Radical ProstatectomyPhase 3ARID IINCT06873581
Pivotal Study of Voro Urologic Scaffold
A Phase 3 study testing Voro Urologic Scaffold in people with Radical Prostatectomy and Stress Urinary Incontinence (SUI), run by Levee Medical, Inc. at 19 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Radical Prostatectomy, Stress Urinary Incontinence (SUI)
- What is being tested?
- Voro Urologic Scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 19 sitesUnited States
- Study dates
- 18 Apr 2025to 30 Apr 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- Body mass index >40
- History of cancer (excluding prostate cancer meeting the inclusion criteria) which is not considered in complete 5 year remission (excluding squamous and basal cell skin carcinoma)
- History of bladder malignancy
- Diagnosed or suspected primary neurologic conditions known to affect voiding function
- History of clinically significant congestive heart failure (i.e., New York Heart Association [NYHA] Class III and IV)
- Current uncontrolled diabetes (i.e., hemoglobin A1c [glycated hemoglobin or glycosylated hemoglobin] >=7.5%)
- Current overactive bladder defined as a score of > 8 on the Overactive Bladder Questionnaire (OAB-8) administered at the baseline visit
- History of immunosuppressive conditions or on medications which modulate the immune system
- Any significant medical history that would pose an unreasonable risk or make the participant unsuitable for the study per investigator discretion
- Participant with planned concomitant surgery
- Anterior fascial sparing radical prostatectomy
- Retzius sparing radical prostatectomy
- Participant currently participating in other investigational studies unless approved by the Sponsor in writing
- Participant is, in the investigator's judgement, part of a vulnerable population, including but not limited to:
- Prisoners
- Individuals pending incarceration
- Individuals experiencing any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affects the ability to complete the study quality of life questionnaires
- Planned adjuvant radiation therapy
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Potomac Urology Center
Alexandria, Virginia, 22311
Urology of Austin
Austin, Texas, 78759
University of Maryland
Baltimore, Maryland, 21201
John Hopkins
Baltimore, Maryland, 21287
Erlanger Urology
Chattanooga, Tennessee, 37403
University of Chicago Medicine
Chicago, Illinois, 60611
The Conrad Pearson Clinic
Germantown, Tennessee, 38138
IU school of Medicine, Department of Urology
Indianapolis, Indiana, 46202
BMHCC/ Mississippi Urology Clinic
Jackson, Mississippi, 39202
University of California Los Angeles
Los Angeles, California, 90095
Urology Associates PC Nashville
Nashville, Tennessee, 37209
Northwell Health
New Hyde Park, New York, 11042
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Mayo Clinic
Phoenix, Arizona, 85054
University of Rochester Medical Center
Rochester, New York, 14620
University of California San Diego
San Diego, California, 92093
Academic Urology
Sun City, Arizona, 85351
Tampa General Hospital
Tampa, Florida, 33606
Urology of Virginia, PLLC
Virginia Beach, Virginia, 23462
About this study
Official title: A Pivotal Study of Voro Urologic Scaffold for the Treatment of Post Prostatectomy Stress Urinary Incontinence (ARID II)
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.
- Being tested
- Voro Urologic Scaffold
- Keywords
- SUI, Radical Prostatectomy, Voro Urologic Scaffold, ARID II, Post-prostatectomy incontinence
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voro Urologic ScaffoldDevice
The Voro Urologic Scaffold is placed during the prostatectomy procedure after prostate removal.
| Study group | Role | What they receive |
|---|---|---|
| Voro Urologic Scaffold Group | Experimental | Participants will undergo robotic assisted radical prostatectomy procedure as part of their standard of care treatment for their prostate cancer. The Voro Urologic Scaffold will be placed during the prostatectomy procedure after prostate removal. Receives: Device: Voro Urologic Scaffold |
| Control Group | No intervention | Participants will undergo robotic assisted radical prostatectomy procedure as part of their standard of care treatment for their prostate cancer. This group will not receive Voro Urologic Scaffold during the treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants during the course of the study, whether or not related to the investigational device.
Measured: Upto 24 months
Number of Participants With Adverse Events Categorized by Severity
The severity of adverse events as assessed by the investigator; events will be based on the definitions outlined in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: Upto 24 months
Number of participants achieving continence as measured by 1 hour provocative pad weight test at 6 weeks post-prostatectomy
Measured: At 6 weeks post-prostatectomy
Secondary outcomes (5)
Severity of incontinence as measured by 1 hour provocative pad weight test at 6 weeks
Measured: At 6 weeks
Severity of incontinence as measured by 1 hour provocative pad weight test at 6 months
Measured: At 6 months
Quality of Life (QoL) performance as assessed by the urinary domain of Expanded Prostate Cancer Index Composite (EPIC) Questionnaire
The Expanded Prostate Cancer Index Composite is a validated, comprehensive questionnaire designed to evaluate patient function and bother after localized prostate cancer treatment. Response options for each item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better quality of life.
Measured: At 6 weeks, 6 months and 12 months
Continence rate as measured by 1-hour provocative pad weight test at 6 months post-prostatectomy
Measured: At 6 months post-prostatectomy
Number of participants achieving continence as measured by 1 hour provocative pad weight test at 12 months post-prostatectomy
Measured: At 12 months post-prostatectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start18 Apr 2025
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radical ProstatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter, single blind, randomized controlled study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Levee Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Cornett, Study director, Vice President, Levee Medical, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873581
- Sponsor's protocol ID
- 1010174
- Acronym
- ARID II
- Status last verified
- Sep 2026
- First submitted
- 7 Mar 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No