RecruitingNot ApplicableNCT05866081

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

Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative (SOUL MUSIC)


Sponsor

University of Michigan

Enrollment

792 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether leaving out a ureteral stent after ureteroscopy and lithotripsy — a common procedure to remove kidney or ureter stones using a scope and laser — results in comparable recovery with less discomfort compared to routine stent placement. Ureteral stents are thin tubes placed inside the ureter after stone procedures to prevent blockage while the ureter heals, but they cause significant pain, urinary urgency, and reduced quality of life in many patients, and require a second procedure to remove. Adults undergoing ureteroscopy for kidney or ureter stones that are 10mm or smaller, with no pre-existing ureteral stents, normal urinary tract anatomy, and access to communication with the research team are eligible. Patients planning bilateral procedures, those with anatomic urinary abnormalities, a solitary kidney, planned staged procedures, or those taking daily opioids for pain are excluded. Participants are enrolled intraoperatively if the procedure goes smoothly, then randomized to stent omission or standard stenting, and followed up for pain, urinary symptoms, and complications. This research is significant because kidney stones affect roughly 10% of the population over a lifetime, ureteroscopy is among the most commonly performed urological procedures, and reducing stent use in appropriate patients could improve the experience of recovery for hundreds of thousands of patients annually.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEStandard 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.

OTHERNo stent placement

Participants not have a stent placed per randomization assigned if there are no complications (per protocol) during ureteroscopy that excludes the participant.

OTHERSurveys

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

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NCT05866081


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