Pivotal Study of Voro Urologic Scaffold (NCT06873581) | Clinical Trial Compass
RecruitingPhase 3
Pivotal Study of Voro Urologic Scaffold
United States266 participantsStarted 2025-04-18
Plain-language summary
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.
Who can participate
Age range
45 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male \>= 45 years of age of any race and ethnic group
. Diagnosed with prostate cancer and scheduled for radical prostatectomy
. Gleason Grade Group 4 or lower
. Prostate size less than 80 grams, as measured by Magnetic Resonance Imaging (MRI)
. Able and willing to provide written consent to participate in the study
. Able and willing to comply with study follow-up visits and procedures
. Willing to forego any other procedures for stress urinary incontinence (SUI) during the study
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with adverse events (AEs)
Timeframe: Upto 24 months
2
Number of Participants With Adverse Events Categorized by Severity
Timeframe: Upto 24 months
3
Number of participants achieving continence as measured by 1 hour provocative pad weight test at 6 weeks post-prostatectomy
. Malignant tumors with known bladder neck or urethral sphincter invasion or metastatic disease confirmed via baseline assessments (example \[e.g.,\] Multiparametric magnetic resonance imaging \[mpMRI\], bone scan)
. History of urinary incontinence, including stress or urge urinary incontinence
. Demonstration of SUI, such as positive 1 hour pad weight test or participant reported incontinence episodes
. Currently treated with medications to treat overactive bladder (OAB)
. Post void residual \>200 milliliter (ml) or \> 25 percentage (%) total volume(= voided volume + residual volume)
. Presence of urethral stricture or bladder neck contracture