Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative
NCT ID: NCT05866081
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
792 participants
INTERVENTIONAL
2023-06-01
2026-05-01
Brief Summary
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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.
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Detailed Description
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As sites are activated the registration will be updated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Observational study participants (528 anticipated) will not be randomized.
TREATMENT
SINGLE
Study Groups
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Randomized cohort- No stent placement
Participants that are eligible and consent for the randomization cohort of the trial will not have a stent placed.
If participants are found to be ineligible (see below) at the end of ureteroscopy the participants will not be randomized and taken off the study.
In randomization cohort, second stage eligibility 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.
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.
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.
Randomized cohort- Stent placement
Participants that are eligible and consent for the randomization cohort trial will have a stent placed.
If participants are found to be ineligible (see below) at the end of ureteroscopy the participants will not be randomized and taken off the study.
In randomization cohort, second stage eligibility 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.
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.
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.
Observational participants - not randomized
Patients that do not consent to the randomization trial that elect to be on the observational cohort. Stent placement in the observational cohort will be decided by the surgeon intraoperatively, as per routine clinical practice.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Michigan Urological Surgery Improvement Collaborative (MUSIC)
OTHER
University of Michigan
OTHER
Responsible Party
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Khurshid Ghani
Professor of Urology
Principal Investigators
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Khurshid Ghani, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Arizona
Tucson, Arizona, United States
UF Health Shands Hospital
Gainesville, Florida, United States
Indiana University Department of Urology
Indianapolis, Indiana, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
University of Michigan Health System
Brighton, Michigan, United States
Cadillac Munson Hospital
Cadillac, Michigan, United States
St. Joseph Health System Chelsea Hospital
Chelsea, Michigan, United States
St. Joseph Mercy Health (Trinity)
Chelsea, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Corewell Health Buttersworth Hospital
Grand Rapids, Michigan, United States
E.W Sparrow Hospital
Lansing, Michigan, United States
MyMichigan Medical Center Midland
Midland, Michigan, United States
Michigan Institute of Urology Town Center Ambulatory Surgery Center
Troy, Michigan, United States
Monte Fiore
Brooklyn, New York, United States
Mount Sinai
New York, New York, United States
UNC Hospital
Chapel Hill, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Becker REN, Daignault-Newton S, Shoemaker E, Sitek D, Thelus JM, Clark S, Martin-Schwarze A, Spino C, Carlozzi NE, Meurer WJ, Sales AE, Dauw CA, Ghani KR. Stent Omission after Ureteroscopy and Lithotripsy (SOUL) in the Michigan Urological Surgery Improvement Collaborative (MUSIC): study protocol for a pragmatic prospective combined randomized and observational clinical trial. Trials. 2024 Dec 4;25(1):811. doi: 10.1186/s13063-024-08587-8.
Other Identifiers
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CER-2021C2-22856
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HUM00234740
Identifier Type: -
Identifier Source: org_study_id
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