NCT05866081 · University of Michigan
Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative
What this study is about
This is a conducted at multiple hospitals forward-looking trial with randomly assigned 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.
View original scientific description
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.
Interventions
DEVICE
Standard of care stent placement
Participants will have a stent placed per randomization assigned if there are no complications (per protocol) during ureteroscopy that excludes the participant.
OTHER
No stent placement
Participants not have a stent placed per randomization assigned if there are no complications (per protocol) during ureteroscopy that excludes the participant.
OTHER
Surveys
All participants in the trial cohort and observational arms will be asked to complete survey instruments (evaluating their pain, quality of life, and experiences following ureteroscopy, as well as surveys evaluating their opinions and preferences around ureteral stenting, etc.). Participants will also have routine clinical data (preoperative, perioperative, and postoperative) to be collected and analyzed for research purposes.
Primary outcome measures
Patient Reported Outcomes Measurement Information System (PROMIS®) Pain Interference (Short Form 6b) change at Postoperative Day 7-10 compared to preoperative
Time frame: Preoperative, 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 Score
Time frame: within 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
- Patients who use opiate medication daily for greater than 3 months to manage a painful condition Second Stage Exclusion 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.
Where
- Tucson, Arizona
- Gainesville, Florida
- Indianapolis, Indiana
- Ann Arbor, Michigan
- Brighton, Michigan
- Cadillac, Michigan
- Chelsea, Michigan
- Detroit, Michigan
- Grand Rapids, Michigan
- Lansing, Michigan
- Midland, Michigan
- Troy, Michigan
And 3 more locations — see the full list below.
Collaborators
Patient-Centered Outcomes Research Institute, Michigan Urological Surgery Improvement Collaborative (MUSIC)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 15, 2025 · Source of record for eligibility and locations