Clinical Research Directory
Browse clinical research sites, groups, and studies.
Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative
Sponsor: University of Michigan
Summary
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.
Official title: Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative (SOUL MUSIC)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
792
Start Date
2023-06-01
Completion Date
2026-05-01
Last Updated
2025-12-15
Healthy Volunteers
No
Conditions
Interventions
Standard of care stent placement
Participants will have a stent placed per randomization assigned if there are no complications (per protocol) during ureteroscopy that excludes the participant.
No stent placement
Participants not have a stent placed per randomization assigned if there are no complications (per protocol) during ureteroscopy that excludes the participant.
Surveys
All participants in the trial cohort and observational arms will be asked to complete survey instruments (evaluating their pain, quality of life, and experiences following ureteroscopy, as well as surveys evaluating their opinions and preferences around ureteral stenting, etc.). Participants will also have routine clinical data (preoperative, perioperative, and postoperative) to be collected and analyzed for research purposes.
Locations (16)
University of Arizona
Tucson, Arizona, United States
UF Health Shands Hospital
Gainesville, Florida, United States
Indiana University Department of Urology
Indianapolis, Indiana, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
University of Michigan Health System
Brighton, Michigan, United States
Cadillac Munson Hospital
Cadillac, Michigan, United States
St. Joseph Health System Chelsea Hospital
Chelsea, Michigan, United States
St. Joseph Mercy Health (Trinity)
Chelsea, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Corewell Health Buttersworth Hospital
Grand Rapids, Michigan, United States
E.W Sparrow Hospital
Lansing, Michigan, United States
MyMichigan Medical Center Midland
Midland, Michigan, United States
Michigan Institute of Urology Town Center Ambulatory Surgery Center
Troy, Michigan, United States
Monte Fiore
Brooklyn, New York, United States
Mount Sinai
New York, New York, United States
UNC Hospital
Chapel Hill, North Carolina, United States