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.
Approximately 300,000 men undergo radical prostatectomy (RP) worldwide for the treatment of prostate cancer. RP has favorable oncology outcomes but carries risks of erectile dysfunction and urinary incontinence. Urinary incontinence after RP has negatively affects patient quality of life. The bioresorbable Voro Urologic Scaffold is designed to be placed over the anastomotic site during an RP procedure, between the bladder neck and urethral stump, to constrain the urethra immediately proximal to the urinary sphincter. The device is designed to relieve the load on the urinary sphincter. As the anastomosis heals, connective tissues form in the scaffold geometry while the scaffold material resorbs and hence potentially reduce the risk of acute and chronic stress incontinence. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
40
radical prostatectomy
National Hospital
Panama City, Punta Pacifica, Panama
The change in pad weight of 24-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups.
The pads are pre-weighed prior to providing them to subjects. The test should be started with an empty bladder. The subject will wear pads and perform their normal daily activities for 24 hours.
Time frame: Baseline, Foley removal (about 2-week post procedure), 6-week, and 3-, 6-, 12- & 24-months follow-ups.
The change in pad weight of 1-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups.
The 1-hour pad test follows a standard protocol. Prior to the 1-hour test, the subject is asked to ensure he is adequately hydrated. This will be determined by the color of the urine during the voiding prior to the start of the test. The urine must be clear or light yellow in color to start the test. If the urine is dark yellow, the subject should be given fluids to drink until the urine is light yellow or close to colorless (proper hydration). If voiding is urgent and unavoidable, the test is terminated. Collect voiding volume and repeat the test after re-hydration.
Time frame: Baseline, post-procedure 6-week, and 3-, 6-, 12- & 24-months follow-ups.
The changes in the standing cough test (SCT) from baseline to post procedure 6-month and 12-month follow-ups.
The subject must verbally confirm that they have not voided for at least 60 minutes prior to the examination. Examination of the urethral meatus is performed while the subject performs four forceful coughs. Towels or pads are held several inches from the meatus during coughs to collect any urinary leakage. Leakage is evaluated using the Male Stress Incontinence Grading Scale (MSIGS).
Time frame: Baseline, post-procedure 6-week, and 3-, 6-, 12- & 24-months follow-ups.
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