NCT06873581

Pivotal Study of Voro Urologic Scaffold

A Pivotal Study of Voro Urologic Scaffold for the Treatment of Post Prostatectomy Stress Urinary Incontinence (ARID II)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 266 (estimated)
• Sponsor: Levee Medical, Inc. · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Radical Prostatectomy
• Stress Urinary Incontinence (SUI)

Interventions

Type	Name	Description
DEVICE	Voro Urologic Scaffold	The Voro Urologic Scaffold is placed during the prostatectomy procedure after prostate removal.

Timeline

• Start date: 2025-04-18
• Primary completion: 2027-02-01
• Completion: 2028-02-01
• First posted: 2025-03-12
• Last updated: 2026-03-30

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated device study