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NCT Number: NCT05715086

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ureteroscopy

Procedure

Upfront ureteroscopy

Primary outcomes

  1. Pain Score

    Time frame: 3 months

    Measure on a scale of 1-10, with zero indicating no pain and 10 indicating the worst pain.

  2. Anxiety Score

    Time frame: 3 months

    Measure on a scale of 1-10, the score ranges from 0-10, with zero indicating no anxiety and 10 indicating the worst anxiety.

Secondary outcomes

  1. Hospital visit length

    Time frame: 3 months

    Measured in number of days

Other outcomes

  1. Days of work lost

    Time frame: 3 months

    Measured in number of days

  2. Hospital visits

    Time frame: 3 months

    Measure in number of times

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Arevalo, BA

CONTACT

[email protected]

415-514-0918

Heiko Yang, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • State University of New York - Upstate Medical University
  • University of Colorado, Denver

Registry information

Official study title

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

Acronym: UPURS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2023
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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