UPURS Trial for Patient-centered Management of Symptomatic Obstructing Stones (UPURS)

Upfront vs Postponed Ureteroscopy (UPURS) Trial for Patient-centered Management of Symptomatic Obstructing Stones

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.

Study Overview

• Status: Recruiting
• Conditions: Ureteral Stone
• Intervention / Treatment: Procedure: Ureteroscopy

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine Arevalo, BA; Phone Number: 415-514-0918; Email: catherine.arevalo@ucsf.edu
• Study Contact Backup: Name: Heiko Yang, MD; Email: heiko.yang@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California, San Francisco
      • Contact: Tom Chi, MD; Email: tom.chi@ucsf.edu
      • Contact: Heiko Yang, MD; Phone Number: 513-8862172; Email: heiko.yang@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A (Upfront ureteroscopy)	Procedure: Ureteroscopy; Upfront ureteroscopy
No Intervention: Group B (Observation/delayed ureteroscopy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score	Measure on a scale of 1-10, with zero indicating no pain and 10 indicating the worst pain.	3 months
Anxiety Score	Measure on a scale of 1-10, the score ranges from 0-10, with zero indicating no anxiety and 10 indicating the worst anxiety.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital visit length	Measured in number of days	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days of work lost	Measured in number of days	3 months
Hospital visits	Measure in number of times	3 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: University of Colorado, Denver; State University of New York - Upstate Medical University
• Investigators: Principal Investigator: Thomas Chi, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 16, 2022
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Symptomatic ureteral stones
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Ureteral Diseases; Ureteral Calculi; Ureterolithiasis
• Other Study ID Numbers: 22-37665

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No