John Michael DiBianco, MD, outlines rationale for the SOUL trial

John Michael DiBianco, MD, recently sat down with Urology Times® to discuss the clinical landscape that led to the initiation of the SOUL trial (NCT05866081), which is exploring the safety and feasibility of stent omission following uncomplicated ureteroscopy. Overall, he cited the inconsistencies in the guidelines as well as the lack of clear data on stenting as driving forces for the development of this study.

“We tend to stent very frequently, upwards of 90% of the time, and some urologists stent routinely after any upper tract manipulation, ureteroscopy, or laser lithotripsy,” he explained. “Part of the rationale for that is that there's not terribly good evidence one way or another as whether stenting helps, or [whether it] causes more problems for patients.”

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

DiBianco also pointed to the lack of clear guidance on stenting as a contributing factor to the hesitation among urologists to omit it following ureteroscopy.

“I think stent omission is something that a lot of urologists have a little bit of a hard time wrapping their heads around,” he added. “We're doing it for the right reasons. It's just in general, the vast majority of these are probably not necessary, and [we are] potentially causing patients discomfort, at the least, and maybe sometimes harm, at the worst.”

Thus, the prospective, multicenter trial is aiming to enroll approximately 800 patients to examine patient-reported outcomes and unplanned health care utilization between patients who have a stent placed vs patients who do not receive a stent following uncomplicated ureteroscopy.² The trial includes both randomized and observational cohorts.

REFERENCE

1. Stent omission after ureteroscopy and lithotripsy in the Michigan Urological Surgery Improvement Collaborative. ClinicalTrials.gov. Last updated December 15, 2025. Accessed December 16, 2025. https://clinicaltrials.gov/study/NCT05866081