Actively Recruiting
Led by University of Michigan · Updated on 2025-12-15
792
Participants Needed
16
Research Sites
N/A
Total Duration
U
University of Michigan
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
Researchers are evaluating patient-reported outcomes and unplanned healthcare use after ureteroscopic treatment for kidney and ureteral stones. This study compares outcomes between patients who receive a ureteral stent after surgery and those who do not. The trial includes both randomized and observational groups, with hypotheses focused on differences in pain interference and healthcare utilization between these groups. Participants in the randomized group are assigned to either receive a stent or have no stent placed, provided no complications occur during ureteroscopy. Patients in the observational group receive treatment decisions based on their physician's usual practice. The study excludes participants who experience certain complications during surgery, such as ureteral perforation or significant bleeding. During participation, patients complete surveys about pain, quality of life, and their experiences following ureteroscopy. Clinical data before, during, and after surgery are collected. The main outcomes measured include changes in pain interference at 7 to 10 days post-surgery and unplanned healthcare visits within 30 days. Additional assessments of pain, urinary symptoms, treatment satisfaction, and time off work are conducted up to 4 to 6 weeks after surgery.
CONDITIONS
Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo ureteroscopy and lithotripsy for stone disease. Based on randomization and eligibility during surgery, participants either have a ureteral stent placed or do not have a stent placed.
1 visit (in-person)
Duration - Up to 6 weeks after surgery
Participants complete surveys evaluating pain, quality of life, and experiences following ureteroscopy, along with routine clinical data collection during the recovery period.
Visits and surveys at postoperative days 7-10 and 4-6 weeks
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
E
Elaina Shoemaker
S
Sabrina Clark
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Russell E N Becker, Stephanie Daignault-Newton, Elaina Shoemaker...
https://pubmed.ncbi.nlm.nih.gov/39633425