UPURS Trial for Patient-centered Management of Symptomatic Obstructing Stones

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ureteral Stone

Intervention / Treatment
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* Procedure: Ureteroscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective, non-blinded, randomized controlled trial with two study arms.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A (Upfront ureteroscopy)<br> | Procedure: Ureteroscopy<br>* Upfront ureteroscopy<br>|
| No Intervention: Group B (Observation/delayed ureteroscopy)<br> | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symptomatic ureteral stones