NASHA Dx for Stress Urinary Incontinence
(NASHA-DX Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Prospective, randomized, single-blind study to evaluate the safety and efficacy of NASHA Dx investigational device compared to controlled device Bulkamid in adult women with mild, moderate and intrinsic sphincter deficiency (ISD).
Are You a Good Fit for This Trial?
This trial is for adult women who have mild to moderate stress urinary incontinence, including those with intrinsic sphincter deficiency. Participants should not have conditions that would make the procedure unsafe or interfere with study results.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- NASHA Dx Urethral Bulking System
Trial Overview
The study compares two treatments—NASHA Dx and Bulkamid—which are both injectable bulking agents used to treat stress urinary incontinence by helping the urethra close better. Women are randomly assigned to one of these treatments.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Investigational device
Control device
Find a Clinic Near You
Who Is Running the Clinical Trial?
Palette Life Sciences, Inc.
Lead Sponsor
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