Pivotal Study of Voro Urologic Scaffold (ARID II)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Radical Prostatectomy; Stress Urinary Incontinence (SUI)
• Intervention / Treatment: Device: Voro Urologic Scaffold

• Study Type: Interventional
• Enrollment (Estimated): 266
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic
    • Sun City, Arizona, United States, 85351
      • Academic Urology
  • California
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles
    • San Diego, California, United States, 92093
      • University of California San Diego
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • University of Chicago Medicine
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • IU school of Medicine, Department of Urology
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
    • Baltimore, Maryland, United States, 21287
      • John Hopkins
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • BMHCC/ Mississippi Urology Clinic
  • New York
    • New Hyde Park, New York, United States, 11042
      • Northwell Health
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • Rochester, New York, United States, 14620
      • University of Rochester Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Urology
    • Germantown, Tennessee, United States, 38138
      • The Conrad Pearson Clinic
    • Nashville, Tennessee, United States, 37209
      • Urology Associates PC Nashville
  • Texas
    • Austin, Texas, United States, 78759
      • Urology of Austin
  • Virginia
    • Alexandria, Virginia, United States, 22311
      • Potomac Urology Center
    • Virginia Beach, Virginia, United States, 23462
      • Urology of Virginia, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male >= 45 years of age of any race and ethnic group
2. Diagnosed with prostate cancer and scheduled for radical prostatectomy
3. Gleason Grade Group 4 or lower
4. Prostate size less than 80 grams, as measured by Magnetic Resonance Imaging (MRI)
5. Able and willing to provide written consent to participate in the study
6. Able and willing to comply with study follow-up visits and procedures
7. Willing to forego any other procedures for stress urinary incontinence (SUI) during the study

Exclusion Criteria:

1. 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)
2. History of urinary incontinence, including stress or urge urinary incontinence
3. Demonstration of SUI, such as positive 1 hour pad weight test or participant reported incontinence episodes
4. Currently treated with medications to treat overactive bladder (OAB)
5. Post void residual >200 milliliter (ml) or > 25 percentage (%) total volume(= voided volume + residual volume)
6. Presence of urethral stricture or bladder neck contracture
7. History of urethral stricture
8. Current or chronic urinary tract infection
9. 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.).
10. Prior pelvic radiation or anticipated need for radiation after radical prostatectomy
11. History of neurogenic lower urinary tract dysfunction
12. History or current need for intermittent urinary catheterization
13. Body mass index >40
14. 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)
15. History of bladder malignancy
16. Diagnosed or suspected primary neurologic conditions known to affect voiding function
17. History of clinically significant congestive heart failure (i.e., New York Heart Association [NYHA] Class III and IV)
18. Current uncontrolled diabetes (i.e., hemoglobin A1c [glycated hemoglobin or glycosylated hemoglobin] >=7.5%)
19. Current overactive bladder defined as a score of > 8 on the Overactive Bladder Questionnaire (OAB-8) administered at the baseline visit
20. History of immunosuppressive conditions or on medications which modulate the immune system
21. Any significant medical history that would pose an unreasonable risk or make the participant unsuitable for the study per investigator discretion
22. Participant with planned concomitant surgery
23. Anterior fascial sparing radical prostatectomy
24. Retzius sparing radical prostatectomy
25. Participant currently participating in other investigational studies unless approved by the Sponsor in writing

26. Participant is, in the investigator's judgement, part of a vulnerable population, including but not limited to:

    1. Prisoners
    2. Individuals pending incarceration
    3. 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
27. Planned adjuvant radiation therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Voro Urologic Scaffold Group; 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.	Device: Voro Urologic Scaffold; The Voro Urologic Scaffold is placed during the prostatectomy procedure after prostate removal.
No Intervention: Control Group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Upto 24 months
Number of participants achieving continence as measured by 1 hour provocative pad weight test at 6 weeks post-prostatectomy		At 6 weeks post-prostatectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants achieving continence as measured by 1 hour provocative pad weight test at 12 months post-prostatectomy		At 12 months post-prostatectomy
Severity of incontinence as measured by 1 hour provocative pad weight test at 6 weeks		At 6 weeks
Severity of incontinence as measured by 1 hour provocative pad weight test at 6 months		At 6 months
Continence rate as measured by 1-hour provocative pad weight test at 6 months post-prostatectomy		At 6 months post-prostatectomy
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.	At 6 weeks, 6 months and 12 months

Collaborators and Investigators

• Sponsor: Levee Medical, Inc.
• Investigators: Study Director: Karen Cornett, Vice President, Levee Medical, Inc

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: March 7, 2025
• First Submitted That Met QC Criteria: March 7, 2025
• First Posted (Actual): March 12, 2025

Study Record Updates

• Last Update Posted (Actual): August 31, 2026
• Last Update Submitted That Met QC Criteria: August 28, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: SUI; Radical Prostatectomy; Post-prostatectomy incontinence; Voro Urologic Scaffold; ARID II
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence, Stress
• Other Study ID Numbers: 1010174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No