UPURS Trial for Patient-centered Management of Symptomatic Obstructing Stones

NCT ID: NCT05715086

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-23
• Study Completion Date: 2026-06-30

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.

Conditions

Ureteral Stone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A (Upfront ureteroscopy)

Group Type: ACTIVE_COMPARATOR

Ureteroscopy

Intervention Type: PROCEDURE

Upfront ureteroscopy

Group B (Observation/delayed ureteroscopy)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ureteroscopy

Upfront ureteroscopy

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

State University of New York - Upstate Medical University

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Chi, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Catherine Arevalo, BA

Role: CONTACT

catherine.arevalo@ucsf.edu

415-514-0918

Heiko Yang, MD

Role: CONTACT

heiko.yang@ucsf.edu

Facility Contacts

Tom Chi, MD

Role: primary

tom.chi@ucsf.edu

Heiko Yang, MD

Role: backup

heiko.yang@ucsf.edu

513-8862172

Other Identifiers

22-37665

Identifier Type: -

Identifier Source: org_study_id