Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative (SOUL MUSIC)
Marcelino Rivera
Primary Investigator
Brief description of study
What is the purpose of this study?
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.
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.
THIS STUDY IS ENROLLING BY INVITATION ONLY
Detailed description of study
What will happen during the study?
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Stone Ureter, Kidney Stone
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Age: 18 years - 100 years
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Gender: All
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.
