Feasibility Study of A VoRo UrologIc ScaffolD (ARID)

NCT ID: NCT06275945

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-03
• Study Completion Date: 2026-10-30

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.

Conditions

Stress Urinary Incontinence; Radical Prostatectomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Voro Urologic Scaffold Group

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.

Group Type: EXPERIMENTAL

Voro Urologic Scaffold

Intervention Type: DEVICE

radical prostatectomy

Interventions

Voro Urologic Scaffold

radical prostatectomy

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

RQM+

INDUSTRY

Sponsor Role: collaborator

Levee Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruce Choi

Role: STUDY_CHAIR

Founder and CTO, Levee Medical, Inc

Locations

National Hospital

Panama City, Punta Pacifica, Panama

Countries

Panama

Other Identifiers

1010073

Identifier Type: -

Identifier Source: org_study_id