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Comparing Voro Urologic Scaffold for men after prostate surgery

A Pivotal Study of Voro Urologic Scaffold for the Treatment of Post Prostatectomy Stress Urinary Incontinence (ARID II)

PHASE3 · Levee Medical, Inc. · NCT06873581

This study is testing if the Voro Urologic Scaffold can help men who have had prostate surgery by reducing urinary incontinence.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment266 (estimated)
Ages45 Years and up
SexMale
SponsorLevee Medical, Inc. (industry)
Drugs / interventionsradiation
Locations19 sites (Phoenix, Arizona and 18 other locations)
Trial IDNCT06873581 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the Voro Urologic Scaffold in adult men undergoing robotic-assisted radical prostatectomy. It is a multi-center, single-blind, randomized, controlled trial involving up to 266 participants across 30 centers in the United States. Participants will undergo implantation of the scaffold during surgery, followed by follow-up visits at various intervals to assess outcomes related to urinary incontinence.

Who should consider this trial

Good fit: Ideal candidates are men aged 45 and older, diagnosed with prostate cancer, and scheduled for radical prostatectomy.

Not a fit: Patients with a history of urinary incontinence or those with malignant tumors invading the bladder neck or urethral sphincter may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option to reduce urinary incontinence after prostate surgery.

How similar studies have performed: Other studies have explored similar interventions for post-prostatectomy incontinence, but the specific use of the Voro Urologic Scaffold is a novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Phoenix, Arizona and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Radical Prostatectomy, Stress Urinary Incontinence, SUI, Voro Urologic Scaffold, ARID II, Post-prostatectomy incontinence

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.