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Comparison of Mirabegron and Tamsulosin for Ureteral Stone Expulsion

RecruitingPhase 4Ages 18 Years - 75 YearsAllTaipei Tzu Chi Hospital, Buddhist Tzu Chi Medical…
NCT07310797 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age and Sex: Adult patients aged 18 to 75 years, inclusive of both males and females. 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: 1. Urinary tract infection (UTI). 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).
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What it tests

  • Mirabegron
  • Tamsulosin
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Where

1 site
Taipei Tzu Chi Hospital
New Taipei City, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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