Pivotal Study of Voro Urologic Scaffold

Phase 3

Recruiting

• Conditions: Radical Prostatectomy; Stress Urinary Incontinence (SUI)

• Registration Number: NCT06873581
• Lead Sponsor: Levee Medical, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-03-07
• Study First Posted: 2025-03-12
• Study Start: 2025-04-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-02
• Primary Completion: 2027-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 266

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events (AEs)	Upto 24 months	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.
Number of Participants With Adverse Events Categorized by Severity	Upto 24 months	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.
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 Outcome Measures

Name	Time	Method
Number of participants achieving continence as measured by 1 hour provocative pad weight test at 12 months post-prostatectomy	At 12 months post-prostatectomy
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	The Expanded Prostate Cancer Index Composite is a validated, comprehensive questionnaire designed to evaluate patient function and bother after localized prostate cancer treatment. Response options for each item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better quality of life.
Continence rate as measured by 1-hour provocative pad weight test at 6 months post-prostatectomy	At 6 months post-prostatectomy

Trial Locations

Locations (2)

BMHCC/ Mississippi Urology Clinic; 🇺🇸 Jackson, Mississippi, United States

Urology of Austin; 🇺🇸 Austin, Texas, United States