A Pivotal Study of Voro Urologic Scaffold for the Treatment of Post Prostatectomy Stress Urinary Incontinence (ARID II)
Levee Medical, Inc.
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.
Eligibility
- Age range
- 45+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Male \>= 45 years of age of any race and ethnic group 2. Diagnosed with prostate cancer and scheduled for radical prostatectomy 3. Gleason Grade Group 4 or lower 4. Prostate size less than 80 grams, as measured by Magnetic Resonance Imaging (MRI) 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 7. Willing to forego any other procedures for stress urinary incontinence (SUI) during the study Exclusion Criteria: 1. Malignant tumors with known bladder neck or urethral sphinc…
Interventions
- DeviceVoro Urologic Scaffold
The Voro Urologic Scaffold is placed during the prostatectomy procedure after prostate removal.
Locations (19)
- Mayo ClinicPhoenix, Arizona
- Academic UrologySun City, Arizona
- University of California Los AngelesLos Angeles, California
- University of California San DiegoSan Diego, California
- Tampa General HospitalTampa, Florida
- University of Chicago MedicineChicago, Illinois