The objective of this study is to evaluate the safety and performance of the Voro Urologic Scaffold as a prophylactic treatment for post-prostatectomy stress urinary incontinence. The study is a prospective, multicenter, single arm study. Up to 40 subjects will be treated at up to 3 investigational sites in Panama. Subjects will be followed up post-treatment at catheter removal, 6 weeks post prostatectomy, 3 months, 6 months, 12 months and 2 years.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
The change in pad weight of 24-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups.
Timeframe: Baseline, Foley removal (about 2-week post procedure), 6-week, and 3-, 6-, 12- & 24-months follow-ups.