Pivotal Study of Voro Urologic Scaffold

Launched by LEVEE MEDICAL, INC. · Mar 7, 2025

Keywords

ClinConnect Summary

This clinical trial is called the Pivotal Study of Voro Urologic Scaffold, and it aims to evaluate the safety and effectiveness of a device called the Voro Urologic Scaffold for men who are undergoing robotic-assisted radical prostatectomy. This surgery is performed to remove the prostate gland due to prostate cancer, and the study will look at how well this new device helps prevent stress urinary incontinence (which is leaking urine when you cough, laugh, or exercise) compared to standard care.

To participate in the study, men must be at least 45 years old, diagnosed with prostate cancer, and scheduled for the surgery. They should not have any other serious urinary issues or certain medical conditions that could complicate the study. The trial will include up to 266 participants across 30 locations in the U.S., and those involved can expect to have several follow-up visits after their surgery to monitor their health and the effectiveness of the device over a period of two years. It's important to know that the trial is not yet recruiting participants, so there’s still time to learn more before considering joining.

Gender

MALE

Eligibility criteria

• 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
• • 5. Negative urine cultures within 30 days of the procedure
• • 6. Able and willing to provide written consent to participate in the study
• • 7. Able and willing to comply with study follow-up visits and procedures
• • 8. 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 (%) voiding 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
• • 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