Stone, Kidney, Stone Ureter
Conditions
Keywords
Unilateral ureteroscopy and lithotripsy, Ureteral stent, Pain assessment, Quality of life
Brief 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. 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.
Interventions
DEVICEStandard 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.
OTHERNo stent placement
Participants not have a stent placed per randomization assigned if there are no complications (per protocol) during ureteroscopy that excludes the participant.
OTHERSurveys
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.
Sponsors
Patient-Centered Outcomes Research Institute
Michigan Urological Surgery Improvement Collaborative (MUSIC)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
Surgeons will remain blinded to this allocation until the surgeon has confirmed secondary eligibility.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes Measurement Information System (PROMIS®) Pain Interference (Short Form 6b) change at Postoperative Day 7-10 compared to preoperative | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| PROMIS® Pain Interference (Short Form 6b) change at postoperative 4-6 weeks compared to preoperative | preoperative, 4-6 weeks | 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. |
| PROMIS® Pain Intensity (Short Form 3a) change at postoperative day 7-10 preoperative | preoperative, postoperative day 7-10 | 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. |
| Number of ambulatory patient-provider interactions: phone calls / EMR messages within postoperative day 30 | within 30 days after ureteroscopy | — |
| 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 | preoperative, postoperative day 7-10 | 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. |
| 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 | preoperative, postoperative 4-6 weeks | 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. |
| International Consultation on Incontinence - Satisfaction (ICIQ-S) treatment satisfaction scores at postoperative day 7-10 | 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. |
| International Consultation on Incontinence - Satisfaction (ICIQ-S) treatment satisfaction scores at postoperative 4-6 weeks | 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. |
| Number of days taken off work by patients and caregivers during the first 7 days after ureteroscopy | First 7 days after ureteroscopy | — |
| PROMIS® Pain Intensity (Short Form 3a) change at postoperative 4-6 weeks compared to preoperative | preoperative, postoperative 4-6 weeks | 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. |
| Number of Participants with Intensive Care Unit care during unplanned hospital admission within postoperative day 30 | within 30 days after ureteroscopy | — |
Countries
United States
Contacts
Primary ContactElaina Shoemaker
Backup ContactSabrina Clark
Outcome results
None listed