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
You may not be if
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
Clareo Health | Pivotal Study of Voro Urologic Scaffold
