The objective of this study is to compare safety and effectiveness of the Voro Urologic Scaffold in adult men undergoing robotic assisted radical prostatectomy as compared to control arm. The study is a multi-center, single blind, randomized, controlled trial. Up to 266 participants will be treated at up to 30 centers in the United States. The study will consist of a Baseline visit, implantation during robotic assisted radical prostatectomy (RARP), catheter removal, 6 weeks, 6 months, 12 months, 18 months, and 24 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
266
The Voro Urologic Scaffold is placed during the prostatectomy procedure after prostate removal.
Mayo Clinic
Phoenix, Arizona, United States
RECRUITINGAcademic Urology
Sun City, Arizona, United States
RECRUITINGUCLA Urology
Los Angeles, California, United States
NOT_YET_RECRUITINGUniversity of California San Diego
San Diego, California, United States
RECRUITINGTampa General Hospital
Tampa, Florida, United States
RECRUITINGUniversity of Chicago Medicine
Chicago, Illinois, United States
RECRUITINGIU school of Medicine, Department of Urology
Indianapolis, Indiana, United States
RECRUITINGUniversity of Maryland
Baltimore, Maryland, United States
RECRUITINGJohn Hopkins
Baltimore, Maryland, United States
RECRUITINGCorewell Health William Beaumont University Hospital
Royal Oak, Michigan, United States
NOT_YET_RECRUITING...and 10 more locations
Number of participants with adverse events (AEs)
AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants during the course of the study, whether or not related to the investigational device.
Time frame: Upto 24 months
Number of Participants With Adverse Events Categorized by Severity
The severity of adverse events as assessed by the investigator; events will be based on the definitions outlined in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: Upto 24 months
Number of participants achieving continence as measured by 1 hour provocative pad weight test at 6 weeks post-prostatectomy
Time frame: At 6 weeks post-prostatectomy
Severity of incontinence as measured by 1 hour provocative pad weight test at 6 weeks
Time frame: At 6 weeks
Severity of incontinence as measured by 1 hour provocative pad weight test at 6 months
Time frame: At 6 months
Quality of Life (QoL) performance as assessed by the urinary domain of Expanded Prostate Cancer Index Composite (EPIC) Questionnaire
The Expanded Prostate Cancer Index Composite is a validated, comprehensive questionnaire designed to evaluate patient function and bother after localized prostate cancer treatment. Response options for each item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better quality of life.
Time frame: At 6 weeks, 6 months and 12 months
Continence rate as measured by 1-hour provocative pad weight test at 6 months post-prostatectomy
Time frame: At 6 months post-prostatectomy
Number of participants achieving continence as measured by 1 hour provocative pad weight test at 12 months post-prostatectomy
Time frame: At 12 months post-prostatectomy
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