Clinical trial NCT06873581: Pivotal Study of Voro Urologic Scaffold
Official title: A Pivotal Study of Voro Urologic Scaffold for the Treatment of Post Prostatectomy Stress Urinary Incontinence (ARID II)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Radical Prostatectomy
Stress Urinary Incontinence (SUI)
Keywords: SUI
Radical Prostatectomy
Voro Urologic Scaffold
ARID II
Post-prostatectomy incontinence
Lead sponsor: Levee Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-12
Enrollment: 266
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multicenter, single blind, randomized controlled study.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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
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

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 (%) 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

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Upto 24 months
measure: Number of Participants With Adverse Events Categorized by Severity
timeFrame: Upto 24 months
measure: Number of participants achieving continence as measured by 1 hour provocative pad weight test at 6 weeks post-prostatectomy
timeFrame: At 6 weeks post-prostatectomy
Secondary outcomes:
measure: Number of participants achieving continence as measured by 1 hour provocative pad weight test at 12 months post-prostatectomy
timeFrame: At 12 months post-prostatectomy
measure: Severity of incontinence as measured by 1 hour provocative pad weight test at 6 weeks
timeFrame: At 6 weeks
measure: Severity of incontinence as measured by 1 hour provocative pad weight test at 6 months
timeFrame: At 6 months
measure: Quality of Life (QoL) performance as assessed by the urinary domain of Expanded Prostate Cancer Index Composite (EPIC) Questionnaire
timeFrame: At 6 weeks, 6 months and 12 months
measure: Continence rate as measured by 1-hour provocative pad weight test at 6 months post-prostatectomy
timeFrame: At 6 months post-prostatectomy
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU school of Medicine, Department of Urology
state: Indiana
city: Jackson
country: United States
facility: BMHCC/ Mississippi Urology Clinic
state: Mississippi
city: Austin
country: United States
facility: Urology of Austin
state: Texas
city: Virginia Beach
country: United States
facility: Urology of Virginia, PLLC
state: Virginia
Study officials:
affiliation: Vice President, Levee Medical, Inc
name: Karen Cornett
role: STUDY_DIRECTOR
References: