Pivotal Study of Voro Urologic Scaffold

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) duringthe study

Exclusion Criteria:

1. Malignant tumors with known bladder neck or urethral sphincter invasion ormetastatic 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 participantreported incontinence episodes

4. Currently treated with medications to treat overactive bladder (OAB)

5. Post void residual >200 milliliter (ml) or > 25 percentage (%) total volume(= voidedvolume + 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., Transurethralresection 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) whichis not considered in complete 5 year remission (excluding squamous and basal cellskin carcinoma)

15. History of bladder malignancy

16. Diagnosed or suspected primary neurologic conditions known to affect voidingfunction

17. History of clinically significant congestive heart failure (i.e., New York HeartAssociation [NYHA] Class III and IV)

18. Current uncontrolled diabetes (i.e., hemoglobin A1c [glycated hemoglobin orglycosylated hemoglobin] >=7.5%)

19. Current overactive bladder defined as a score of > 8 on the Overactive BladderQuestionnaire (OAB-8) administered at the baseline visit

20. History of immunosuppressive conditions or on medications which modulate the immunesystem

21. Any significant medical history that would pose an unreasonable risk or make theparticipant 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 approvedby the Sponsor in writing

26. Participant is, in the investigator's judgement, part of a vulnerable population,including but not limited to:

27. Prisoners

28. Individuals pending incarceration

29. Individuals experiencing any cognitive or psychiatric condition that interfereswith or precludes direct and accurate communication with the study investigatorregarding the study or affects the ability to complete the study quality oflife questionnaires

30. Planned adjuvant radiation therapy