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

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
UF Health Shands Hospital
RECRUITING
Gainesville
Michigan
University of Michigan Health System
RECRUITING
Ann Arbor
University of Michigan Health System
RECRUITING
Brighton
Cadillac Munson Hospital
RECRUITING
Cadillac
St. Joseph Health System Chelsea Hospital
RECRUITING
Chelsea
St. Joseph Mercy Health (Trinity)
RECRUITING
Chelsea
Henry Ford Health System
RECRUITING
Detroit
Corewell Health Buttersworth Hospital
RECRUITING
Grand Rapids
E.W Sparrow Hospital
RECRUITING
Lansing
MyMichigan Medical Center Midland
RECRUITING
Midland
Michigan Institute of Urology Town Center Ambulatory Surgery Center
RECRUITING
Troy
North Carolina
UNC Hospital
RECRUITING
Chapel Hill
New York
Monte Fiore
RECRUITING
Brooklyn
Mount Sinai
RECRUITING
New York
Contact Information
Primary
Elaina Shoemaker
Esekulos@med.umich.edu
734-764-3916
Backup
Sabrina Clark
sacl@med.umich.edu
734-323-9353
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 792
Treatments
Other: Randomized cohort- No stent placement
Participants that are eligible and consent for the randomization cohort of the trial will not have a stent placed.~If participants are found to be ineligible (see below) at the end of ureteroscopy the participants will not be randomized and taken off the study.~In randomization cohort, second stage eligibility 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.
Experimental: Randomized cohort- Stent placement
Participants that are eligible and consent for the randomization cohort trial will have a stent placed.~If participants are found to be ineligible (see below) at the end of ureteroscopy the participants will not be randomized and taken off the study.~In randomization cohort, second stage eligibility 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.
Other: Observational participants - not randomized
Patients that do not consent to the randomization trial that elect to be on the observational cohort. Stent placement in the observational cohort will be decided by the surgeon intraoperatively, as per routine clinical practice.
Sponsors
Leads: University of Michigan
Collaborators: Michigan Urological Surgery Improvement Collaborative (MUSIC), Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov

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