[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05866081":3,"trial-entities:NCT05866081":338,"trial-summary:NCT05866081":343},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":50,"secondary_outcomes":59,"sex":100,"minimum_age":101,"maximum_age":102,"healthy_volunteers":103,"eligibility_criteria":104,"std_ages":129,"locations":132,"central_contacts":326,"overall_officials":330,"references":332,"see_also_links":337},"NCT05866081","HUM00234740","Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative","Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative (SOUL MUSIC)","RECRUITING","2026-05-01","2025-12","2025-12-15","2023-06-01","University of Michigan","OTHER",true,"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.\n\nEligible participants in the randomization trial will be randomized to ureteroscopy with stent placement or stent omission.\n\nEligible participants that consent to the observational only cohort will complete surveys and the treating physicians will decide the treatment options for the participants.\n\nThe study team hypothesizes that:\n\n* 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.\n* 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.","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.\n\nAs sites are activated the registration will be updated.",[19,20],"Stone, Kidney","Stone Ureter",[22,23,24,25],"Unilateral ureteroscopy and lithotripsy","Ureteral stent","Pain assessment","Quality of life","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},792,"ESTIMATED",[34,40,45],{"type":35,"name":36,"description":37,"armGroupLabels":38},"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.",[39],"Randomized cohort- Stent placement",{"type":14,"name":41,"description":42,"armGroupLabels":43},"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.",[44],"Randomized cohort- No stent placement",{"type":14,"name":46,"description":47,"armGroupLabels":48},"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.).\n\nParticipants will also have routine clinical data (preoperative, perioperative, and postoperative) to be collected and analyzed for research purposes.",[49,44,39],"Observational participants - not randomized",[51,55],{"measure":52,"description":53,"timeFrame":54},"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.","Preoperative, Day 7-10",{"measure":56,"description":57,"timeFrame":58},"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:\n\n* Intensive care unit (ICU) care during hospitalization\n* Unplanned hospitalization\n* Unplanned additional procedure related to ureteroscopy: operating room or interventional radiology procedure\n* Emergency department visit\n* Unplanned clinic visit and\u002For diagnostic testing (blood, urine testing and\u002For imaging)\n* Number of ambulatory patient-provider interactions: phone calls \u002F Electronic Medical Record (EMR) messages","within 30 days after ureteroscopy",[60,62,64,66,68,70,72,76,80,84,87,90,94,97],{"measure":61,"timeFrame":58},"Number of Participants with Intensive Care Unit care during unplanned hospital admission within postoperative day 30",{"measure":63,"timeFrame":58},"Number of Participants with Unplanned hospital admission within postoperative day 30",{"measure":65,"timeFrame":58},"Number of Participants with Unplanned additional procedure related to ureteroscopy within postoperative day 30",{"measure":67,"timeFrame":58},"Number of Participants with Unplanned ambulatory urology office visit and\u002For diagnostic testing (urine testing and\u002For imaging) within postoperative day 30",{"measure":69,"timeFrame":58},"Unplanned ambulatory urology office visit and\u002For diagnostic testing (urine testing and\u002For imaging) within postoperative day 30",{"measure":71,"timeFrame":58},"Number of ambulatory patient-provider interactions: phone calls \u002F EMR messages within postoperative day 30",{"measure":73,"description":74,"timeFrame":75},"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.","preoperative, 4-6 weeks",{"measure":77,"description":78,"timeFrame":79},"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.","preoperative, postoperative day 7-10",{"measure":81,"description":82,"timeFrame":83},"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.","preoperative, postoperative 4-6 weeks",{"measure":85,"description":86,"timeFrame":79},"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.",{"measure":88,"description":89,"timeFrame":83},"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.",{"measure":91,"description":92,"timeFrame":93},"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.\n\nThe 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.","Postoperative day 7-10",{"measure":95,"description":92,"timeFrame":96},"International Consultation on Incontinence - Satisfaction (ICIQ-S) treatment satisfaction scores at postoperative 4-6 weeks","Postoperative 4-6 weeks",{"measure":98,"timeFrame":99},"Number of days taken off work by patients and caregivers during the first 7 days after ureteroscopy","First 7 days after ureteroscopy","ALL","18 Years",null,false,{"inclusion":105,"exclusion":111,"raw_text":128},[106,107,108,109,110],"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\u002For telephone)","Adequate independent cognitive function and English language proficiency to complete study surveys","Written informed consent",[112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127],"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.","Inclusion Criteria:\n\n* Undergoing unilateral ureteroscopy and lithotripsy for stone disease (participants may have contralateral stones, as long as these are asymptomatic and not being treated concurrently)\n* Largest stone less or equal to 10 millimeter in size as measured on abdominal x-ray, ultrasound, or computed tomography scan\n* Access to means of communication with the study team (email, text messaging, and\u002For telephone)\n* Adequate independent cognitive function and English language proficiency to complete study surveys\n* Written informed consent\n\nExclusion Criteria:\n\n* Planned bilateral ureteroscopy\n* Indwelling ureteral stent or percutaneous nephrostomy tube preoperatively in either kidney\n* Anatomic abnormalities of the ipsilateral upper urinary tract (for example, horseshoe kidney, crossed fused ectopia, pelvic kidney, urinary diversion)\n* Anatomic or functional solitary kidney\n* Planned secondary or staged ureteroscopy\n* Planned use of ureteral access sheath\n* Pregnancy\n* Patients who use opiate medication daily for greater than 3 months to manage a painful condition\n\nSecond Stage Exclusion Criteria:\n\n* ureteral perforation\n* unanticipated anatomic abnormality\n* greater than expected bleeding\n* ureteral dilation greater than 12 French\n* ureteral access sheath utilized\n* failed ureteroscopy\n* no or incomplete lithotripsy performed\n* unable to complete case due to medical or anesthetic event.",[130,131],"ADULT","OLDER_ADULT",[133,151,164,176,191,200,211,222,232,243,254,265,277,288,300,314],{"facility":134,"status":8,"city":135,"state":136,"zip":137,"country":138,"contacts":139,"geoPoint":148},"University of Arizona","Tucson","Arizona","85724","United States",[140,145],{"name":141,"role":142,"phone":143,"email":144},"Elaina Shoemaker","CONTACT","248-704-9671","esekulos@med.umich.edu",{"name":146,"role":147},"David Tzou, MD","PRINCIPAL_INVESTIGATOR",{"lat":149,"lon":150},32.22174,-110.92648,{"facility":152,"status":8,"city":153,"state":154,"zip":155,"country":138,"contacts":156,"geoPoint":161},"UF Health Shands Hospital","Gainesville","Florida","32608",[157,159],{"name":141,"role":142,"phone":158,"email":144},"734-764-3916",{"name":160,"role":147},"John DiBianco, MD",{"lat":162,"lon":163},29.65163,-82.32483,{"facility":165,"status":8,"city":166,"state":167,"zip":168,"country":138,"contacts":169,"geoPoint":173},"Indiana University Department of Urology","Indianapolis","Indiana","46202",[170,171],{"name":141,"role":142,"phone":143,"email":144},{"name":172,"role":147},"Marcelino Rivera, MD",{"lat":174,"lon":175},39.76838,-86.15804,{"facility":177,"status":8,"city":178,"state":179,"zip":180,"country":138,"contacts":181,"geoPoint":188},"University of Michigan Health System","Ann Arbor","Michigan","48111",[182,186],{"name":183,"role":142,"phone":184,"email":185},"Sabrina Clark","734-323-9353","sacl@med.umich.edu",{"name":187,"role":147},"Khurshid Ghani, MD",{"lat":189,"lon":190},42.27756,-83.74088,{"facility":177,"status":8,"city":192,"state":179,"zip":193,"country":138,"contacts":194,"geoPoint":197},"Brighton","48116",[195,196],{"name":183,"role":142,"phone":184,"email":185},{"name":187,"role":147},{"lat":198,"lon":199},42.52948,-83.78022,{"facility":201,"status":8,"city":202,"state":179,"zip":203,"country":138,"contacts":204,"geoPoint":208},"Cadillac Munson Hospital","Cadillac","49601",[205,206],{"name":141,"role":142,"phone":158,"email":144},{"name":207,"role":147},"Laris Galejs, MD",{"lat":209,"lon":210},44.25195,-85.40116,{"facility":212,"status":8,"city":213,"state":179,"zip":214,"country":138,"contacts":215,"geoPoint":219},"St. Joseph Health System Chelsea Hospital","Chelsea","48118",[216,217],{"name":141,"role":142,"phone":143,"email":144},{"name":218,"role":147},"Andre King, MD",{"lat":220,"lon":221},42.31807,-84.02181,{"facility":223,"status":8,"city":213,"state":179,"zip":214,"country":138,"contacts":224,"geoPoint":231},"St. Joseph Mercy Health (Trinity)",[225,226,230],{"name":183,"role":142,"phone":184,"email":185},{"name":227,"role":142,"phone":228,"email":229},"Casey Dauw, MD","734-936-7030","caseydau@med.umich.edu",{"name":227,"role":147},{"lat":220,"lon":221},{"facility":233,"status":8,"city":234,"state":179,"zip":235,"country":138,"contacts":236,"geoPoint":240},"Henry Ford Health System","Detroit","48202",[237,238],{"name":141,"role":142,"phone":143,"email":144},{"name":239,"role":147},"David Leavitt, MD",{"lat":241,"lon":242},42.33143,-83.04575,{"facility":244,"status":8,"city":245,"state":179,"zip":246,"country":138,"contacts":247,"geoPoint":251},"Corewell Health Buttersworth Hospital","Grand Rapids","49503",[248,249],{"name":141,"role":142,"phone":158,"email":144},{"name":250,"role":147},"Russell Becker, MD",{"lat":252,"lon":253},42.96336,-85.66809,{"facility":255,"status":8,"city":256,"state":179,"zip":257,"country":138,"contacts":258,"geoPoint":262},"E.W Sparrow Hospital","Lansing","48912",[259,260],{"name":141,"role":142,"phone":158,"email":144},{"name":261,"role":147},"Richard Sarle, MD",{"lat":263,"lon":264},42.73253,-84.55553,{"facility":266,"status":8,"city":267,"state":179,"zip":268,"country":138,"contacts":269,"geoPoint":274},"MyMichigan Medical Center Midland","Midland","48670",[270,272],{"name":141,"role":142,"phone":271,"email":144},"736-764-3916",{"name":273,"role":147},"Karla Witzke, MD",{"lat":275,"lon":276},43.61558,-84.24721,{"facility":278,"status":8,"city":279,"state":179,"zip":280,"country":138,"contacts":281,"geoPoint":285},"Michigan Institute of Urology Town Center Ambulatory Surgery Center","Troy","48084",[282,283],{"name":141,"role":142,"phone":158,"email":144},{"name":284,"role":147},"Jason Hafron, MD",{"lat":286,"lon":287},42.60559,-83.14993,{"facility":289,"status":8,"city":290,"state":291,"zip":292,"country":138,"contacts":293,"geoPoint":297},"Monte Fiore","Brooklyn","New York","10467",[294,295],{"name":141,"role":142,"phone":158,"email":144},{"name":296,"role":147},"Dima Raskolnikov, MD",{"lat":298,"lon":299},40.6501,-73.94958,{"facility":301,"status":8,"city":291,"state":291,"zip":302,"country":138,"contacts":303,"geoPoint":311},"Mount Sinai","10029",[304,305,309],{"name":141,"role":142,"phone":158,"email":144},{"name":306,"role":142,"phone":307,"email":308},"Blair Gallante","631-991-1159","blair.gallante@mountsinai.org",{"name":310,"role":147},"Mantu Gupta, MD",{"lat":312,"lon":313},40.71427,-74.00597,{"facility":315,"status":8,"city":316,"state":317,"zip":318,"country":138,"contacts":319,"geoPoint":323},"UNC Hospital","Chapel Hill","North Carolina","27514",[320,321],{"name":141,"role":142,"phone":158,"email":144},{"name":322,"role":147},"David Friedlander, MD",{"lat":324,"lon":325},35.9132,-79.05584,[327,329],{"name":141,"role":142,"phone":158,"email":328},"Esekulos@med.umich.edu",{"name":183,"role":142,"phone":184,"email":185},[331],{"name":187,"affiliation":13,"role":147},[333],{"pmid":334,"type":335,"citation":336},"39633425","DERIVED","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\u002Fs13063-024-08587-8.",[],{"nct_id":4,"conditions":339,"biomarkers":342},[340,341],"Nephrolithiasis","Ureterolithiasis",[],{"nct_id":4,"found":15,"summary":344,"prompt_version":354},{"design":345,"status":346,"heading":347,"summary":348,"follow_up":349,"word_count":350,"commitments":351,"compensation":352,"drugs_mentioned":353},"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.","completed","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.","Your pain and healthcare use will be monitored up to 30 days after your ureteroscopy.",137,"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.","Not stated in the trial record.",[],"v2"]