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| ID | Type | Description | Link |
|---|---|---|---|
| TCRD-TPE-115-35 | Other Grant/Funding Number | Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Mirabegron | Experimental | Patients receive Mirabegron 50 mg daily. |
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| Group B: Tamsulosin | Active Comparator | Patients receive Tamsulosin 0.4 mg daily. |
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| Group C: Combination | Experimental | Patients receive Mirabegron 50mg and Tamsulosin 0.4mg daily. |
|
| Group D: Standard of Care | No Intervention | Patients receive standard conservative management (symptomatic control with NSAIDs/analgesics on demand). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirabegron | Drug | 50 mg tablet orally once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stone Expulsion Rate | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Stone Expulsion | The number of days from randomization to the confirmation of complete stone expulsion. | Up to 4 weeks |
| Change in Pain Intensity | Assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shu-Yu Wu, Doctor of Medicine | Contact | +886-2-6628-9779 | 60146 | nobookrain2014@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shu-Yu Wu, MD | Taichung Tzu Chi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Tzu Chi Hospital | Recruiting | New Taipei City | 231 | Taiwan |
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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| ID | Term |
|---|---|
| D014514 | Ureteral Calculi |
| ID | Term |
|---|---|
| D053039 | Ureterolithiasis |
| D014515 | Ureteral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C520025 | mirabegron |
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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Participants are randomly assigned to one of four parallel treatment groups.
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| Tamsulosin | Drug | 0.4 mg tablet orally once daily. |
|
| Baseline and up to 4 weeks |
| Total Analgesic Consumption | 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 | 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 | Number of participants with treatment-related adverse events, such as palpitations, hypotension, dizziness, and headache. | Up to 4 weeks |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |