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| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
| State University of New York - Upstate Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Upfront ureteroscopy) | Active Comparator |
| |
| Group B (Observation/delayed ureteroscopy) | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ureteroscopy | Procedure | Upfront ureteroscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital visit length | Measured in number of days | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Days of work lost | Measured in number of days | 3 months |
| Hospital visits | Measure in number of times | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catherine Arevalo, BA | Contact | 415-514-0918 | catherine.arevalo@ucsf.edu | |
| Heiko Yang, MD | Contact | heiko.yang@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Chi, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94143 | United States |
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| ID | Term |
|---|---|
| D053039 | Ureterolithiasis |
| ID | Term |
|---|---|
| D014515 | Ureteral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D018666 | Ureteroscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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A prospective, non-blinded, randomized controlled trial with two study arms.
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| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |
| D003950 | Diagnostic Techniques, Urological |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |