Comparison of Mirabegron and Tamsulosin for Ureteral Stone Expulsion
Recruiting now · Phase 4
Conditions studied: Ureteral Calculi
In brief
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.
Key facts
- Study ID
- NCT07310797
- Run by
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- People needed
- 500
- Starts
- 2026-02-13
- Expected to finish
- 2030-12-31
- Last updated by the study team
- 2026-06-08
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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).
Where it is running
- Taipei Tzu Chi Hospital — New Taipei City, Taiwan (enrolling)
Full record on ClinicalTrials.gov
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