Actively Recruiting
Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative
Led by University of Michigan · Updated on 2025-12-15
792
Participants Needed
16
Research Sites
152 weeks
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing unilateral ureteroscopy and lithotripsy for stone disease (contralateral stones must be asymptomatic and untreated)
- Largest stone is 10 millimeters or smaller as measured by abdominal x-ray, ultrasound, or CT scan
- Access to communication methods such as email, text messaging, or telephone
- Adequate cognitive function and English proficiency to complete surveys
- Provided written informed consent
You will not qualify if you...
- Planned bilateral ureteroscopy
- Existing ureteral stent or nephrostomy tube in either kidney before surgery
- Anatomic abnormalities of the ipsilateral upper urinary tract (e.g., horseshoe kidney, crossed fused ectopia, pelvic kidney, urinary diversion)
- Solitary kidney due to anatomy or function
- Planned secondary or staged ureteroscopy
- Planned use of ureteral access sheath
- Pregnancy
- Daily opioid medication use for over 3 months to manage pain
- Ureteral perforation during surgery
- Unexpected anatomic abnormalities found during surgery
- Excessive bleeding during surgery
- Ureteral dilation greater than 12 French
- Use of ureteral access sheath during surgery
- Failed ureteroscopy
- No or incomplete lithotripsy performed
- Surgery incomplete due to medical or anesthetic issues
AI-Screening
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Trial Site Locations
Total: 16 locations
1
University of Arizona
Tucson, Arizona, United States, 85724
Actively Recruiting
2
UF Health Shands Hospital
Gainesville, Florida, United States, 32608
Actively Recruiting
3
Indiana University Department of Urology
Indianapolis, Indiana, United States, 46202
Actively Recruiting
4
University of Michigan Health System
Ann Arbor, Michigan, United States, 48111
Actively Recruiting
5
University of Michigan Health System
Brighton, Michigan, United States, 48116
Actively Recruiting
6
Cadillac Munson Hospital
Cadillac, Michigan, United States, 49601
Actively Recruiting
7
St. Joseph Health System Chelsea Hospital
Chelsea, Michigan, United States, 48118
Actively Recruiting
8
St. Joseph Mercy Health (Trinity)
Chelsea, Michigan, United States, 48118
Actively Recruiting
9
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
10
Corewell Health Buttersworth Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
11
E.W Sparrow Hospital
Lansing, Michigan, United States, 48912
Actively Recruiting
12
MyMichigan Medical Center Midland
Midland, Michigan, United States, 48670
Actively Recruiting
13
Michigan Institute of Urology Town Center Ambulatory Surgery Center
Troy, Michigan, United States, 48084
Actively Recruiting
14
Monte Fiore
Brooklyn, New York, United States, 10467
Actively Recruiting
15
Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
16
UNC Hospital
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
Research Team
E
Elaina Shoemaker
CONTACT
S
Sabrina Clark
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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