Actively Recruiting
Pivotal Study of Voro Urologic Scaffold
Led by Levee Medical, Inc. · Updated on 2026-05-01
266
Participants Needed
19
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pivotal Study of Voro Urologic Scaffold
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 45 years or older
- Diagnosed with prostate cancer and scheduled for radical prostatectomy
- Gleason Grade Group 4 or lower
- Prostate size less than 80 grams as measured by MRI
- Able and willing to provide written consent
- Able and willing to comply with study follow-up visits and procedures
- Willing to avoid other procedures for stress urinary incontinence during the study
You will not qualify if you...
- Malignant tumors with bladder neck or urethral sphincter invasion or metastatic disease
- History of urinary incontinence, including stress or urge incontinence
- Positive 1 hour pad weight test or reported incontinence episodes
- Currently treated with medications for overactive bladder
- Post void residual greater than 200 ml or greater than 25% total volume
- Presence or history of urethral stricture or bladder neck contracture
- Current or chronic urinary tract infection
- Prior urologic outlet surgery or minimally invasive procedure
- Prior pelvic radiation or planned radiation after prostatectomy
- History of neurogenic lower urinary tract dysfunction
- History or current need for intermittent urinary catheterization
- Body mass index over 40
- History of cancer (other than eligible prostate cancer) not in complete 5-year remission
- History of bladder malignancy
- Diagnosed or suspected neurologic conditions affecting voiding
- History of significant congestive heart failure (NYHA Class III or IV)
- Current uncontrolled diabetes (HbA1c ≥ 7.5%)
- Overactive bladder score above 8 on baseline questionnaire
- History of immunosuppressive conditions or immune-modulating medications
- Any significant medical history posing unreasonable risk or unsuitability
- Planned concomitant surgery
- Anterior fascial sparing or Retzius sparing radical prostatectomy
- Participation in other investigational studies without sponsor approval
- Considered a vulnerable population by investigator judgment
- Planned adjuvant radiation therapy
AI-Screening
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Trial Site Locations
Total: 19 locations
1
Mayo Clinic
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Academic Urology
Sun City, Arizona, United States, 85351
Actively Recruiting
3
University of California Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
4
University of California San Diego
San Diego, California, United States, 92093
Actively Recruiting
5
Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
6
University of Chicago Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
7
IU school of Medicine, Department of Urology
Indianapolis, Indiana, United States, 46202
Actively Recruiting
8
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
9
John Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
10
BMHCC/ Mississippi Urology Clinic
Jackson, Mississippi, United States, 39202
Actively Recruiting
11
Northwell Health
New Hyde Park, New York, United States, 11042
Actively Recruiting
12
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
13
University of Rochester Medical Center
Rochester, New York, United States, 14620
Actively Recruiting
14
Erlanger Urology
Chattanooga, Tennessee, United States, 37403
Actively Recruiting
15
The Conrad Pearson Clinic
Germantown, Tennessee, United States, 38138
Actively Recruiting
16
Urology Associates PC Nashville
Nashville, Tennessee, United States, 37209
Actively Recruiting
17
Urology of Austin
Austin, Texas, United States, 78759
Actively Recruiting
18
Potomac Urology Center
Alexandria, Virginia, United States, 22311
Actively Recruiting
19
Urology of Virginia, PLLC
Virginia Beach, Virginia, United States, 23462
Actively Recruiting
Research Team
K
Karen Cornett
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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