Voro Urologic Scaffold for Urinary Incontinence

(ARID II Trial)

Recruiting at 15 trial locations

Overseen By Karen Cornett

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Levee Medical, Inc.

Must not be taking: Overactive bladder medications

Disqualifiers: Urinary incontinence, Urethral stricture, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: 1 day

266 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called the Voro Urologic Scaffold, a medical device for men with prostate cancer undergoing prostate removal surgery. The main goal is to determine if this treatment helps with urinary incontinence, a common issue after prostate surgery, and to assess its safety and effectiveness compared to not using it. Participants will either receive the scaffold during their surgery or not, and the trial will compare outcomes. Men with prostate cancer who are scheduled for prostate surgery and have no history of urinary incontinence are good candidates for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on medications for overactive bladder. It's best to discuss your specific medications with the study team.

What prior data suggests that the Voro Urologic Scaffold is safe for use in men undergoing robotic assisted radical prostatectomy?

Research has shown that the Voro Urologic Scaffold is safe based on previous studies. An absorbable version of this scaffold has supported the bladder neck, and patients have noticed early improvements in bladder control. This indicates that the device is not only safe but may also aid in urinary control. Safety data from these studies indicate that the scaffold is well-tolerated, with no major side effects reported. While these results are encouraging, the current study aims to confirm these safety findings further. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for urinary incontinence?

Unlike the standard treatments for urinary incontinence after prostate surgery, which often include medications and physical therapy, the Voro Urologic Scaffold offers a novel physical support system. This scaffold is implanted during the robotic-assisted prostatectomy and provides structural support to the urethra, potentially improving urinary control right from the start. Researchers are excited because this approach addresses the issue mechanically, offering immediate benefits, unlike traditional methods that may take weeks or months to show significant improvement.

What evidence suggests that the Voro Urologic Scaffold is effective for urinary incontinence?

Research has shown that the Voro Urologic Scaffold, which participants in this trial may receive, might help reduce urine leakage in men after prostate surgery. This treatment temporarily supports the bladder neck, which controls urine flow. Early results suggest that patients who received the scaffold during surgery experienced fewer leakage problems. Some studies found that patients encountered no issues during the procedure. The scaffold is designed to dissolve over time, eventually being absorbed by the body, making it a less invasive way to manage leakage. ^{1 2 3 6 7}

Who Is on the Research Team?

Karen Cornett

Principal Investigator

Vice President, Levee Medical, Inc

Are You a Good Fit for This Trial?

Men aged 45+ diagnosed with prostate cancer, scheduled for radical prostatectomy, and willing to follow study procedures can join. They must not have severe urinary issues or other significant health problems that could interfere with the trial.

Inclusion Criteria

Able and willing to comply with study follow-up visits and procedures

Negative urine cultures within 30 days of the procedure

Able and willing to provide written consent to participate in the study

Exclusion Criteria

Participant currently participating in other investigational studies unless approved by the Sponsor in writing

Post void residual >200 milliliters (ml) or >25 percentage (%) voiding volume

Body mass index >40

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline visit to assess initial conditions before treatment

1 day

1 visit (in-person)

Treatment

Implantation of Voro Urologic Scaffold during robotic assisted radical prostatectomy

1 day

1 visit (in-person)

Initial Follow-up

Catheter removal and initial recovery monitoring

6 weeks

1 visit (in-person)

Extended Follow-up

Participants are monitored for safety and effectiveness, including quality of life assessments

24 months

Multiple visits at 6 months, 12 months, 18 months, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Voro Urologic Scaffold

Trial Overview The Voro Urologic Scaffold's safety and effectiveness are being tested in men undergoing robotic assisted radical prostatectomy compared to a control group in this randomized, controlled trial at multiple US centers.

How Is the Trial Designed?

Group I: Voro Urologic Scaffold Group Experimental Treatment 1 Intervention

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.

Group II: Control Group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Levee Medical, Inc.

Lead Sponsor

Trials

3

Recruited

340+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06873581

NCT06873581 | Pivotal Study of Voro Urologic Scaffold The objective of this study is to compare safety and effectiveness of the Voro Urologic Scaffold in adult men undergoing robotic assisted radical ...

2. urologytimes.com urologytimes.com/view/first-patient-enrolled-in-trial-of-voro-urologic-scaffold-for-post-prostatectomy-sui

First patient enrolled in trial of Voro Urologic Scaffold for ... The primary outcome measures for the study are the occurrence of adverse events and the number of patients achieving continence per a 1-hour pad ...

3. medrxiv.org medrxiv.org/content/10.1101/2025.06.29.25330348v1.full-text

Initial Results with an Absorbable Urologic Scaffold to ... An absorbable scaffold (Voro Urologic Scaffold, Levee Medical, Durham, NC) has been developed to provide radial support to the bladder neck and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11614306/

Initial Experience with an Absorbable Urologic Scaffold to ... Both patients successfully underwent the prostatectomy and urologic scaffold placement with no reported perioperative complications.

5. leveemedical.com leveemedical.com/clinical/

Clinical The Voro Scaffold provides temporary structural support to the urinary sphincter, potentially reducing incontinence and improving quality of life.

6. leveemedical.com leveemedical.com/levee-medical-secures-4-3m-strategic-investment-to-accelerate-clinical-development-of-the-voro-urologic-scaffold-designed-to-improve-robotic-prostatectomy-outcomes/

Levee Medical Secures $4.3M Strategic Investment to ... The trial will evaluate the safety and performance of the Voro Urologic Scaffold as a prophylactic treatment for post-prostatectomy stress ...

7. cms.gov cms.gov/medicare/coverage/investigational-device-exemption-ide-studies/approved/g240257-nct06873581

G240257-NCT06873581 G240257-NCT06873581 ; Study Title. A Pivotal Study of Voro Urologic Scaffold for the Treatment of Post Prostatectomy Stress Urinary Incontinence (ARID II).