Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative

Study Overview
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Brief Summary
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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
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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.

Official Title
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Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative (SOUL MUSIC)

Conditions
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Stone, Kidney, Stone Ureter

Intervention / Treatment
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* Device: Standard of care stent placement
* Other: No stent placement
* Other: Surveys


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Randomized cohort- No stent placement<br>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. | Other: No stent placement<br>* Participants not have a stent placed per randomization assigned if there are no complications (per protocol) during ureteroscopy that excludes the participant.<br>Other: Surveys<br>* 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.<br>|
| Experimental: Randomized cohort- Stent placement<br>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. | Device: Standard of care stent placement<br>* Participants will have a stent placed per randomization assigned if there are no complications (per protocol) during ureteroscopy that excludes the participant.<br>Other: Surveys<br>* 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.<br>|
| Other: Observational participants - not randomized<br>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. | Other: Surveys<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | within 30 days after ureteroscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Intensive Care Unit care during unplanned hospital admission within postoperative day 30 |  | within 30 days after ureteroscopy | 
| Number of Participants with Unplanned hospital admission within postoperative day 30 |  | within 30 days after ureteroscopy | 
| Number of Participants with Unplanned additional procedure related to ureteroscopy within postoperative day 30 |  | 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 |  | within 30 days after ureteroscopy | 
| Unplanned ambulatory urology office visit and/or diagnostic testing (urine testing and/or imaging) within postoperative day 30 |  | within 30 days after ureteroscopy | 
| Number of ambulatory patient-provider interactions: phone calls / EMR messages within postoperative day 30 |  | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Postoperative 4-6 weeks | 
| Number of days taken off work by patients and caregivers during the first 7 days after ureteroscopy |  | First 7 days after ureteroscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unilateral ureteroscopy and lithotripsy, Ureteral stent, Pain assessment, Quality of life