Feasibility Study of a VoRo UrologIc ScaffolD (ARID)

Levee Medical

Status and phase: Active, not recruiting; Phase 2

Conditions: Stress Urinary Incontinence; Radical Prostatectomy

Treatments: Device: Voro Urologic Scaffold

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06275945

1010073

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Voro Urologic Scaffold Group

Experimental group

Description:

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.

Treatment:

Device: Voro Urologic Scaffold