NCT07310797 Comparison of Mirabegron and Tamsulosin for Ureteral Stone Expulsion
| NCT ID | NCT07310797 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation |
| Condition | Ureteral Calculi |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2026-02-13 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 500 participants in total. It began in 2026-02-13 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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).
Contact & Investigator
Shu-Yu Wu, MD
PRINCIPAL INVESTIGATOR
Taichung Tzu Chi Hospital
Frequently Asked Questions
Who can join the NCT07310797 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Ureteral Calculi. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07310797 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07310797 currently recruiting?
Yes, NCT07310797 is actively recruiting participants. Contact the research team at nobookrain2014@gmail.com for enrollment information.
Where is the NCT07310797 trial being conducted?
This trial is being conducted at New Taipei City, Taiwan.
Who is sponsoring the NCT07310797 clinical trial?
NCT07310797 is sponsored by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation. The principal investigator is Shu-Yu Wu, MD at Taichung Tzu Chi Hospital. The trial plans to enroll 500 participants.