Feasibility Study of a VoRo UrologIc ScaffolD (ARID)

Phase 2

Active, not recruiting

• Conditions: Radical Prostatectomy; Stress Urinary Incontinence
• Interventions: Combination Product: Voro Urologic Scaffold

• Registration Number: NCT06275945
• Lead Sponsor: Levee Medical, Inc.

Brief Summary

The objective of this study is to evaluate the safety and performance of the Voro Urologic Scaffold as a prophylactic treatment for post-prostatectomy stress urinary incontinence.

The study is a prospective, multicenter, single arm study. Up to 40 subjects will be treated at up to 3 investigational sites in Panama. Subjects will be followed up post-treatment at catheter removal, 6 weeks post prostatectomy, 3 months, 6 months, 12 months and 2 years.

Detailed Description

Approximately 300,000 men undergo radical prostatectomy (RP) worldwide for the treatment of prostate cancer. RP has favorable oncology outcomes but carries risks of erectile dysfunction and urinary incontinence. Urinary incontinence after RP has negatively affects patient quality of life.

The bioresorbable Voro Urologic Scaffold is designed to be placed over the anastomotic site during an RP procedure, between the bladder neck and urethral stump, to constrain the urethra immediately proximal to the urinary sphincter. The device is designed to relieve the load on the urinary sphincter. As the anastomosis heals, connective tissues form in the scaffold geometry while the scaffold material resorbs and hence potentially reduce the risk of acute and chronic stress incontinence.

The objective of this study is to evaluate the safety and performance of the Voro Urologic Scaffold as a prophylactic treatment for post-prostatectomy stress urinary incontinence.

The study is a prospective, multicenter, single arm study. Up to 40 subjects will be treated at up to 3 investigational sites in Panama. Subjects will be followed up post-treatment at catheter removal, 6 weeks post prostatectomy, 3 months, 6 months, 12 months and 2 years.

Study Timeline

• Study Start: 2023-04-03
• Study First Submitted: 2024-02-08
• Study First Submitted QC: 2024-02-16
• Study First Posted: 2024-02-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-06
• Primary Completion: 2026-07-30
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

1. Male 45-70 years of age
2. Diagnosed with prostate cancer and scheduled for radical prostatectomy
3. Gleason Grade Group 3 or lower
4. Prostate size less than 80 grams
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

Exclusion Criteria

1. Malignant tumors outside of the prostate capsule confirmed via baseline assessments (e.g., mpMRI, bone scan)
2. History of urinary incontinence, including stress or urge urinary incontinence
3. On medications to treat overactive bladder (OAB)
4. Post void residual >200 ml or > 25% voiding volume
5. Presence of urethral stricture or bladder neck contracture
6. Current or chronic urinary tract infection
7. Prior urologic outlet surgical or minimally invasive procedure (e.g., TURP, HoLEP, Rezum, etc.).
8. Prior pelvic radiation or anticipated need for radiation after radical prostatectomy
9. Presence of stones in the bladder
10. History of neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function
11. Body mass index >35
12. Insulin-dependent diabetes mellitus
13. Current uncontrolled diabetes (i.e., hemoglobin A1c ≥7.5%)
14. Intravesical prostatic protrusion (IPP) >5mm
15. History of immunosuppressive conditions (e.g., AIDS, post-transplant)
16. Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study per investigator discretion
17. Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affect the ability to complete the study quality of life questionnaires
18. Subject currently participating in other investigational studies unless approved by the Sponsor in writing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Voro Urologic Scaffold Group	Voro Urologic Scaffold	Subjects undergo radical prostatectomy procedure as part of their stand of care treatment for their prostate cancer. The Voro Urologic Scaffold is placed during the prostatectomy procedure after prostate removal. The device is placed over the urethral stump in its compressed configuration. With the device compressed at the pelvic floor, the urethral stump is anastomosed with the bladder neck. The device is expanded and positioned over the anastomosed urethra and bladder neck. The distal end of the device is sutured in place and the proximal end of the device is sutured to the bladder. The time of Voro Urologic Scaffold insertion and time of completion of device placement (i.e., final sutures placed) will be recorded. Incision closure will proceed per institution standard of care for the radical prostatectomy procedure.

Primary Outcome Measures

Name	Time	Method
The change in pad weight of 24-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups.	Baseline, Foley removal (about 2-week post procedure), 6-week, and 3-, 6-, 12- & 24-months follow-ups.	The pads are pre-weighed prior to providing them to subjects. The test should be started with an empty bladder. The subject will wear pads and perform their normal daily activities for 24 hours.

Secondary Outcome Measures

Name	Time	Method
The change in pad weight of 1-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups.	Baseline, post-procedure 6-week, and 3-, 6-, 12- & 24-months follow-ups.	The 1-hour pad test follows a standard protocol. Prior to the 1-hour test, the subject is asked to ensure he is adequately hydrated. This will be determined by the color of the urine during the voiding prior to the start of the test. The urine must be clear or light yellow in color to start the test. If the urine is dark yellow, the subject should be given fluids to drink until the urine is light yellow or close to colorless (proper hydration).; If voiding is urgent and unavoidable, the test is terminated. Collect voiding volume and repeat the test after re-hydration.
The changes in the standing cough test (SCT) from baseline to post procedure 6-month and 12-month follow-ups.	Baseline, post-procedure 6-week, and 3-, 6-, 12- & 24-months follow-ups.	The subject must verbally confirm that they have not voided for at least 60 minutes prior to the examination. Examination of the urethral meatus is performed while the subject performs four forceful coughs. Towels or pads are held several inches from the meatus during coughs to collect any urinary leakage. Leakage is evaluated using the Male Stress Incontinence Grading Scale (MSIGS).

Trial Locations

Locations (1)

National Hospital; 🇵🇦 Panama City, Punta Pacifica, Panama