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RECRUITING Phase 4 ClinicalTrials.gov

Comparison of Mirabegron and Tamsulosin for Ureteral Stone Expulsion

Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation • ClinicalTrials.gov ID: NCT07310797

Registry updated: 2026-10-01
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Description

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.

Interventions

  • Mirabegron (Drug)
    50 mg tablet orally once daily.
  • Tamsulosin (Drug)
    0.4 mg tablet orally once daily.

Eligibility criteria

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).

Conditions

Ureteral Calculi

Locations

  • Taipei Tzu Chi Hospital — New Taipei City, Taiwan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record