UPURS Trial for Patient-centered Management of Symptomatic Obstructing Stones
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group A (Upfront ureteroscopy)
|
Procedure: Ureteroscopy
Upfront ureteroscopy
|
| No Intervention: Group B (Observation/delayed ureteroscopy)
|
Outcome Measures
Primary Outcome Measures
- Pain Score [3 months]
Measure on a scale of 1-10, with zero indicating no pain and 10 indicating the worst pain.
- Anxiety Score [3 months]
Measure on a scale of 1-10, the score ranges from 0-10, with zero indicating no anxiety and 10 indicating the worst anxiety.
Secondary Outcome Measures
- Hospital visit length [3 months]
Measured in number of days
Other Outcome Measures
- Days of work lost [3 months]
Measured in number of days
- Hospital visits [3 months]
Measure in number of times
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, San Francisco | San Francisco | California | United States | 94143 |
Sponsors and Collaborators
- University of California, San Francisco
Investigators
- Principal Investigator: Thomas Chi, MD, University of California, San Francisco
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-37665