Mirabegron vs. Tamsulosin for ureteral stone expulsion
Official title: A Randomized Controlled Trial Comparing Mirabegron and Tamsulosin for Ureteral Stone Expulsion and Clinical Symptom Improvement
Run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation · NCT07310797 · Data updated 2026-11-12
This trial tests four approaches—Mirabegron alone, Tamsulosin alone, both together, or standard care—to help adults with a ureteral stone pass the stone within about a month.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation Academic / other |
| Locations | 1 site (New Taipei City) |
| Status | Recruiting |
| Started | February 13, 2026 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2030 |
| Registry record updated | October 1, 2026 |
| Trial ID | NCT07310797 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with a radiographically confirmed unilateral ureteral stone 4–10 mm, in any ureter segment, and no major renal impairment or exclusionary conditions.
✕Probably not a fit
Patients with factors like active infection, severe hydronephrosis, renal impairment, pregnancy, or other exclusion criteria may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, four-arm study compares Mirabegron, Tamsulosin, their combination, and standard conservative care for promoting ureteral stone expulsion. Participants with stones 4–10 mm in various ureteral locations will be assigned to one of the four strategies and followed for four weeks to measure stone expulsion rate, time to expulsion, pain, analgesic use, and safety. Secondary outcomes include changes in pain scores, fatigue, and adverse events such as palpitations or blood pressure changes. The trial aims to identify non-invasive Medical Expulsive Therapy options for patients who may not tolerate traditional alpha-blockers.
Why it matters
Potential benefit: If successful, the study could expand non-invasive options to help more patients pass ureteral stones without surgery.
How similar studies have gone: Prior studies have explored MET options; this trial adds a direct comparison of Mirabegron and Tamsulosin, including their combination, which is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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).
Where it's running
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Taipei Tzu Chi Hospital
New Taipei City, Taiwan Recruiting
Study contacts
- Principal investigator: Shu-Yu Wu, MD — Taichung Tzu Chi Hospital
- Study coordinator: Shu-Yu Wu, Doctor of Medicine
- Email: nobookrain2014@gmail.com
- Phone: +886-2-6628-9779
Similar studies
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L-Citrulline vs Tamsulosin for Helping Distal Ureteral Stones Pass
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.