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

Recruiting N/A Interventional Study
Stress Urinary Incontinence Urinary Incontinence Mixed Urinary Incontinence
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
21 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
358 (estimated)
Sponsor
NICHD Pelvic Floor Disorders Network · Research network
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 positi…
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