UPURS Trial for Patient-centered Management of Symptomatic Obstructing Stones
Purpose
A prospective, non-blinded, randomized controlled trial studying the management of symptomatic ureteral stones. This study will compare upfront ureteroscopy vs observation and delayed intervention for patients presenting to the emergency department with a symptomatic ureteral stone.
Condition
- Ureteral Stone
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Presenting to the Emergency Department (ED) - Adult (> 18 yo) - ≥5mm ureteral stone diagnosed on CT scan - Presence of symptoms (pain, nausea, vomiting, hematuria)
Exclusion Criteria
- Strict indication for stent - Stone burden not amenable to Ureteroscopy (URS) - Dirty urine analysis (UA) or positive urine culture (UCx) - Transplant kidney - Presence of conduit - Comorbidities not optimized for surgery - Strong preference for surgery or observation
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- A prospective, non-blinded, randomized controlled trial with two study arms.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Group A (Upfront ureteroscopy) |
|
|
|
No Intervention Group B (Observation/delayed ureteroscopy) |
|
Recruiting Locations
San Francisco, California 94143
More Details
- Status
- Recruiting
- Sponsor
- University of California, San Francisco
Detailed Description
Management of symptomatic ureteral stones is variable across the United States due to a lack of clear, patient-centered guidelines. For patients who do not meet criteria for emergent stenting, the decision to recommend upfront definitive treatment (ureteroscopy, ESWL) or medical expulsion therapy is influenced by factors such as practice setting, insurance status, and day of the week. This has resulted in health disparities and delays in care that disproportionately affect vulnerable patient populations. For patients presenting to the emergency department with a symptomatic ureteral stone investigators will randomize into Group A: Upfront Ureteroscopy or Group B: Delayed intervention and observation. Both arms are considered standard of care for patients presenting with the above diagnosis.