NCT06275945

Feasibility Study of A VoRo UrologIc ScaffolD (ARID)

Feasibility Study of A VoRo UrologIc ScaffolD for the Prophylactic Treatment of Post-Prostatectomy Stress Urinary Incontinence

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Levee Medical, Inc. · Industry
• Sex: Male
• Age: 45 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Voro Urologic Scaffold	radical prostatectomy

Timeline

• Start date: 2023-04-03
• Primary completion: 2026-07-30
• Completion: 2026-10-30
• First posted: 2024-02-23
• Last updated: 2025-03-06

Locations

1 site across 1 country: Panama