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 range45 Years
SexMALE
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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
✕. 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)
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