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)
University of Michigan
792 participants
Jun 1, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria16
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
Locations(16)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05866081