Upfront vs Postponed Ureteroscopy (UPURS) Trial for Patient-centered Management of Symptomatic Obstructing Stones
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Pain Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presenting to the Emergency Department (ED)
- •Adult (> 18 yo)
- •≥5mm ureteral stone diagnosed on CT scan
- •Presence of symptoms (pain, nausea, vomiting, hematuria)
排除标准
- •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
研究组 & 干预措施
Group A (Upfront ureteroscopy)
干预措施: Ureteroscopy (Procedure)
Group B (Observation/delayed ureteroscopy)
结局指标
主要结局
Pain Score
时间窗: 3 months
Measure on a scale of 1-10, with zero indicating no pain and 10 indicating the worst pain.
Anxiety Score
时间窗: 3 months
Measure on a scale of 1-10, the score ranges from 0-10, with zero indicating no anxiety and 10 indicating the worst anxiety.
次要结局
- Hospital visit length(3 months)
