Pivotal Study of Voro Urologic Scaffold

NCT06873581 | Recruiting Phase 3 FDA Device

• 1 other identifier: 1010174
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 19

Brief 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. 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

Radical Prostatectomy; Stress Urinary Incontinence (SUI)

Keywords

SUI; Radical Prostatectomy; Voro Urologic Scaffold; ARID II; Post-prostatectomy incontinence

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

• Quality of Life (QoL) performance as assessed by the urinary domain of Expanded Prostate Cancer Index Composite (EPIC) Questionnaire

  At 6 weeks, 6 months and 12 months

• Continence rate as measured by 1-hour provocative pad weight test at 6 months post-prostatectomy

  At 6 months post-prostatectomy

• Number of participants achieving continence as measured by 1 hour provocative pad weight test at 12 months post-prostatectomy

  At 12 months post-prostatectomy

Study Arms (2)

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.

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.

Interventions

Voro Urologic Scaffold DEVICE

The Voro Urologic Scaffold is placed during the prostatectomy procedure after prostate removal.

Voro Urologic Scaffold Group

Eligibility Criteria

• Age: 45 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 bladder malignancy
• Diagnosed or suspected primary neurologic conditions known to affect voiding function

Sponsors & Collaborators

• Levee Medical, Inc.: lead

Study Sites (19)

Mayo Clinic

Phoenix, Arizona, 85054, United States

RECRUITING

Academic Urology

Sun City, Arizona, 85351, United States

RECRUITING

University of California Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

University of California San Diego

San Diego, California, 92093, United States

RECRUITING

Tampa General Hospital

Tampa, Florida, 33606, United States

RECRUITING

University of Chicago Medicine

Chicago, Illinois, 60611, United States

RECRUITING

IU school of Medicine, Department of Urology

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

John Hopkins

Baltimore, Maryland, 21287, United States

RECRUITING

BMHCC/ Mississippi Urology Clinic

Jackson, Mississippi, 39202, United States

RECRUITING

Northwell Health

New Hyde Park, New York, 11042, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

University of Rochester Medical Center

Rochester, New York, 14620, United States

RECRUITING

Erlanger Urology

Chattanooga, Tennessee, 37403, United States

RECRUITING

The Conrad Pearson Clinic

Germantown, Tennessee, 38138, United States

RECRUITING

Urology Associates PC Nashville

Nashville, Tennessee, 37209, United States

RECRUITING

Urology of Austin

Austin, Texas, 78759, United States

RECRUITING

Potomac Urology Center

Alexandria, Virginia, 22311, United States

RECRUITING

Urology of Virginia, PLLC

Virginia Beach, Virginia, 23462, United States

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen Cornett

  Vice President, Levee Medical, Inc

  STUDY DIRECTOR

Central Study Contacts

Karen Cornett

CONTACT

919-313-4520; kcornett@leveemedical.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a multicenter, single blind, randomized controlled study.

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 12, 2025
• Study Start: April 18, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)