Voro Urologic Scaffold for Urinary Incontinence

(ARID II Trial)

Recruiting at 3 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

Trial Summary

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 data supports the effectiveness of the Voro Urologic Scaffold treatment for urinary incontinence?

The research on bioengineered scaffolds for urethra reconstruction suggests that combining cells, bioactive molecules, and biomaterials can offer promising treatment options for urinary issues. This indicates that similar scaffold systems, like the Voro Urologic Scaffold, might be effective for urinary incontinence. ^{1 2 3 4 5}

How does the Voro Urologic Scaffold treatment for urinary incontinence differ from other treatments?

The Voro Urologic Scaffold is unique because it likely focuses on providing long-term support and tissue integration, unlike many existing injectable biomaterials that degrade quickly and lack tissue regeneration properties. This approach aims to offer a more durable solution for urinary incontinence by enhancing tissue regeneration and establishing permanent support. ^{6 7 8 9 10}

What is the purpose of this trial?

The objective of this study is to compare safety and effectiveness of the Voro Urologic Scaffold in adult men undergoing robotic assisted radical prostatectomy as compared to control arm. The study is a multi-center, single blind, randomized, controlled trial. Up to 266 participants will be treated at up to 30 centers in the United States. The study will consist of a Baseline visit, implantation during robotic assisted radical prostatectomy (RARP), catheter removal, 6 weeks, 6 months, 12 months, 18 months, and 24 months.

Research Team

Karen Cornett

Principal Investigator

Vice President, Levee Medical, Inc

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Artificial urinary Sphincter 800. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Bioengineered Scaffolds as Substitutes for Grafts for Urethra Reconstruction. [2020]

3. Spain pubmed.ncbi.nlm.nih.gov

[Artificial sphincter in severe urinary incontinence: 9 years of experience]. [2006]

4. Spain pubmed.ncbi.nlm.nih.gov

[Electric stimulation of sacral roots for the treatment of urinary incontinence due to detrusor instability: application of a technique and results in a clinical case]. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

The UroLume endoprosthesis: a summary of the European and North American experience. [2006]

6. United States pubmed.ncbi.nlm.nih.gov

Injectable biomaterials for incontinence and vesico-ureteral reflux: current status and future promise. [2020]

7. France pubmed.ncbi.nlm.nih.gov

[Transobturator urethral suspension: mini-invasive procedure in the treatment of stress urinary incontinence in women]. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Injectable biomaterials for the treatment of stress urinary incontinence: their potential and pitfalls as urethral bulking agents. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Treatment of stress incontinence by a fibrin bioplast. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Advancements in minimally invasive treatments for female stress urinary incontinence: radiofrequency and bulking agents. [2022]