UPURS Trial for Patient-centered Management of Symptomatic Obstructing Stones

Ureteral Stone Clinical Trial

— UPURS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05715086
• Other study ID #: 22-37665
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2023
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: University of California, San Francisco
• Contact: Catherine Arevalo, BA
• Phone: 415-514-0918
• Email: catherine.arevalo[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ureteral Calculi
• Ureteral Stone
• Ureterolithiasis

Intervention

Procedure:
• Ureteroscopy
Upfront ureteroscopy

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Days of work lost	Measured in number of days	3 months
Other	Hospital visits	Measure in number of times	3 months
Primary	Pain Score	Measure on a scale of 1-10, with zero indicating no pain and 10 indicating the worst pain.	3 months
Primary	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	Hospital visit length	Measured in number of days	3 months