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Recruiting NCT05715086

UPURS Trial for Patient-centered Management of Symptomatic Obstructing Stones

No phase Interventional Ureteral Stone

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ureteroscopy.
Who it may be relevant to
Registry conditions: Ureteral Stone. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Procedure Ureteroscopy
    Upfront ureteroscopy

Primary outcome measures

  • Pain Score [Time frame: 3 months]
  • Anxiety Score [Time frame: 3 months]
Secondary outcome measures (1)
  • Hospital visit length [Time frame: 3 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of California, San Francisco — San Francisco

Identifiers

NCT: NCT05715086 · 22-37665

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗