Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Standard of care stent placement
- No stent placement
- Surveys
Treatment groups
792 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Michigan
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Michigan Urological Surgery Improvement Collaborative (MUSIC)
Collaborator
Source ClinicalTrials.gov