RECRUITING

Pivotal Study of Voro Urologic Scaffold

Conditions

Radical Prostatectomy Stress Urinary Incontinence (SUI)SUI Voro Urologic Scaffold ARID II Post-prostatectomy incontinence

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-18

Study Completion:2027-02-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06873581

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 5. Negative urine cultures within 30 days of the procedure 6. Able and willing to provide written consent to participate in the study 7. Able and willing to comply with study follow-up visits and procedures 8. Willing to forego any other procedures for stress urinary incontinence (SUI) during the study	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 (%) voiding 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 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

Inclusion Criteria

Exclusion 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
5. Negative urine cultures within 30 days of the procedure
6. Able and willing to provide written consent to participate in the study
7. Able and willing to comply with study follow-up visits and procedures
8. Willing to forego any other procedures for stress urinary incontinence (SUI) during the study

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 (%) voiding 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
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

Contacts and Locations

Study Contact

Karen Cornett

CONTACT

919-313-4520

kcornett@leveemedical.com

Principal Investigator

Karen Cornett

STUDY_DIRECTOR

Vice President, Levee Medical, Inc

Study Locations (Sites)

BMHCC/ Mississippi Urology Clinic

Jackson, Mississippi, 39202

United States

Urology of Austin

Austin, Texas, 78759

United States

Collaborators and Investigators

Sponsor: Levee Medical, Inc.

Karen Cornett, STUDY_DIRECTOR, Vice President, Levee Medical, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-18

Study Completion Date2027-02-01

Study Record Updates

Study Start Date2025-04-18

Study Completion Date2027-02-01

Terms related to this study

Keywords Provided by Researchers

SUI
Radical Prostatectomy
Voro Urologic Scaffold
ARID II
Post-prostatectomy incontinence

Additional Relevant MeSH Terms

Radical Prostatectomy
Stress Urinary Incontinence (SUI)