Pivotal Study of Voro Urologic Scaffold (NCT06873581)
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (30 items).
Location: Mayo Clinic — Phoenix, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
- History of urethral stricture
- Current or chronic urinary tract infection
- Prior urologic outlet surgical or minimally invasive procedure (e.g., Transurethral resection of the prostate \[TURP\], Holmium laser enucleation of the prostate \[HoLEP,\] Rezum, etc.).
- Prior pelvic radiation or anticipated need for radiation after radical prostatectomy
- History of neurogenic lower urinary tract dysfunction
- History or current need for intermittent urinary catheterization
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (19 Sites)
- Mayo Clinic — Phoenix, Arizona
- Academic Urology — Sun City, Arizona
- University of California Los Angeles — Los Angeles, California
- University of California San Diego — San Diego, California
- Tampa General Hospital — Tampa, Florida
- University of Chicago Medicine — Chicago, Illinois
- IU school of Medicine, Department of Urology — Indianapolis, Indiana
- University of Maryland — Baltimore, Maryland
- John Hopkins — Baltimore, Maryland
- BMHCC/ Mississippi Urology Clinic — Jackson, Mississippi
- Northwell Health — New Hyde Park, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- University of Rochester Medical Center — Rochester, New York
- Erlanger Urology — Chattanooga, Tennessee
- The Conrad Pearson Clinic — Germantown, Tennessee
- Urology Associates PC Nashville — Nashville, Tennessee
- Urology of Austin — Austin, Texas
- Potomac Urology Center — Alexandria, Virginia
- Urology of Virginia, PLLC — Virginia Beach, Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.