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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
50 mg tablet orally once daily.
0.4 mg tablet orally once daily.
Taipei Tzu Chi Hospital
New Taipei City, Taiwan
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
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Enrollment
500