First Patient Enrolled in ARID II Trial for Post-Prostatectomy Incontinence
Levee Medical has begun its pivotal ARID II trial, studying the Voro Scaffold for improved continence after prostatectomy.
PC-3 human prostate cancer cells: © heitipaves - stock.adobe.com
The first patient has been enrolled in the pivotal ARID II (A Pivotal Study of VoRo UrologIc ScaffolD for the Treatment of Post Prostatectomy Stress Urinary Incontinence) trial that is looking to evaluate safety and efficacy of the Voro® Urologic Scaffold in adult male patients undergoing robotic-assisted radical prostatectomy.1
In the multicenter, single-blind, randomized, controlled study, investigators aim to better the treatment of post-prostatectomy stress urinary incontinence with the Voro® Urologic Scaffold. In March 2025, the FDA granted approval to initiate the ARID II trial.2
This first patient in the ARID II pivotal trial was enrolled at Mississippi Baptist Medical Center where Patrick Daily, MD, of Mississippi Urology Clinic, serves as the principal investigator.1
"What is truly exciting is the potential for this device to meaningfully improve early and long-term continence rates, which can profoundly impact a patient's recovery and overall quality of life. We're excited to be the first site to enroll in the study and I look forward to seeing the outcomes once the study is complete," Daily said in the press release.
The Voro® Urologic Scaffold is a novel, bioabsorbable implant engineered to provide structural support to the bladder neck and maintain urethral length—2 anatomical elements linked to improved early recovery of urinary continence following radical prostatectomy.1 This device represents the lead investigational product in development by Levee Medical.
The Voro® Scaffold is currently limited to investigational use and has not received regulatory approval for commercial distribution in the United States or internationally.
Initiation of ARID II follows positive reports from the initial phase 2 ARID study (NCT06275945), a feasibility trial which enrolled 28 patients treated at investigational sites in Panama.3,4 Once enrolled, patients were followed up post treatment at catheter removal, 6 weeks post prostatectomy, 3 months, 6 months, 12 months, and 2 years.4
ARID II plans to enroll 40 adult patients. Enrollment is open to patients aged 45 to 70 years of age with a Gleason grade group 3 or lower prostate cancer and a prostate size less than 80 grams.
The primary end point of the study is the change in pad weight on a 24-hour pad weight test from baseline to 6 months and 12 months following radical prostatectomy. Change in pad weight on a 1-hour pad weight test and the change in standing cough test from baseline to 6 months and 12 months following surgery serves as the secondary end points.
"Initiating the ARID II trial marks an important step as we build upon the promising results of our initial feasibility study," said Bruce Choi, founder, director, chief technology officer, and chairman of Levee Medical, in the press release.1 "This next phase brings us closer to providing a new standard of care for men recovering from prostate cancer surgery."
