Pivotal Study of Voro Urologic Scaffold (ARID II)

Levee Medical

Status and phase: Enrolling; Phase 3

Conditions: Stress Urinary Incontinence (SUI); Radical Prostatectomy

Treatments: Device: Voro Urologic Scaffold

Study type: Interventional

Funder types: Industry

Identifiers

NCT06873581

1010174

Details and patient eligibility

About

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.

Enrollment: 266 estimated patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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266 participants in 2 patient groups

Voro Urologic Scaffold Group

Experimental group

Description:

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.

Treatment:

Device: Voro Urologic Scaffold

Control Group

No Intervention group

Description:

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.