A Randomized Controlled Trial Comparing Mirabegron and Tamsulosin for Ureteral Stone Expulsion and Clinical Symptom Improvement
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Stone Expulsion Rate
研究概览
简要总结
This randomized controlled trial compares the efficacy and safety of four treatment strategies for ureteral stone expulsion: Mirabegron alone, Tamsulosin alone, a combination of both, and standard conservative care. Participants diagnosed with ureteral stones will be randomly assigned to one of these four groups. The primary objective is to evaluate the stone expulsion rate within 4 weeks. The study also assesses time to expulsion, pain intensity, analgesic use, and potential side effects.
详细描述
This study aims to compare the efficacy of Mirabegron, Tamsulosin, their combination, and standard conservative management in facilitating ureteral stone expulsion, as well as to evaluate their impact on clinical symptoms.
The primary objective is to analyze the differences in the stone expulsion rate within four weeks among four treatment groups:
Group A: Mirabegron 50 mg daily.
Group B: Tamsulosin 0.4 mg daily.
Group C: Combination of Mirabegron 50 mg and Tamsulosin 0.4 mg daily.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age and Sex: Adult patients aged 18 to 75 years, inclusive of both males and females.
- •Diagnosis: Unilateral ureteral stone confirmed by Computed Tomography (CT), Renal Sonography, or Kidney-Ureter-Bladder (KUB) radiography.
- •Stone Characteristics: Stone size between 4 mm and 10 mm; located in the upper (proximal), middle, or lower (distal) ureter.
- •Symptoms and Renal Function: Presence of renal colic or hematuria, with no severe renal insufficiency (eGFR > 60 mL/min/1.73m²).
排除标准
- •Urinary tract infection (UTI).
- •Multiple or bilateral ureteral stones.
- •Ureteral stones not visible on KUB radiography (radiolucent stones).
- •Pregnant or lactating women.
- •Severe hydronephrosis.
- •Renal insufficiency (defined as eGFR < 30 mL/min/1.73m² or Serum Creatinine > 2 mg/dL).
- •Uncontrolled hypertension or major cardiovascular disease.
- •Patients who refuse Medical Expulsive Therapy (MET).
研究组 & 干预措施
Group A: Mirabegron
Patients receive Mirabegron 50 mg daily.
干预措施: Mirabegron (Drug)
Group B: Tamsulosin
Patients receive Tamsulosin 0.4 mg daily.
干预措施: Tamsulosin (Drug)
Group C: Combination
Patients receive Mirabegron 50mg and Tamsulosin 0.4mg daily.
干预措施: Mirabegron (Drug)
Group C: Combination
Patients receive Mirabegron 50mg and Tamsulosin 0.4mg daily.
干预措施: Tamsulosin (Drug)
结局指标
主要结局
Stone Expulsion Rate
时间窗: Up to 4 weeks
The proportion of participants with complete stone expulsion confirmed by KUB or CT scan. Successful expulsion is defined as the absence of stone fragments or the presence of clinically insignificant fragments.
次要结局
- Change in Pain Intensity(Baseline and up to 4 weeks)
- Total Analgesic Consumption(Up to 4 weeks)
- Change in Fatigue Symptoms(Baseline and up to 4 weeks)
- Time to Stone Expulsion(Up to 4 weeks)
- Incidence of Adverse Events(Up to 4 weeks)
研究者
Shu-Yu Wu
Attending Physician
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation