UPURS Trial for Patient-centered Management of Symptomatic Obstructing Stones

NCT05715086 | Recruiting

• 1 other identifier: 23-39364
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Ureteral Stone

Keywords

Symptomatic ureteral stones

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Hospital visit length

  3 months

Other Outcomes (2)

• Days of work lost

  3 months

• Hospital visits

  3 months

Study Arms (2)

Group A (Upfront ureteroscopy)

ACTIVE COMPARATOR

Procedure: Ureteroscopy

Group B (Observation/delayed ureteroscopy)

NO INTERVENTION

Interventions

Ureteroscopy PROCEDURE

Upfront ureteroscopy

Group A (Upfront ureteroscopy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presenting to the Emergency Department (ED)
• Adult (\> 18 yo)
• ≥5mm ureteral stone diagnosed on CT scan
• Presence of symptoms (pain, nausea, vomiting, hematuria)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of Colorado, Denver: collaborator

Study Sites (2)

University of California, San Francisco

San Francisco, California, 94143, United States

TERMINATED

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Ureterolithiasis

Interventions

Ureteroscopy

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Heiko Yang, MD

  University of Colorado, Denver

  STUDY CHAIR

Central Study Contacts

Heiko Yang, MD

CONTACT

720-848-1800; HEIKO.YANG@CUANSCHUTZ.EDU

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, non-blinded, randomized controlled trial with two study arms.

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: February 6, 2023
• Study Start: September 6, 2023
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)