What this study is
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.
What's being tested
- Standard of care stent placement
Intervention · DEVICE
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
Intervention · OTHER
Participants not have a stent placed per randomization assigned if there are no complications (per protocol) during ureteroscopy that excludes the participant.
- Surveys
Intervention · OTHER
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.
Study details
- Official title
- Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative (SOUL MUSIC)
- Sponsor
- University of Michigan
- Conditions
- Stone, Kidney · Stone Ureter
- Enrolling
- 792 people
- Starts
- 2023-06-01
- Est. completion
- 2026-05-01
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (16)
16 openUniversity of Arizona
Tucson, Arizona, United States
- Elaina Shoemaker · Contact248-704-9671esekulos@med.umich.edu
- David Tzou, MD · Principal investigator
RecruitingUF Health Shands Hospital
Gainesville, Florida, United States
- Elaina Shoemaker · Contact734-764-3916esekulos@med.umich.edu
- John DiBianco, MD · Principal investigator
RecruitingIndiana University Department of Urology
Indianapolis, Indiana, United States
- Elaina Shoemaker · Contact248-704-9671esekulos@med.umich.edu
- Marcelino Rivera, MD · Principal investigator
RecruitingUniversity of Michigan Health System
Ann Arbor, Michigan, United States
- Sabrina Clark · Contact734-323-9353sacl@med.umich.edu
- Khurshid Ghani, MD · Principal investigator
RecruitingUniversity of Michigan Health System
Brighton, Michigan, United States
- Sabrina Clark · Contact734-323-9353sacl@med.umich.edu
- Khurshid Ghani, MD · Principal investigator
RecruitingCadillac Munson Hospital
Cadillac, Michigan, United States
- Elaina Shoemaker · Contact734-764-3916esekulos@med.umich.edu
- Laris Galejs, MD · Principal investigator
RecruitingSt. Joseph Health System Chelsea Hospital
Chelsea, Michigan, United States
- Elaina Shoemaker · Contact248-704-9671esekulos@med.umich.edu
- Andre King, MD · Principal investigator
RecruitingSt. Joseph Mercy Health (Trinity)
Chelsea, Michigan, United States
- Sabrina Clark · Contact734-323-9353sacl@med.umich.edu
- Casey Dauw, MD · Contact734-936-7030caseydau@med.umich.edu
- Casey Dauw, MD · Principal investigator
RecruitingHenry Ford Health System
Detroit, Michigan, United States
- Elaina Shoemaker · Contact248-704-9671esekulos@med.umich.edu
- David Leavitt, MD · Principal investigator
RecruitingCorewell Health Buttersworth Hospital
Grand Rapids, Michigan, United States
- Elaina Shoemaker · Contact734-764-3916esekulos@med.umich.edu
- Russell Becker, MD · Principal investigator
RecruitingE.W Sparrow Hospital
Lansing, Michigan, United States
- Elaina Shoemaker · Contact734-764-3916esekulos@med.umich.edu
- Richard Sarle, MD · Principal investigator
RecruitingMyMichigan Medical Center Midland
Midland, Michigan, United States
- Elaina Shoemaker · Contact736-764-3916esekulos@med.umich.edu
- Karla Witzke, MD · Principal investigator
RecruitingMichigan Institute of Urology Town Center Ambulatory Surgery Center
Troy, Michigan, United States
- Elaina Shoemaker · Contact734-764-3916esekulos@med.umich.edu
- Jason Hafron, MD · Principal investigator
RecruitingMonte Fiore
Brooklyn, New York, United States
- Elaina Shoemaker · Contact734-764-3916esekulos@med.umich.edu
- Dima Raskolnikov, MD · Principal investigator
RecruitingMount Sinai
New York, New York, United States
- Elaina Shoemaker · Contact734-764-3916esekulos@med.umich.edu
- Blair Gallante · Contact631-991-1159blair.gallante@mountsinai.org
- Mantu Gupta, MD · Principal investigator
RecruitingUNC Hospital
Chapel Hill, North Carolina, United States
- Elaina Shoemaker · Contact734-764-3916esekulos@med.umich.edu
- David Friedlander, MD · Principal investigator
Recruiting
Study team
Sponsor
University of Michigan
Study ID HUM00234740
Principal investigator
Khurshid Ghani, MD
University of Michigan
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.