting
University of ChicagoChicago, Illinois, United StatesRecruiting
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic SurgeryDurham, North Carolina, United StatesRecruiting
University of PennsylvaniaPhiladelphia, Pennsylvania, United StatesRecruiting
Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic SurgeryProvidence, Rhode Island, United StatesRecruiting
University of Texas Southwestern Medical CenterDallas, Texas, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06480227