search
Back to results

UPURS Trial for Patient-centered Management of Symptomatic Obstructing Stones (UPURS)

Primary Purpose

Ureteral Stone

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ureteroscopy
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ureteral Stone focused on measuring Symptomatic ureteral stones

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group A (Upfront ureteroscopy)

Group B (Observation/delayed ureteroscopy)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hospital visit length
Measured in number of days

Full Information

First Posted
December 16, 2022
Last Updated
February 2, 2023
Sponsor
University of California, San Francisco
search

1. Study Identification

Unique Protocol Identification Number
NCT05715086
Brief Title
UPURS Trial for Patient-centered Management of Symptomatic Obstructing Stones
Acronym
UPURS
Official Title
Upfront vs Postponed Ureteroscopy (UPURS) Trial for Patient-centered Management of Symptomatic Obstructing Stones
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteral Stone
Keywords
Symptomatic ureteral stones

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, non-blinded, randomized controlled trial with two study arms.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A (Upfront ureteroscopy)
Arm Type
Active Comparator
Arm Title
Group B (Observation/delayed ureteroscopy)
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Ureteroscopy
Intervention Description
Upfront ureteroscopy
Primary Outcome Measure Information:
Title
Pain Score
Description
Measure on a scale of 1-10, with zero indicating no pain and 10 indicating the worst pain.
Time Frame
3 months
Title
Anxiety Score
Description
Measure on a scale of 1-10, the score ranges from 0-10, with zero indicating no anxiety and 10 indicating the worst anxiety.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Hospital visit length
Description
Measured in number of days
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Days of work lost
Description
Measured in number of days
Time Frame
3 months
Title
Hospital visits
Description
Measure in number of times
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Arevalo, BA
Phone
415-514-0918
Email
catherine.arevalo@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Heiko Yang, MD
Email
heiko.yang@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Chi, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

UPURS Trial for Patient-centered Management of Symptomatic Obstructing Stones

We'll reach out to this number within 24 hrs