米拉贝隆与坦索罗辛促进输尿管结石排出的比较
一项比较米拉贝隆与坦索罗辛用于输尿管结石排出及临床症状改善的随机对照试验
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.
研究概览
详细说明
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.
Group D: Standard of care (symptomatic control). For acute colic, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as Ketorolac or Diclofenac are the first-line treatment. If patients have allergies or contraindications to NSAIDs, alternative analgesics such as Tramadol or Acetaminophen will be administered.
Secondary objectives include comparing the time to stone expulsion, changes in pain intensity (assessed by Visual Analog Scale), consumption of analgesic medication, and the impact of different treatments on patient fatigue (assessed by the Fatigue Symptom Inventory, FSI).
Additionally, the study will collect and analyze adverse events occurring during the treatment period, such as palpitations, blood pressure changes, and headaches, to evaluate the safety of each intervention. The results are expected to provide comprehensive options for Medical Expulsive Therapy (MET), offering alternative non-invasive strategies for patients intolerant to traditional alpha-blockers.
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名：Shu-Yu Wu, Doctor of Medicine
- 电话号码：60146 +886-2-6628-9779
- 邮箱：nobookrain2014@gmail.com
学习地点
-
-
-
New Taipei City、台湾、231
- 招聘中
- Taipei Tzu Chi Hospital
-
接触：
- Shu-Yu Wu, MD
- 电话号码：60146 +886-2-6628-9779
- 邮箱：nobookrain2014@gmail.com
-
接触：
- WAN-LING YOUNG, Bachelor of Science in Nursing
- 电话号码：64124 +886-2-6628-9779
- 邮箱：lisayoung1345@gmail.com
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首席研究员：
- Shu-Yu Wu, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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).
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Group A: Mirabegron
Patients receive Mirabegron 50 mg daily. |
50 mg tablet orally once daily. |
|
有源比较器：Group B: Tamsulosin
Patients receive Tamsulosin 0.4 mg daily. |
0.4 mg tablet orally once daily. |
|
实验性的：Group C: Combination
Patients receive Mirabegron 50mg and Tamsulosin 0.4mg daily. |
50 mg tablet orally once daily. 0.4 mg tablet orally once daily. |
|
无干预：Group D: Standard of Care
Patients receive standard conservative management (symptomatic control with NSAIDs/analgesics on demand). |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Stone Expulsion Rate
大体时间：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. |
Up to 4 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to Stone Expulsion
大体时间：Up to 4 weeks
|
The number of days from randomization to the confirmation of complete stone expulsion. |
Up to 4 weeks
|
|
Change in Pain Intensity
大体时间：Baseline and up to 4 weeks
|
Assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). |
Baseline and up to 4 weeks
|
|
Total Analgesic Consumption
大体时间：Up to 4 weeks
|
The total amount of analgesic medication (e.g., NSAIDs, Tramadol, Acetaminophen) consumed by the participant to control pain. |
Up to 4 weeks
|
|
Change in Fatigue Symptoms
大体时间：Baseline and up to 4 weeks
|
Assessed using the Fatigue Symptom Inventory (FSI) to measure the intensity and interference of fatigue. |
Baseline and up to 4 weeks
|
|
Incidence of Adverse Events
大体时间：Up to 4 weeks
|
Number of participants with treatment-related adverse events, such as palpitations, hypotension, dizziness, and headache. |
Up to 4 weeks
|
合作者和调查者
调查人员
- 首席研究员：Shu-Yu Wu, MD、Taichung Tzu Chi Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 14-IRB074
- TCRD-TPE-115-35 (其他赠款/资助编号：Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Individual participant data will not be shared to protect patient confidentiality. All relevant data will be reported in the final study publication in aggregate form.
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