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Led by University of Michigan · Updated on 2025-12-15
792
Participants Needed
16
Research Sites
N/A
Total Duration
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 physicians 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
E
Elaina Shoemaker
S
Sabrina Clark
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University of Michigan
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | No stent placement | Stent placement |
|---|---|---|
| What it is | Omission of postoperative ureteral stent after ureteroscopy and lithotripsy | Placement of a ureteral stent after ureteroscopy and lithotripsy |
| Role in trial | Investigational approach being tested | Standard‑of‑care comparator arm |
| Primary use | To evaluate if avoiding a stent improves patient outcomes after ureteroscopy | Usual postoperative care to maintain ureteral patency |
| How it is given or performed | No ureteral stent placed at completion of ureteroscopy if no complications | Ureteral stent is placed at the end of ureteroscopy if no complications |
| Evidence status | Evidence from randomized trials shows omitting stent yields similar 30‑day complication rates and improved patient‑reported outcomes | Routine stent placement is traditional standard though trials support that omission may be safe and better tolerated |
| Important risks | No increased postoperative complications in trials of uncomplicated cases | Known stent‑related morbidity such as urinary symptoms, pain, and patient discomfort |
| Important limitations | Applies only to uncomplicated ureteroscopy; not tested in patients with intraoperative complications or anatomical abnormalities | Can cause discomfort, urinary symptoms, and may decrease patient satisfaction |
| Patient impact | Improved patient quality‑of‑life and pain scores after ureteroscopy without stent | Stent can lead to urinary discomfort and lower satisfaction |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
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
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/University of Michigan
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
