SOUL MUSIC

"The Stent Omission after Ureteroscopy and Lithotripsy (SOUL) study," conducted within the Michigan Urological Surgery Improvement Collaborative (MUSIC), is a pragmatic, multi-center investigation designed to address a critical evidence gap in postoperative care for patients undergoing ureteroscopy for upper urinary tract stones. Professional society guidelines suggest stent omission after uncomplicated ureteroscopy, yet most patients more than 80% still receive ureteral stents. This discordance is driven in part by limited high-quality evidence regarding the comparative effects of stent placement versus omission on patient-centered outcomes, including pain, urinary symptoms, health-related quality of life (HRQOL), and unplanned healthcare utilization. The SOUL study was developed with patient partners to ensure relevance to patient priorities and feasibility in routine practice.

SOUL employs a combined randomized and observational cohort design to maximize generalizability and capture real-world decision-making. Eligible patients are prospectively enrolled into a randomized cohort when they consent to randomization; assignment to ureteral stent omission versus placement is determined intraoperatively using a web-based randomization platform. Patients who decline randomization are invited to participate in an observational cohort where stent use is left to the treating urologist discretion. By including both cohorts, the study intends to reflect both controlled comparative effectiveness evidence and pragmatic, clinician- and patient-driven care patterns, addressing the challenge that many patients are reluctant to be randomized in surgical trials.

Participants in both cohorts complete preoperative and postoperative patient-reported outcome (PRO) assessments capturing pain, urinary symptoms, interference with usual activities, time taken off work or school, and treatment satisfaction. The study also evaluates unplanned healthcare utilization within 30 days postoperatively through electronic health record review and records severe adverse events. A qualitative component complements quantitative outcomes: a purposive subgroup of patients and urologists will engage in semi-structured interviews exploring knowledge, preferences, and practice patterns regarding ureteral stenting. Interview data will be thematically analyzed to identify barriers and facilitators to practice change.

By measuring HRQOL and short-term healthcare utilization, SOUL seeks to determine whether omitting ureteral stents after uncomplicated ureteroscopy reduces stent-related symptoms without increasing complications or unplanned care. The inclusion of patient partners in study design and the combination of randomized and observational data help ensure the studys findings will be meaningful to patients, clinicians, and health systems. Registered on ClinicalTrials.gov (NCT05866081), and funded by the Patient-Centered Outcomes Research Institute with support for MUSIC from Blue Cross Blue Shield of Michigan, this trial addresses a high-priority clinical question with implications for patient comfort, shared decision-making and evidence-based guideline implementation.