John Michael DiBianco, MD, highlights trial of stent omission after ureteroscopy

In a recent interview with Urology Times®, John Michael DiBianco, MD, outlined the design of the ongoing SOUL trial (NCT05866081), which is assessing stent omission vs stent placement following uncomplicated ureteroscopy for renal and ureteral stones.¹ The prospective trial is designed with both randomized and observational cohorts, giving patients the option to participate in the study even if they do not wish to consent to randomization.

“In the literature, upwards of one-third or two-thirds of patients will refuse randomization,” DiBianco explained. “Their data and their trajectory [are] not lost. It's still followed, and we understand what would be a patient population where we don't get that data, now we’re able to track and see how they do.”

DiBianco is an endourologist at the University of Florida in Gainesville, Florida.

In total, the study plans to enroll nearly 800 patients across 16 clinical trial sites in the US. The study is comparing both the change in pain interference from pre-surgery to days 7 to 10 as well as unplanned health care utilization across both arms.

“We're getting a lot more of the patient's perspective on stenting and sent omission, which I think is great,” DiBianco added. “I think that's an area that, in a lot of our trials, we’ve made a secondary thing.”

Final completion of the SOUL trial is expected in May 2026.

REFERENCE

1. Stent omission after ureteroscopy and lithotripsy in the Michigan Urological Surgery Improvement Collaborative. ClinicalTrials.gov. Last updated December 15, 2025. Accessed January 2, 2026. https://clinicaltrials.gov/study/NCT05866081