A Phase 4 interventional study of Mirabegron and Tamsulosin in Ureteral Calculi, sponsored by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation · Phase 4, Interventional, and Treatment
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.
This study aims to compare the efficacy of Mirabegron, Tamsulosin, their combination, and standard conservative management in facilitating ureteral stone expulsion, as well as to evaluate their impact on clinical symptoms.
The primary objective is to analyze the differences in the stone expulsion rate within four weeks among four treatment groups:
Group A: Mirabegron 50 mg daily.
Group B: Tamsulosin 0.4 mg daily.
Group C: Combination of Mirabegron 50 mg and Tamsulosin 0.4 mg daily.
Group D: Standard of care (symptomatic control). For acute colic, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as Ketorolac or Diclofenac are the first-line treatment. If patients have allergies or contraindications to NSAIDs, alternative analgesics such as Tramadol or Acetaminophen will be administered.
Secondary objectives include comparing the time to stone expulsion, changes in pain intensity (assessed by Visual Analog Scale), consumption of analgesic medication, and the impact of different treatments on patient fatigue (assessed by the Fatigue Symptom Inventory, FSI).
Additionally, the study will collect and analyze adverse events occurring during the treatment period, such as palpitations, blood pressure changes, and headaches, to evaluate the safety of each intervention. The results are expected to provide comprehensive options for Medical Expulsive Therapy (MET), offering alternative non-invasive strategies for patients intolerant to traditional alpha-blockers.
50 studies on the registry are indexed under Ureteral Calculi; 14 are open to participants now.
This study's planned enrollment of 500 is above the median of 100 across 42 interventional studies indexed under Ureteral Calculi.
Browse Ureteral Calculi studies →Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation is the lead sponsor of 58 studies on the registry; 14 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive Mirabegron 50 mg daily.
Drug: Mirabegron
Patients receive Tamsulosin 0.4 mg daily.
Drug: Tamsulosin
Patients receive Mirabegron 50mg and Tamsulosin 0.4mg daily.
Drug: Mirabegron · Drug: Tamsulosin
Patients receive standard conservative management (symptomatic control with NSAIDs/analgesics on demand).
50 mg tablet orally once daily.
0.4 mg tablet orally once daily.
Stone Expulsion Rate
The proportion of participants with complete stone expulsion confirmed by KUB or CT scan. Successful expulsion is defined as the absence of stone fragments or the presence of clinically insignificant fragments.
Time frame: Up to 4 weeks
Time to Stone Expulsion
The number of days from randomization to the confirmation of complete stone expulsion.
Time frame: Up to 4 weeks
Change in Pain Intensity
Assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline and up to 4 weeks
Total Analgesic Consumption
The total amount of analgesic medication (e.g., NSAIDs, Tramadol, Acetaminophen) consumed by the participant to control pain.
Time frame: Up to 4 weeks
Change in Fatigue Symptoms
Assessed using the Fatigue Symptom Inventory (FSI) to measure the intensity and interference of fatigue.
Time frame: Baseline and up to 4 weeks
Incidence of Adverse Events
Number of participants with treatment-related adverse events, such as palpitations, hypotension, dizziness, and headache.
Time frame: Up to 4 weeks
Plan to share: No — Individual participant data will not be shared to protect patient confidentiality. All relevant data will be reported in the final study publication in aggregate form.
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Dec 2029, 46 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Mirabegron · Tamsulosin
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation