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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
792
Participants will have a stent placed per randomization assigned if there are no complications (per protocol) during ureteroscopy that excludes the participant.
Participants not have a stent placed per randomization assigned if there are no complications (per protocol) during ureteroscopy that excludes the participant.
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.
University of Arizona
Tucson, Arizona, United States
RECRUITINGUF Health Shands Hospital
Gainesville, Florida, United States
RECRUITINGIndiana University Department of Urology
Indianapolis, Indiana, United States
RECRUITINGUniversity of Michigan Health System
Ann Arbor, Michigan, United States
RECRUITINGUniversity of Michigan Health System
Brighton, Michigan, United States
RECRUITINGCadillac Munson Hospital
Cadillac, Michigan, United States
RECRUITINGSt. Joseph Health System Chelsea Hospital
Chelsea, Michigan, United States
RECRUITINGSt. Joseph Mercy Health (Trinity)
Chelsea, Michigan, United States
RECRUITINGHenry Ford Health System
Detroit, Michigan, United States
RECRUITINGCorewell Health Buttersworth Hospital
Grand Rapids, Michigan, United States
RECRUITING...and 6 more locations
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.
Time frame: 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
Time frame: within 30 days after ureteroscopy
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
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.
Time frame: 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.
Time frame: 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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
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
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