NCT03043612已完成不适用
Cook Ureteral Stent Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Patient-reported body pain score
研究概览
简要总结
The purpose of this study is to evaluate the feasibility of the Cook Ureteral Stent to reduce post-stent placement pain and urinary symptoms in patients following ureteroscopy for urolithiasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is undergoing ureteroscopy for urolithiasis in which temporary ureteral stenting is indicated
排除标准
- •Patient is unwilling or unable to sign and date the informed consent
- •Patient is unwilling to comply with the follow-up study schedule
- •Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study
- •Patient is currently taking anti-cholinergic or other anti-spasm medications
- •Patient is currently taking sildenafil, tadalafil, or vardenafil
- •Patient has a known sensitivity to alpha-blocker medications
- •Patient is currently undergoing chemotherapy or radiation therapy
- •Patient has an active urinary tract infection
- •Patient is in chronic renal failure, on hemodialysis, or on chronic peritoneal dialysis
- •Patient requires bilateral shock wave lithotripsy, bilateral stents, or has bilateral symptomatic kidney stones
- •Patient has had a ureteral stent within the past three months in either ureter
- •Patient is unable to accurately detect or report bladder function or pain
- •Patient has chronic pain
结局指标
主要结局
Patient-reported body pain score
时间窗: 7-days post stent placement
Comparing the patient-reported body pain score from the USSQ 1 survey between the two study arms
次要结局
未报告次要终点
研究者
研究点 (2)
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