FDA greenlights pivotal trial of Voro Urologic Scaffold for postprostatectomy SUI

The FDA has granted clearance to an investigational device exemption application to initiate the pivotal ARID II trial of the Voro Urologic Scaffold for postprostatectomy stress urinary incontinence (SUI), Levee Medical announced in a news release.¹

The ARID II study follows positive reports from a phase 2 feasibility study.

"Incontinence is a common, yet often under-addressed consequence of prostate cancer surgery," said principal investigator Arvin K. George, MD, director of Prostate Cancer Programs at Johns Hopkins University School of Medicine in Baltimore, Maryland, in the news release.¹ "The Voro Urologic Scaffold represents a promising new approach that could redefine how we manage postsurgical incontinence, potentially enhancing the quality of life for many patients."

Overall, the multicenter study is assessing the safety and effectiveness of the device in men who are scheduled to undergo robotic-assisted radical prostatectomy. Participants will be randomly assigned to the Voro Urologic Scaffold arm or to a control arm.

According to the company, the device is “designed to be placed during the prostatectomy procedure to manage the geometry of the bladder neck and maintain urethral length, which are critical factors in preventing postoperative incontinence.”²

Additional assessments of the device

The initiation of the ARID II study follows positive reports from the initial phase 2 ARID feasibility study (NCT06275945). Last month, the company reported that the feasibility study had enrolled a total of 28 patients.²

The study’s principal investigator, Gustavo Espino, MD, of Hospital Nacional in Panama City, commented in the news release, “Our experience with the Voro Urologic Scaffold has been extremely encouraging. The device had an outstanding safety profile, and patients have noted early improvements in continence, which translates to a considerably better quality of life post-surgery.”

In total, the prospective feasibility study aims to enroll 40 adult patients across 3 clinical trial sites in Panama.³ To be eligible for enrollment, patients must be 45 to 70 years of age and have Gleason grade group 3 or lower prostate cancer and a prostate size less than 80 grams.

The primary outcome measure for 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. Secondary outcomes include the 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.

The completion of the feasibility study is expected in October 2026.

The Voro Urologic Scaffold is also being assessed in the observational ALTO study (NCT06351579), which is evaluating urinary function and quality of life among patients who underwent radical prostatectomy. The first patient was enrolled in the study in June 2024.⁴

Completion of that study is expected in March 2026.⁵

REFERENCES
1. Levee Medical receives FDA approval for its landmark ARID II IDE pivotal study. News release. Levee Medical. March 4, 2025. Accessed March 4, 2025. https://www.prnewswire.com/news-releases/levee-medical-receives-fda-approval-for-its-landmark-arid-ii-ide-pivotal-study-302389471.html

2. Levee Medical secures $10 million in oversubscribed series B funding. News release. February 11, 2025. Accessed March 4, 2025. https://leveemedical.com/levee-medical-secures-10-million-in-oversubscribed-series-b-funding/

3. Feasibility study of A VoRo UrologIc ScaffolD (ARID) (ARID). ClinicalTrials.gov. Updated February 23, 2024. Accessed March 4, 2025. https://clinicaltrials.gov/study/NCT06275945

4. Levee Medical to accelerate development of its Voro Urologic Scaffold, designed to improve post-prostatectomy recovery outcomes. News release. June 10, 2024. Accessed March 4, 2025. https://leveemedical.com/levee-medical-to-accelerate-development-of-its-voro-urologic-scaffold-designed-to-improve-post-prostatectomy-recovery-outcomes/

5. Data collection post radical prostatectomy (ALTO). ClinicalTrials.gov. Updated April 8, 2024. Accessed March 4, 2025. https://clinicaltrials.gov/study/NCT06351579