UPURS Trial for Patient-centered Management of Symptomatic Obstructing Stones
ConditionUreteral Stone
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Presenting to the Emergency Department (ED)
Adult (> 18 yo)
≥5mm ureteral stone diagnosed on CT scan
Presence of symptoms (pain, nausea, vomiting, hematuria)
Disqualifiers
Strict indication for stent
Stone burden not amenable to Ureteroscopy (URS)
Dirty urine analysis (UA) or positive urine culture (UCx)
Transplant kidney
Trial design
Design model
Parallel
Treatments tested in this trial
Ureteroscopy
Procedure/SurgeryUpfront ureteroscopy
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Group A (Upfront ureteroscopy)Active comparator 1 intervention
Group B: Group B (Observation/delayed ureteroscopy)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Pain Score
Measure on a scale of 1-10, with zero indicating no pain and 10 indicating the worst pain.
Time frame
3 months2
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.
Time frame
3 monthsSecondary outcomes
1
Hospital visit length
Measured in number of days
Time frame
3 monthsOther outcomes
1
Days of work lost
Measured in number of days
Time frame
3 months2
Hospital visits
Measure in number of times
Time frame
3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
University of Colorado, Denver
Collaborator
Source ClinicalTrials.gov