Comparison of Mirabegron and Tamsulosin for Ureteral Stone Expulsion
NCT ID: NCT07310797
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
500 participants
INTERVENTIONAL
2026-01-01
2030-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A: Mirabegron
Patients receive Mirabegron 50 mg daily.
Mirabegron
50 mg tablet orally once daily.
Group B: Tamsulosin
Patients receive Tamsulosin 0.4 mg daily.
Tamsulosin
0.4 mg tablet orally once daily.
Group C: Combination
Patients receive Mirabegron 50mg and Tamsulosin 0.4mg daily.
Mirabegron
50 mg tablet orally once daily.
Tamsulosin
0.4 mg tablet orally once daily.
Group D: Standard of Care
Patients receive standard conservative management (symptomatic control with NSAIDs/analgesics on demand).
No interventions assigned to this group
Interventions
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Mirabegron
50 mg tablet orally once daily.
Tamsulosin
0.4 mg tablet orally once daily.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis: Unilateral ureteral stone confirmed by Computed Tomography (CT), Renal Sonography, or Kidney-Ureter-Bladder (KUB) radiography.
3. Stone Characteristics: Stone size between 4 mm and 10 mm; located in the upper (proximal), middle, or lower (distal) ureter.
4. Symptoms and Renal Function: Presence of renal colic or hematuria, with no severe renal insufficiency (eGFR \> 60 mL/min/1.73m²).
Exclusion Criteria
2. Multiple or bilateral ureteral stones.
3. Ureteral stones not visible on KUB radiography (radiolucent stones).
4. Pregnant or lactating women.
5. Severe hydronephrosis.
6. Renal insufficiency (defined as eGFR \< 30 mL/min/1.73m² or Serum Creatinine \> 2 mg/dL).
7. Uncontrolled hypertension or major cardiovascular disease.
8. Patients who refuse Medical Expulsive Therapy (MET).
18 Years
75 Years
ALL
No
Sponsors
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Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
OTHER
Responsible Party
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Shu-Yu Wu
Attending Physician
Principal Investigators
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Shu-Yu Wu, MD
Role: PRINCIPAL_INVESTIGATOR
Taichung Tzu Chi Hospital
Locations
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Taipei Tzu Chi Hospital
New Taipei City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Shu-Yu Wu, MD
Role: primary
WAN-LING YOUNG, Bachelor of Science in Nursing
Role: backup
Other Identifiers
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TCRD-TPE-115-35
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
14-IRB074
Identifier Type: -
Identifier Source: org_study_id