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UPURS Trial for Patient-centered Management of Symptomatic Obstructing Stones

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05715086
Acronym
UPURS
Enrollment
100
Registered
2023-02-06
Start date
2023-09-06
Completion date
2030-12-31
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ureteral Stone

Keywords

Symptomatic ureteral stones

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.

Interventions

PROCEDUREUreteroscopy

Upfront ureteroscopy

Sponsors

University of California, San Francisco
Lead SponsorOTHER
University of Colorado, Denver
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

A prospective, non-blinded, randomized controlled trial with two study arms.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain Score3 monthsMeasure on a scale of 1-10, with zero indicating no pain and 10 indicating the worst pain.
Anxiety Score3 monthsMeasure on a scale of 1-10, the score ranges from 0-10, with zero indicating no anxiety and 10 indicating the worst anxiety.

Secondary

MeasureTime frameDescription
Hospital visit length3 monthsMeasured in number of days

Countries

United States

Contacts

CONTACTHeiko Yang, MD
HEIKO.YANG@CUANSCHUTZ.EDU720-848-1800
STUDY_CHAIRHeiko Yang, MD

University of Colorado, Denver

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026