Pivotal Study of Voro Urologic Scaffold

Running, not enrolling · Phase 3

Conditions studied: Radical Prostatectomy, Stress Urinary Incontinence (SUI)

In brief

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.

Key facts

Study ID

NCT06873581

Run by

Levee Medical, Inc.

People needed

266

Starts

2025-04-18

Expected to finish

2028-04-30

Last updated by the study team

2026-07-31

Who can join

Age: 45 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 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

Where it is running

• Mayo Clinic — Phoenix, Arizona, United States
• Academic Urology — Sun City, Arizona, United States
• University of California Los Angeles — Los Angeles, California, United States
• University of California San Diego — San Diego, California, United States
• Tampa General Hospital — Tampa, Florida, United States
• University of Chicago Medicine — Chicago, Illinois, United States
• IU school of Medicine, Department of Urology — Indianapolis, Indiana, United States
• University of Maryland — Baltimore, Maryland, United States
• John Hopkins — Baltimore, Maryland, United States
• BMHCC/ Mississippi Urology Clinic — Jackson, Mississippi, United States
• Northwell Health — New Hyde Park, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Erlanger Urology — Chattanooga, Tennessee, United States
• The Conrad Pearson Clinic — Germantown, Tennessee, United States
• Urology Associates PC Nashville — Nashville, Tennessee, United States
• Urology of Austin — Austin, Texas, United States
• Potomac Urology Center — Alexandria, Virginia, United States
• Urology of Virginia, PLLC — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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