Evaluation of Alfuzosin as Medical Expulsion Therapy for Ureteral Stones
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- The primary measures are percent of stones passed and rates of occurrence of various side effects (categorical variables), and time to pass, pain scale, and amount of pain medication taken (continuous variables).
研究概览
简要总结
The goal of this study is to conduct a prospective controlled trail of four currently approved Department of Defense (DOD) - formulary medications for use as medical expulsion therapy (MET) for kidney stones. Between 8% and 15% of Americans will develop symptomatic urolithiasis in there life. Several medications, including steroids, calcium channel blockers, alpha-adrenergic antagonists and non-steroidal anti-inflammatory drugs, have been utilized to aid in the spontaneous passage of distal ureteral calculi. Recently, use of selective alpha-blockers has shown promise for medical expulsion therapy (MET) of distal ureteral calculi. None of these studies have been widely publicized outside the specialty of urology. Recent studies have shown a success rate of nearly 90% when the selective alpha-blocker tamsulosin (Flomax) was used for MET. MET has also been shown to result in a decreased narcotic requirement, shorter time to stone passage, and reduced requirement for further interventions. The investigators will evaluate the effectiveness of MET as initial management for kidney stones using DOD-approved formulary medications.
详细描述
Patients presenting to Naval Medical Center San Diego with symptomatic ureteral stones visible on CT and KUB, and who are medically stable will be offered enrollment. Upon consent, patients will be randomly assigned to one of four outpatient treatment arms, randomized 1:1:1:1 and include; Group 1 - Alfuzosin 10 mg daily, Group 2 - Nifedipine 30 mg daily, Group 3 - Doxazosin 4 mg daily, or Group 4 - Prazosin 1 mg twice daily. The primary endpoint is stone expulsion rate and secondary endpoints are time to expulsion, need for additional intervention, degree of pain control, amount of narcotic use, and evaluation of study drug side effects. The treatment regimens consist of daily medication until the stone passes or 21 days, whatever is shorter. Patients will also receive oral pain medication as needed.
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
- •Age >/= 18 years
- •Single ureteral stone < 1 cm in greatest dimension
排除标准
- •Age < 18 years
- •Active unstable angina
- •History of or active postural hypotension (>20 mmHg drop in orthostatic SBP)
- •Allergy to alpha-blockers
- •Acute or Chronic Renal Failure as demonstrated by a serum creatinine of > 1.4 mg/dl
- •Urinary tract infection
- •Multiple ureteral stones
- •Current uncontrolled diabetes
- •Alpha-blocker therapy within 30 days for any reason
- •Current pregnancy or lactation
- •Patient desire for immediate stone removal
研究组 & 干预措施
1
Alfuzosin 10mg daily
干预措施: Alfuzosin (Drug)
2
Nifedipine XL 30mg daily
干预措施: nifedipine (Drug)
3
Doxazosin 4 mg daily
干预措施: doxazosin (Drug)
4
Prazosin 1 mg BID
干预措施: prazosin (Drug)
结局指标
主要结局
The primary measures are percent of stones passed and rates of occurrence of various side effects (categorical variables), and time to pass, pain scale, and amount of pain medication taken (continuous variables).
时间窗: Period of stone passage (30 days)
次要结局
未报告次要终点
研究者
Sean Stroup
Principle Investigator
United States Naval Medical Center, San Diego