Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative (NCT05866081)
Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative (SOUL MUSIC)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Arizona — Tucson, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (16 Sites)
- University of Arizona — Tucson, Arizona
- UF Health Shands Hospital — Gainesville, Florida
- Indiana University Department of Urology — Indianapolis, Indiana
- University of Michigan Health System — Ann Arbor, Michigan
- University of Michigan Health System — Brighton, Michigan
- Cadillac Munson Hospital — Cadillac, Michigan
- St. Joseph Health System Chelsea Hospital — Chelsea, Michigan
- St. Joseph Mercy Health (Trinity) — Chelsea, Michigan
- Henry Ford Health System — Detroit, Michigan
- Corewell Health Buttersworth Hospital — Grand Rapids, Michigan
- E.W Sparrow Hospital — Lansing, Michigan
- MyMichigan Medical Center Midland — Midland, Michigan
- Michigan Institute of Urology Town Center Ambulatory Surgery Center — Troy, Michigan
- Monte Fiore — Brooklyn, New York
- Mount Sinai — New York, New York
- UNC Hospital — Chapel Hill, North Carolina
📞 Contact the Study Coordinator
Phone: (734) 764-3916
Email: Esekulos@med.umich.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Stone, Kidney clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.