Pivotal Study of Voro Urologic Scaffold

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-18

Study Completion Date

2028-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Radical Prostatectomy Stress Urinary Incontinence (SUI)

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a multicenter, single blind, randomized controlled study.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Voro Urologic Scaffold

Intervention Type DEVICE

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Voro Urologic Scaffold

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

Intervention Type DEVICE

Eligibility Criteria

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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

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

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

Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen Cornett

Role: STUDY_DIRECTOR

Vice President, Levee Medical, Inc

Virginia Beach, Virginia, United States

Site Status RECRUITING

Countries

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Identifier Type: -

Identifier Source: org_study_id

Pivotal Study of Voro Urologic Scaffold

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Voro Urologic Scaffold Group

Voro Urologic Scaffold

Control Group

Interventions

Voro Urologic Scaffold

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Levee Medical, Inc.

Responsible Party

Principal Investigators

Karen Cornett

Locations

Mayo Clinic

Academic Urology

UCLA Urology

University of California San Diego

Tampa General Hospital

University of Chicago Medicine

IU school of Medicine, Department of Urology

University of Maryland

John Hopkins

Corewell Health William Beaumont University Hospital

BMHCC/ Mississippi Urology Clinic

Northwell Health

Memorial Sloan Kettering Cancer Center

University of Rochester Medical Center

Erlanger Urology

The Conrad Pearson Clinic

Urology Associates PC Nashville

Urology of Austin

Potomac Urology Center

Urology of Virginia, PLLC

Countries

Central Contacts

Karen Cornett

Facility Contacts

Jessica Gayton

Jennifer Hill

Daisy Santos

Dyhana Carrasco

Ray De La Morena

Suki Bristol

Brandon Garver

Ganine Markowitz

Michael Ayenew

Erica Zagaja

Greta Beatty

Jennie Mallory

Cynthia Knauer

Ryan Norton, MD

Austin Jackson

Angel Johnson

Russell S Grigsby

Liz Ayala

Alison Cooper

Sabrina Delfenthal

Other Identifiers

1010174