Initial ARID results published in World Journal of Urology as pivotal trial progresses

Interim data from the ARID trial (NCT06275945) have been published in the World Journal of Urology, showing promising outcomes with the Voro Urologic Scaffold in minimizing stress urinary incontinence (SUI) following robot-assisted radical prostatectomy (RARP).^1,2

According to the authors, the implantable, absorbable urologic scaffold is designed to “elongate the urethra and provide radial support to the bladder neck and urethral stump” at the time of surgery. The device is also under assessment in the pivotal ARID II trial (NCT06873581), which has reached its halfway enrollment milestone, Levee Medical announced.

"This recent publication in the World Journal of Urology marks a key step in the dissemination of data showing that a novel urologic scaffold at the time of prostatectomy can enhance continence recovery," said Jeffrey Gahan, MD, BSc, of Duke University in Raleigh, North Carolina, in a news release on the publication.² "The data were generated using one of the most rigorous definitions of continence to date, strengthening the publication's conclusions and informing the design of the ongoing randomized trial."

In total, the study enrolled 24 patients who underwent placement of the urologic scaffold during RARP. The mean age of participants was62.9 ± 7.4 years. Although the trial was not sufficiently powered, the primary end points were device safety and continence rate across different follow-up time points up to 6 months.

The authors noted, “Continence was rigorously defined as return to pre-surgery pad weight, inclusive of measurement error, using 24-hour pad weight testing.”

Overall, 29.2% of patients experienced an adverse event (AEs), but none were deemed to be related to the study device. All procedure-related AEs were consistent with what is expected with radical prostatectomy.

Upon catheter removal, 50% of patients were continent per 24-hour pad weight test. This rate improved to 52.2% at 6 weeks, 57.1% at 3 months, and 76.2% at 6 months.

The investigators also conducted a sub-analysis to account for sub-optimally placed devices upon video review. Continence was notably higher among patients with correctly placed/fully extended devices, with rates of 80.0% at 6 weeks and 92.9% at 6 months per 24-hour pad weight test. Among those with sub-optimally placed/minimally extended devices, continence rates were 0% at 6 weeks and 42.9% at 6 months.

The positive relationship between device extension and continence outcomes was maintained when assessing 1-hour pad weight tests. At 6 weeks, 87.5% of patients with fully extended devices were continent vs 0% of patients with minimally extended devices. At both 3 and 6 months, continence rates were 78.6% among those with fully extended devices vs 14.3% among those with minimally extended devices.

The current analysis was limited by a non-randomized trial design and small sample size. These limitations will be addressed in the ongoing ARID II trial, which is currently enrolling participants.

ARID II is a prospective, multicenter, randomized controlled trial of the Voro Urologic Scaffold in patients undergoing RARP. Participants in the trial will be followed for up to 2 years. The authors noted, “This study is also incorporating a standardized training program for surgeons placing the device in order to reduce the incidence of improper device placement.”

"It's encouraging to see ARID II enrolling so efficiently—our collective focus remains on exploring this exciting approach that may improve recovery for men after prostate cancer surgery," said Lee Richstone, MD, FACS, FRCS, chair of Northwell Urology at Lenox Hill Hospital, in the news release from the company.² "Expediting continence following surgery matters to my patients and is a truly important goal."

The ARID II trial is expected to reach final completion in February 2028.³

REFERENCES
1. Gahan JC, Espino G, Young M, Bodden E, Ferrandino MN. Initial results with an absorbable urologic scaffold to mitigate early urinary incontinence following radical prostatectomy: the ARID study. World J Urol. 2026;44(1):106. doi:10.1007/s00345-026-06186-7

2. Levee Medical® announces landmark ARID II trial nears halfway enrollment milestone and publication of ARID clinical results in World Journal of Urology. News release. Levee Medical. January 20, 2026. Accessed January 20, 2026. https://www.prnewswire.com/news-releases/levee-medical-announces-landmark-arid-ii-trial-nears-halfway-enrollment-milestone-and-publication-of-arid-clinical-results-in-world-journal-of-urology-302664849.html

3. Pivotal Study of Voro Urologic Scaffold (ARID II). ClinicalTrials.gov. Last updated December 23, 2025. Accessed January 20, 2026. https://clinicaltrials.gov/study/NCT06873581