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NCT05715086NARecruitingAccepts Healthy Volunteers

UPURS Trial for Patient-centered Management of Symptomatic Obstructing Stones

University of California, San Francisco

Start Date

8/23/2023

Completion Date

6/30/2026

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.

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

PROCEDURE

Ureteroscopy

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Conditions

Ureteral Stone

Locations

University of California, San Francisco

San Francisco, California 94143

United States