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Clinical Trials in the USA / NCT06873581
Active, not recruiting Phase 3

Pivotal Study of Voro Urologic Scaffold

NCT06873581 · tracked via the Priya Life Science USA tracker
Sponsor
Levee Medical, Inc.
Phase
Phase 3
Started
2025-04-18
Last updated
2026-08-31

Condition(s) studied

Radical ProstatectomyStress Urinary Incontinence (SUI)

Investigational drug(s) / intervention(s)

Voro Urologic Scaffold

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

Study 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.

Eligibility

Sex
MALE
Min age
45 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (19)

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

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06873581 on ClinicalTrials.gov ↗ ← All trials in the USA