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RECRUITING
NCT05866081
NA

Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative

Sponsor: University of Michigan

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

OTHER

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.

OTHER

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