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Khurshid Ghani, MD, on trial of stent omission following ureteroscopy
The SOUL study is assessing patient-reported outcomes and unplanned health care utilization among patients who had stent placement vs stent omission after ureteroscopy.
At the 2025 American Urological Association (AUA) Annual Meeting, Khurshid R. Ghani, MBChB, MS, FRCS, presented a talk titled, “State-of-the-Art Lecture: Update on the SOUL Trial: To Stent or Not to Stent.” In an interview with Urology Times®, Ghani recaps this session, touching on the background, design, and current update on the trial.
Overall, the SOUL study (NCT05866081) is assessing patient-reported outcomes and unplanned health care utilization among patients who had stent placement vs patients who had stent omission following ureteroscopy for stones.
Ghani explained, “We hypothesized that patients who are stented have significantly more pain and they consume more health care utilization than folks who are not stented. There is good evidence in the literature to say that not to place a stent is safe, but there is a lack of large multi-center evidence around this. As a result of that, this study got funded by the Patient Centered Outcomes Research Institute to better assess this and provide high-quality evidence.”
Ghani is a clinical professor of urology and the program director of the Michigan Urological Surgery Improvement Collaborative (MUSIC) at the University of Michigan in Ann Arbor.
The SOUL trial is designed to include both a randomized cohort and an observational-only cohort.
In total, the study plans to enroll approximately 800 patients across 16 trial centers in the US, with 550 enrolled to date. Patients in the study need to be planned for unilateral ureteroscopy and lithotripsy for stone disease and their largest stone must be 10 mm or smaller in size.1
“I think we're at an inflection point technologically in stone disease, where the scopes are getting really small [and] the lasers are getting really good,” Ghani concluded. “I hope we're at that point in the curve where now surgeons do feel comfortable that they can do stent omission. Our goal is to unpack that evidence. I hope I can be here, back at the AUA, or my team, in 1 or 2 years, presenting the clinical results.”
REFERENCE
1. Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative. ClinicalTrials.gov. Last updated May 30, 2024. Accessed May 2, 2025. https://clinicaltrials.gov/study/NCT05866081
