UPURS Trial for Patient-centered Management of Symptomatic Obstructing Stones

Not Applicable

Recruiting

• Conditions: Ureteral Stone
• Interventions: Procedure: Ureteroscopy

• Registration Number: NCT05715086
• Lead Sponsor: University of California, San Francisco

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.

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 Timeline

• Study First Submitted: 2022-12-16
• Study First Submitted QC: 2023-02-02
• Study First Posted: 2023-02-06
• Study Start: 2023-08-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (Upfront ureteroscopy)	Ureteroscopy	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Hospital visit length	3 months	Measured in number of days

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States