NCT00467467已完成3 期
Alfuzosin Hydrochloride to Relieve Ureteral Stent Discomfort
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- effect of study medication on urinary symptoms and quality of life
研究概览
简要总结
To assess the impact of alfuzosin vs. placebo on ureteral stent discomfort, urinary symptoms and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Double
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
- •Undergoing unilateral retrograde ureteroscopy with ureteral stent placement
排除标准
- •Significant ureteral trauma
- •Concomitant ESWL or other secondary surgical procedure than may impact patient comfort
- •Subject with know hypersensitivity to alfuzosin hydrochloride or any component of alfuzosin hydrochloride tablets.
- •Pregnancy, nursing mother, or woman of child-bearing age unwilling to take contraception for the duration of the study
- •Undergoing bilateral ureteral stenting
- •Undergoing antegrade ureteral stenting
- •Undergoing simultaneous extracorporeal shockwave lithotripsy
- •Urinary infection (fever >101, positive urine culture, many bacteria on urinalysis)
- •Primary bladder dysfunction that would impact ability to void without a catheter
- •Neurologic dysfunction that would impair pain sensation
- •History of chronic pain or substance abuse
- •Potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased
- •Other alpha-blockers
- •Phosphodiesterase type 5 inhibitors for erectile function Any subject for whom the principal investigator feels it would not be in his or her best interest to participate in the study.
结局指标
主要结局
effect of study medication on urinary symptoms and quality of life
usage of analgesics/narcotics
次要结局
未报告次要终点
研究者
研究点 (2)
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