Stone, KidneyNCT05866081
Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative
A study testing No stent placement and Surveys in people with Stone, Kidney and Stone Ureter, run by University of Michigan at 16 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stone, Kidney, Stone Ureter
- What is being tested?
- No stent placement and Surveys
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 792 participants
- Where
- 16 sitesUnited States
- Study dates
- 1 Jun 2023to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- Pregnancy
- 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.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United States16 sites, 16 recruiting
- Recruiting
University of Michigan Health System
Ann Arbor, Michigan, 48111
Sabrina Clark, 734-323-9353, sacl@med.umich.edu
Khurshid Ghani, MD
- Recruiting
University of Michigan Health System
Brighton, Michigan, 48116
Sabrina Clark, 734-323-9353, sacl@med.umich.edu
Khurshid Ghani, MD
- Recruiting
Monte Fiore
Brooklyn, New York, 10467
Elaina Shoemaker, 734-764-3916, esekulos@med.umich.edu
Dima Raskolnikov, MD
- Recruiting
Cadillac Munson Hospital
Cadillac, Michigan, 49601
Elaina Shoemaker, 734-764-3916, esekulos@med.umich.edu
Laris Galejs, MD
- Recruiting
UNC Hospital
Chapel Hill, North Carolina, 27514
Elaina Shoemaker, 734-764-3916, esekulos@med.umich.edu
David Friedlander, MD
- Recruiting
St. Joseph Health System Chelsea Hospital
Chelsea, Michigan, 48118
Elaina Shoemaker, 248-704-9671, esekulos@med.umich.edu
Andre King, MD
- Recruiting
St. Joseph Mercy Health (Trinity)
Chelsea, Michigan, 48118
Sabrina Clark, 734-323-9353, sacl@med.umich.edu
Casey Dauw, MD, 734-936-7030, caseydau@med.umich.edu
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
Elaina Shoemaker, 248-704-9671, esekulos@med.umich.edu
David Leavitt, MD
- Recruiting
UF Health Shands Hospital
Gainesville, Florida, 32608
Elaina Shoemaker, 734-764-3916, esekulos@med.umich.edu
John DiBianco, MD
- Recruiting
Corewell Health Buttersworth Hospital
Grand Rapids, Michigan, 49503
Elaina Shoemaker, 734-764-3916, esekulos@med.umich.edu
Russell Becker, MD
- Recruiting
Indiana University Department of Urology
Indianapolis, Indiana, 46202
Elaina Shoemaker, 248-704-9671, esekulos@med.umich.edu
Marcelino Rivera, MD
- Recruiting
E.W Sparrow Hospital
Lansing, Michigan, 48912
Elaina Shoemaker, 734-764-3916, esekulos@med.umich.edu
Richard Sarle, MD
- Recruiting
MyMichigan Medical Center Midland
Midland, Michigan, 48670
Elaina Shoemaker, 736-764-3916, esekulos@med.umich.edu
Karla Witzke, MD
- Recruiting
Mount Sinai
New York, New York, 10029
Elaina Shoemaker, 734-764-3916, esekulos@med.umich.edu
Blair Gallante, 631-991-1159, blair.gallante@mountsinai.org
- Recruiting
Michigan Institute of Urology Town Center Ambulatory Surgery Center
Troy, Michigan, 48084
Elaina Shoemaker, 734-764-3916, esekulos@med.umich.edu
Jason Hafron, MD
- Recruiting
University of Arizona
Tucson, Arizona, 85724
Elaina Shoemaker, 248-704-9671, esekulos@med.umich.edu
David Tzou, MD
About this study
Official title: Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative (SOUL MUSIC)
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.
Read more
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.
Read the detailed description
The coordinating center for this study is the Michigan Urological Surgery Improvement Collaborative (MUSIC), which is a physician-led Quality Improvement (QI) collaborative comprised of 44 urology practices and 260 urologists across the State of Michigan.
As sites are activated the registration will be updated.
- Conditions
- Stone, Kidney, Stone Ureter
- Being tested
- Standard of care stent placement, No stent placement, Surveys
- Keywords
- Unilateral ureteroscopy and lithotripsy, Ureteral stent, Pain assessment, Quality of life
- Medical subject headings
- Kidney Calculi, Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care stent placementDevice
Participants will have a stent placed per randomization assigned if there are no complications (per protocol) during ureteroscopy that excludes the participant.
No stent placementOther
Participants not have a stent placed per randomization assigned if there are no complications (per protocol) during ureteroscopy that excludes the participant.
SurveysOther
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 group | Role | What they receive |
|---|---|---|
| Randomized cohort- No stent placement | Other | 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. Receives: Other: No stent placement; Other: Surveys |
| Randomized cohort- Stent placement | Experimental | 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. Receives: Device: Standard of care stent placement; Other: Surveys |
| Observational participants - not randomized | Other | 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. Receives: Other: Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Outcomes Measurement Information System (PROMIS®) Pain Interference (Short Form 6b) change at Postoperative Day 7-10 compared to preoperative
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.
Measured: Preoperative, Day 7-10
Number of Participants with Wins from the Hierarchical Unplanned stone treatment related healthcare utilization Composite Rank Score
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
Measured: within 30 days after ureteroscopy
Secondary outcomes (14)
Number of Participants with Intensive Care Unit care during unplanned hospital admission within postoperative day 30
Measured: within 30 days after ureteroscopy
Number of Participants with Unplanned hospital admission within postoperative day 30
Measured: within 30 days after ureteroscopy
Number of Participants with Unplanned additional procedure related to ureteroscopy within postoperative day 30
Measured: within 30 days after ureteroscopy
Number of Participants with Unplanned ambulatory urology office visit and/or diagnostic testing (urine testing and/or imaging) within postoperative day 30
Measured: within 30 days after ureteroscopy
Unplanned ambulatory urology office visit and/or diagnostic testing (urine testing and/or imaging) within postoperative day 30
Measured: within 30 days after ureteroscopy
Number of ambulatory patient-provider interactions: phone calls / EMR messages within postoperative day 30
Measured: within 30 days after ureteroscopy
PROMIS® Pain Interference (Short Form 6b) change at postoperative 4-6 weeks compared to preoperative
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 intensity.
Measured: preoperative, 4-6 weeks
PROMIS® Pain Intensity (Short Form 3a) change at postoperative day 7-10 preoperative
This is a 3-question survey that participants select from 1 (had no pain) to 5 (very severe) for the first 2 questions. For the third question participants select how level of pain is now 1 (no pain) to 5 (very severe). There are total of 3-15 points where the higher the score the more pain intensity.
Measured: preoperative, postoperative day 7-10
PROMIS® Pain Intensity (Short Form 3a) change at postoperative 4-6 weeks compared to preoperative
This is a 3-question survey that participants select from 1 (had no pain) to 5 (very severe) for the first 2 questions. For the third question participants select how level of pain is now 1 (no pain) to 5 (very severe). There are total of 3-15 points where the higher the score the more pain interference.
Measured: preoperative, postoperative 4-6 weeks
National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptom Index-10 urinary symptom scores change at postoperative day 7-10 compared to preoperative
The is 10-Item index that assesses participants urinary symptoms. For questions 1-8 Participants select from 0 (never)-4 every time. For questions 9 and 10 participants select from 0 (none) -3 (more than 3 times). There are total of 0-38 points where the higher the score the more pain symptoms.
Measured: preoperative, postoperative day 7-10
National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptom Index-10 urinary symptom scores change at postoperative 4-6 weeks compared to preoperative
The is 10-Item index that assesses participants urinary symptoms. For questions 1-8 Participants select from 0 (never)-4 every time. For questions 9 and 10 participants select from 0 (none) -3 (more than 3 times). There are total of 0-38 points where the higher the score the more pain intensity.
Measured: preoperative, postoperative 4-6 weeks
International Consultation on Incontinence - Satisfaction (ICIQ-S) treatment satisfaction scores at postoperative day 7-10
Participants will complete this 14-question survey regarding satisfaction of treatment.
The ICIQ-S assesses aspects of experience, expectations, and outcomes to evaluate satisfaction after urological surgery. A scoring system has been derived that consists of two parts: a score for the evaluation of satisfaction with 'surgical outcomes' (ICIQ-S outcome score, range 0-24); and the overall satisfaction with surgery item, scored 0-10. Higher scores indicate more satisfaction.
Measured: Postoperative day 7-10
International Consultation on Incontinence - Satisfaction (ICIQ-S) treatment satisfaction scores at postoperative 4-6 weeks
Participants will complete this 14-question survey regarding satisfaction of treatment.
The ICIQ-S assesses aspects of experience, expectations, and outcomes to evaluate satisfaction after urological surgery. A scoring system has been derived that consists of two parts: a score for the evaluation of satisfaction with 'surgical outcomes' (ICIQ-S outcome score, range 0-24); and the overall satisfaction with surgery item, scored 0-10. Higher scores indicate more satisfaction.
Measured: Postoperative 4-6 weeks
Number of days taken off work by patients and caregivers during the first 7 days after ureteroscopy
Measured: First 7 days after ureteroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start1 Jun 2023
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stone, KidneyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants that consent for the randomization cohort (264 anticipated) will be randomized using an online computer-based system to either stent omission or stent placement in a 1:1 ratio following secondary eligibility criteria. Blocked, stratified randomization based upon surgeon classified stone location (renal only versus ureteral with or without renal), with random block sizes will be used to ensure group balance. Observational study participants (528 anticipated) will not be randomized.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 792 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Michigan Urological Surgery Improvement Collaborative (MUSIC)
- Responsible party
- Principal investigator, Khurshid Ghani, University of Michigan
- Investigators
- Khurshid Ghani, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866081
- Sponsor's protocol ID
- HUM00234740
- Other IDs
- CER-2021C2-22856
- Status last verified
- Dec 2025
- First submitted
- 24 Apr 2023
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 39633425
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative (SOUL MUSIC)
- ClinicalTrials.gov ID
- NCT05866081
- Acronym / sponsor ID
- HUM00234740
- Conditions
- Stone, Kidney, Stone Ureter
- Keywords
- Unilateral ureteroscopy and lithotripsy, Ureteral stent, Pain assessment, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 792 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Michigan Urological Surgery Improvement Collaborative (MUSIC)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The coordinating center for this study is the Michigan Urological Surgery Improvement Collaborative (MUSIC), which is a physician-led Quality Improvement (QI) collaborative comprised of 44 urology practices and 260 urologists across the State of Michigan.
As sites are activated the registration will be updated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
- Model description
- Participants that consent for the randomization cohort (264 anticipated) will be randomized using an online computer-based system to either stent omission or stent placement in a 1:1 ratio following secondary eligibility criteria. Blocked, stratified randomization based upon surgeon classified stone location (renal only versus ureteral with or without renal), with random block sizes will be used to ensure group balance. Observational study participants (528 anticipated) will not be randomized.
| Arm | Type | Receives |
|---|---|---|
| Randomized cohort- No stent placement | Other | Other: No stent placement, Other: SurveysParticipants 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. |
| Randomized cohort- Stent placement | Experimental | Device: Standard of care stent placement, Other: SurveysParticipants 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. |
| Observational participants - not randomized | Other | Other: SurveysPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care stent placementParticipants will have a stent placed per randomization assigned if there are no complications (per protocol) during ureteroscopy that excludes the participant. | Device | Randomized cohort- Stent placement |
| No stent placementParticipants not have a stent placed per randomization assigned if there are no complications (per protocol) during ureteroscopy that excludes the participant. | Other | Randomized cohort- No stent placement |
| SurveysAll 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. | Other | Observational participants - not randomized, Randomized cohort- No stent placement, Randomized cohort- Stent placement |
Primary outcome
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
14 secondary outcomes
Number of Participants with Intensive Care Unit care during unplanned hospital admission within postoperative day 30
Time frame: within 30 days after ureteroscopy
Number of Participants with Unplanned hospital admission within postoperative day 30
Time frame: within 30 days after ureteroscopy
Number of Participants with Unplanned additional procedure related to ureteroscopy within postoperative day 30
Time frame: within 30 days after ureteroscopy
Number of Participants with Unplanned ambulatory urology office visit and/or diagnostic testing (urine testing and/or imaging) within postoperative day 30
Time frame: within 30 days after ureteroscopy
Unplanned ambulatory urology office visit and/or diagnostic testing (urine testing and/or imaging) within postoperative day 30
Time frame: within 30 days after ureteroscopy
Number of ambulatory patient-provider interactions: phone calls / EMR messages within postoperative day 30
Time frame: within 30 days after ureteroscopy
PROMIS® Pain Interference (Short Form 6b) change at postoperative 4-6 weeks compared to preoperative
Time frame: preoperative, 4-6 weeks
PROMIS® Pain Intensity (Short Form 3a) change at postoperative day 7-10 preoperative
Time frame: preoperative, postoperative day 7-10
PROMIS® Pain Intensity (Short Form 3a) change at postoperative 4-6 weeks compared to preoperative
Time frame: preoperative, postoperative 4-6 weeks
National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptom Index-10 urinary symptom scores change at postoperative day 7-10 compared to preoperative
Time frame: preoperative, postoperative day 7-10
National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptom Index-10 urinary symptom scores change at postoperative 4-6 weeks compared to preoperative
Time frame: preoperative, postoperative 4-6 weeks
International Consultation on Incontinence - Satisfaction (ICIQ-S) treatment satisfaction scores at postoperative day 7-10
Time frame: Postoperative day 7-10
International Consultation on Incontinence - Satisfaction (ICIQ-S) treatment satisfaction scores at postoperative 4-6 weeks
Time frame: Postoperative 4-6 weeks
Number of days taken off work by patients and caregivers during the first 7 days after ureteroscopy
Time frame: First 7 days after ureteroscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Derived from this study: PubMed 39633425Becker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Khurshid Ghani, MD principal investigator
University of Michigan
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No stent placement and Surveys in people with Stone, Kidney and Stone Ureter, run by University of Michigan at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elaina Shoemaker (734-764-3916, Esekulos@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05866081, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.