Pivotal Study of Voro Urologic Scaffold

Inclusion Criteria23

• Male \>= 45 years of age of any race and ethnic group
• Diagnosed with prostate cancer and scheduled for radical prostatectomy
• Gleason Grade Group 4 or lower
• Prostate size less than 80 grams, as measured by Magnetic Resonance Imaging (MRI)
• Able and willing to provide written consent to participate in the study
• Able and willing to comply with study follow-up visits and procedures
• Willing to forego any other procedures for stress urinary incontinence (SUI) during the study
• History of bladder malignancy
• Diagnosed or suspected primary neurologic conditions known to affect voiding function
• History of clinically significant congestive heart failure (i.e., New York Heart Association \[NYHA\] Class III and IV)
• Current uncontrolled diabetes (i.e., hemoglobin A1c \[glycated hemoglobin or glycosylated hemoglobin\] \>=7.5%)
• Current overactive bladder defined as a score of \> 8 on the Overactive Bladder Questionnaire (OAB-8) administered at the baseline visit
• History of immunosuppressive conditions or on medications which modulate the immune system
• Any significant medical history that would pose an unreasonable risk or make the participant unsuitable for the study per investigator discretion
• Participant with planned concomitant surgery
• Anterior fascial sparing radical prostatectomy
• Retzius sparing radical prostatectomy
• Participant currently participating in other investigational studies unless approved by the Sponsor in writing
• Participant is, in the investigator's judgement, part of a vulnerable population, including but not limited to:
• Prisoners
• Individuals pending incarceration
• 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
• Planned adjuvant radiation therapy