SOUL MUSIC

This is a multicenter prospective trial with randomized and observational cohorts assessing patient-reported outcomes and unplanned healthcare utilization following ureteroscopic treatment of renal and ureteral stones, with placement versus omission of a ureteral stent.

Eligible participants in the randomization trial will be randomized to ureteroscopy with stent placement or stent omission.

Eligible participants that consent to the observational only cohort will complete surveys and the treating physicians will decide the treatment options for the participants.

The study team hypothesizes that:

• Pain interference change from pre-surgery to Day 7-10 will differ between the two treatment arms. This hypothesis will be evaluated separately in the randomized and observational cohorts.

• Unplanned healthcare utilization in the treatment arms will have different unplanned healthcare utilization ranks leading to a win proportion significantly higher or lower than 0.5 in the stent omission arm compared to the stent placement arm. This hypothesis will be evaluated separately in the randomized and observational cohorts.

The coordinating center for this study is the Michigan Urological Surgery Improvement Collaborative (MUSIC), which is a physician-led Quality Improvement (QI) collaborative comprised of 44 urology practices and 260 urologists across the State of Michigan.

As sites are activated the registration will be updated.

Inclusion Criteria:

• Undergoing unilateral ureteroscopy and lithotripsy for stone disease (participants may have contralateral stones, as long as these are asymptomatic and not being treated concurrently)

• Largest stone less or equal to 10 millimeter in size as measured on abdominal x-ray, ultrasound, or computed tomography scan

• Access to means of communication with the study team (email, text messaging, and/or telephone)

• Adequate independent cognitive function and English language proficiency to complete study surveys

• Written informed consent

Exclusion Criteria:

• Planned bilateral ureteroscopy

• Indwelling ureteral stent or percutaneous nephrostomy tube preoperatively in either kidney

• Anatomic abnormalities of the ipsilateral upper urinary tract (for example, horseshoe kidney, crossed fused ectopia, pelvic kidney, urinary diversion)

• Anatomic or functional solitary kidney

• Planned secondary or staged ureteroscopy

• Planned use of ureteral access sheath

• Pregnancy

• Patients who use opiate medication daily for greater than 3 months to manage a painful condition

Second Stage Exclusion Criteria:

• ureteral perforation

• unanticipated anatomic abnormality

• greater than expected bleeding

• ureteral dilation greater than 12 French

• ureteral access sheath utilized

• failed ureteroscopy

• no or incomplete lithotripsy performed

• unable to complete case due to medical or anesthetic event.