First patient enrolled in trial of Voro Urologic Scaffold for post-prostatectomy SUI

The first patient has been enrolled in the pivotal phase 3 ARID II trial (NCT06873581), evaluating the safety and effectiveness of the Voro Urologic Scaffold in managing post-prostatectomy stress urinary incontinence (SUI), Levee Medical announced.¹

In total, the trial plans to enroll 266 adult patients.

According to the company, the Voro Urologic Scaffold is a “bioabsorbable device designed to support the bladder neck and preserve urethral length; 2 anatomical factors associated with earlier return to continence following prostate surgery.”

The first patient in the trial was enrolled through Mississippi Baptist Medical Center. Patrick Daily, MD, a urologic surgeon at Mississippi Urology Clinic, is the site’s principal investigator.

"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,” said Daily in the news release.¹ “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.”

In total, the single-blind, randomized controlled trial plans to enroll 266 adult patients who are scheduled to undergo robotic-assisted radical prostatectomy. Participants will be enrolled through up to 30 clinical trial sites in the US.²

To be eligible for enrollment, patients need to have Gleason grade group 4 or lower disease, a prostate size less than 80 grams, and a negative urine culture within 30 days of the procedure. Those included in the study will be randomly assigned to the Voro Urologic Scaffold arm or to a control arm.

The primary outcome measures for the study are the occurrence of adverse events and the number of patients achieving continence per a 1-hour pad weight test at 6 weeks post-prostatectomy. The study will also assess quality of life and continence rates out to 6 months following the procedure.

Completion of the study is expected in February 2027.

The ARID II trial will be highlighted during a trials in progress session during the upcoming American Urological Association Annual Meeting in Las Vegas, Nevada.

Additional assessments of the device

The initiation of the ARID II study follows positive reports from the initial phase 2 ARID feasibility study (NCT06275945). In March 2025, the company reported that the feasibility study had enrolled a total of 28 patients.³

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 at up to 3 clinical trial sites in Panama.⁴ 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 announces first patient enrolled in ARID II IDE pivotal trial. News release. Levee Medical. Published online and accessed April 24, 2025. https://leveemedical.com/levee-medical-announces-first-patient-enrolled-in-arid-ii-ide-pivotal-trial/

2. Pivotal study of Voro Urologic Scaffold (ARID II). ClinicalTrials.gov. Last updated April 8, 2025. Accessed April 24, 2025. https://clinicaltrials.gov/study/NCT06873581

3. Levee Medical secures $10 million in oversubscribed series B funding. News release. February 11, 2025. Accessed April 24, 2025. https://leveemedical.com/levee-medical-secures-10-million-in-oversubscribed-series-b-funding/

4. Feasibility study of A VoRo UrologIc ScaffolD (ARID) (ARID). ClinicalTrials.gov. Updated February 23, 2024. Accessed April 24, 2025. https://clinicaltrials.gov/study/NCT06275945

5. Levee Medical to accelerate development of its Voro Urologic Scaffold, designed to improve post-prostatectomy recovery outcomes. News release. June 10, 2024. Accessed April 24, 2025. https://leveemedical.com/levee-medical-to-accelerate-development-of-its-voro-urologic-scaffold-designed-to-improve-post-prostatectomy-recovery-outcomes/

6. Data collection post radical prostatectomy (ALTO). ClinicalTrials.gov. Updated April 8, 2024. Accessed April 24, 2025. https://clinicaltrials.gov/study/NCT06351579