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Stent Omission After Kidney Stone Surgery

This study is looking at whether it's better to place a small tube called a stent in the ureter (the tube connecting the kidney to the bladder) after kidney stone removal surgery (ureteroscopy and lithotripsy), or to skip placing the stent. Researchers want to understand how this choice affects your pain, quality of life, and whether you need more medical care. You might be randomly assigned to either have a stent placed or not, or you could be in an observational group where your doctor decides. The study is for adults aged 18 and older who are having surgery for kidney or ureter stones that are 10 millimeters or smaller. The main goal is to see if there's a difference in pain levels 7-10 days after surgery between those who get a stent and those who don't.

Study design
This is an interventional study with both randomized and observational groups, planning to enroll 792 participants. Participants in the randomized group will be assigned by chance to either receive a stent or not.
What's involved
You will undergo ureteroscopy and lithotripsy. You will also complete surveys about your pain, quality of life, and experiences before surgery and again 7-10 days after surgery.
Compensation
Not stated in the trial record.
Follow-up
Your pain and healthcare use will be monitored up to 30 days after your ureteroscopy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05866081

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

Recruiting
NAAges 18+InterventionalTreatment
University of Michigan
~792 participants
Updated 2025-12-15 on ClinicalTrials.gov
What's tested:Standard of care stent placementNo stent placementSurveys

At a glance

Recruiting sites
16 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient Reported Outcomes Measurement Information System (PROMIS®) Pain Interference (Short Form 6b) change at Postoperative Day 7-10 compared to preoperative
Measured over Preoperative, Day 7-10
+1 more outcome measured

Conditions

Stone, Kidney
Stone Ureter

Explore related trials

NephrolithiasisUreterolithiasis

Where it's being run

16 sites across 6 states
Michigan10
New York2
Arizona1
Florida1
Indiana1
North Carolina1

Study leadership

  • Khurshid Ghani, MD · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Elaina Shoemaker
[email protected]
734-764-3916
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

Exclusion

Planned bilateral ureteroscopy
Indwelling ureteral stent or percutaneous nephrostomy tube preoperatively in either kidney
Anatomic abnormalities of the ipsilateral upper urinary tract (for example, horseshoe kidney, crossed fused ectopia, pelvic kidney, urinary diversion)
Anatomic or functional solitary kidney
Planned secondary or staged ureteroscopy
Planned use of ureteral access sheath
Pregnancy
Patients who use opiate medication daily for greater than 3 months to manage a painful condition
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.

What this trial measures

  • Patient Reported Outcomes Measurement Information System (PROMIS®) Pain Interference (Short Form 6b) change at Postoperative Day 7-10 compared to preoperativePreoperative, Day 7-10

    This survey has 6 questions that participants select from 1(not at all) to 5 (very much) for questions 1-5 related to pain interference. For question 6 participants select from 1 (Never) to 5 (Always). There are total of 6-30 points where the higher the score the more pain interference.

  • Number of Participants with Wins from the Hierarchical Unplanned stone treatment related healthcare utilization Composite Rank Scorewithin 30 days after ureteroscopy

    Compare within each cohort each No Stent Placement patient head-to-head against each Stent Placement patient using a hierarchical composite comprised of: * Intensive care unit (ICU) care during hospitalization * Unplanned hospitalization * Unplanned additional procedure related to ureteroscopy: operating room or interventional radiology procedure * Emergency department visit * Unplanned clinic visit and/or diagnostic testing (blood, urine testing and/or imaging) * Number of ambulatory patient-provider interactions: phone calls / Electronic Medical Record (EMR) messages