UPURS Trial for Patient-centered Management of Symptomatic Obstructing Stones

NCT05715086 | Recruiting

• 1 other identifier: 22-37665
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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
• State University of New York - Upstate Medical University: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, 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

• Thomas Chi, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Arevalo, BA

CONTACT

415-514-0918; catherine.arevalo@ucsf.edu

Heiko Yang, MD

CONTACT

heiko.yang@ucsf.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: August 23, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)