Actively Recruiting
A Pivotal Study of Voro Urologic Scaffold for Post Prostatectomy Stress Urinary Incontinence (ARID II)
Led by Levee Medical, Inc. · Updated on 2026-06-01
266
Participants Needed
19
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the Voro Urologic Scaffold in adult men undergoing robotic assisted radical prostatectomy, compared to a control group without the scaffold. This pivotal, multi-center, single-blind, randomized controlled trial involves up to 266 participants treated across up to 30 centers in the United States. The study focuses on men with prostate cancer who are scheduled for surgery and aims to assess outcomes related to urinary incontinence after the procedure. Participants will be randomly assigned to one of two groups. One group will receive the Voro Urologic Scaffold implanted during the robotic assisted radical prostatectomy after removal of the prostate. The other group will undergo the same prostatectomy procedure as standard care but without scaffold placement. The study includes a Baseline visit, implantation during surgery, catheter removal, and follow-up visits at 6 weeks, 6 months, 12 months, 18 months, and 24 months post-prostatectomy. Throughout the study, participants will undergo assessments including the 1-hour provocative pad weight test to measure continence at multiple time points, and quality of life evaluations using the urinary domain of the Expanded Prostate Cancer Index Composite (EPIC) Questionnaire. Researchers will monitor adverse events up to 24 months and track continence rates at 6 weeks, 6 months, and 12 months. Participants will be evaluated regularly during follow-up visits to assess safety and treatment effects over two years.
CONDITIONS
Brief 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 measured by MRI
- Able and willing to provide written consent
- Able and willing to comply with study visits and procedures
- Willing to avoid other treatments for stress urinary incontinence during the study
You will not qualify if you...
- Malignant tumors invading bladder neck or urethral sphincter or metastatic disease
- History of urinary incontinence including stress or urge types
- Positive stress urinary incontinence test or reported episodes
- Currently treated with medications for overactive bladder
- Post void residual volume over 200 ml or over 25% of 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 procedures
- Prior pelvic radiation or planned radiation after prostatectomy
- History of neurogenic lower urinary tract dysfunction
- History or need for intermittent urinary catheterization
- Body mass index over 40
- History of other cancers not in complete remission for 5 years
- History of bladder malignancy
- Primary neurologic conditions affecting voiding
- Significant congestive heart failure (NYHA Class III or IV)
- Uncontrolled diabetes (HbA1c >=7.5%)
- Overactive bladder score over 8 on baseline questionnaire
- History of immunosuppressive conditions or therapies
- Significant medical history posing risk or unsuitability
- Planned concomitant surgery
- Anterior fascial sparing or Retzius sparing radical prostatectomy
- Participation in other investigational studies without sponsor approval
- Vulnerable populations including prisoners or those with cognitive or psychiatric conditions
- Planned adjuvant radiation therapy
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants undergo robotic assisted radical prostatectomy as part of their standard care. The Voro Urologic Scaffold is placed during the prostatectomy procedure after prostate removal for those in the scaffold group.
1 surgical procedure (in-person)
Duration - Up to 24 months
Participants are monitored for safety and continence outcomes following surgery and scaffold placement if applicable.
Visits at 6 weeks, 6 months, and 12 months post-prostatectomy
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
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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