SOUL Trial reveals clear patient preference: Skip the stent after ureteroscopy
Stent omission reduces pain and health care utilization post-surgery.
Whether or not to insert a stent following ureteroscopic stone removal is a familiar debate. Initial results on patient preferences from the Stent Omission after Ureteroscopy and Lithotripsy (SOUL) trial show that patients want stents omitted—and if a stent is placed, they want better information on stent removal.
“We know that many patients undergoing ureteroscopy do not want a stent placed,” said Khurshid Ghani, MBChB, MS, FRCS, professor of urology and program director of Michigan Urological Surgery Improvement Collaborative (MUSIC), University of Michigan Medical School. “As a patient who underwent stent omission wrote, ‘No stent equals no vomiting equals no disability for seven days.’ We are in the field to do good for our patients and nothing makes us happier than when we hear how delighted, how happy, our patients are.”
Dr. Ghani outlined the patient preference outcomes for the first 541 of a planned 800 patients during a state-of-the-art lecture during the Sunday morning Plenary. The trial of stenting vs. no stenting following ureteroscopic lithotripsy grew out of years of conflicting trial reports and recent data showing wide variation in stenting practices among urologic surgeons.
“In Michigan, we found that stents are placed around 73% of the time,” Dr. Ghani reported. “What’s important is the variation. There are 140 urologists in Michigan performing urethroscopy. Regardless of the volume, stenting is variable. There are some surgeons who stent at 10% to 20% and others at 80%, 90% and 100% routinely.”
Guidelines from the AUA and the European Association of Urology both discourage the use of stents in uncomplicated cases. MUSIC reported stent placement increased emergency department visits statewide, largely due to pain. Patients who are stented report higher pain levels, which lead to increased health care utilization. European data show that up to half of stented patients miss work, especially while the stent is in place.
Multiple literature reviews on stenting have come to opposing conclusions. A Cochrane review in 2019 found that while not stenting may reduce the number of unplanned healthcare visits, the evidence is uncertain and larger, high-quality trials are needed.
SOUL is randomizing patients to stent vs. no-stent in the OR after ureteroscopy is completed. About 38% of eligible patients have accepted randomization and are included in an intent-to-treat analysis. Patients who did not accept randomization are being followed in an observational study.
The co-primary endpoints are PROMIS® scores of pain interference at 7-10 post-surgery and unplanned health care utilization within 30 days. Other endpoints include patient-reported outcomes and assessments of surgeon and patient preferences. The study is funded by the Patient-Centered Outcomes Research Institute.
As of April 2025, some 5% of patients failed ureteroscopy. Another 5% had no stone found on ureteroscopy, which is consistent with prior literature reports.
“MUSIC is a community that partners to improve patients’ lives,” Dr. Ghani said. “It is my hope, my goal, that if you do a routine ureteroscopy, it becomes routine to not place a stent.”
