At a glance
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Platelet-Rich Plasma Injection for the Treatment of Female Stress Urinary Incontinence: A Randomized Placebo-Controlled Study
In Brief
A Phase 3 clinical trial evaluating Platelet-rich plasma injection for Urinary Incontinence,Stress and Urinary Incontinence. Completed, enrolled 50 participants across 1 site.
Detailed Summary
The aim of this randomized controlled trial study is to evaluate the efficacy and safety of platelet-rich plasma (PRP) in the treatment of female stress urinary incontinence (SUI), compared to placebo. Subjects will undergo an injection of PRP (or injectable saline placebo) into the anterior vaginal wall in the office. Primary outcomes will include a negative urinary stress test plus improvement with the Patient Global Impression of Improvement (PGI-I) at 6-months. Secondary outcomes will include the Female Sexual Function Index (FSFI), the Incontinence Quality of life (I-QOL), Questionnaire for Urinary Incontinence Diagnosis (QUID), and the visual analog scale for pain.
Study Details
Timeline
Interventions
Injection of autologous platelet-rich plasma into the anterior vaginal wall