Ureteral Calculi
Conditions
Keywords
Mirabegron, Tamsulosin, Medical Expulsive Therapy
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.
Detailed description
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.
Interventions
DRUGMirabegron
50 mg tablet orally once daily.
DRUGTamsulosin
0.4 mg tablet orally once daily.
Sponsors
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are randomly assigned to one of four parallel treatment groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone Expulsion Rate | Up to 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Stone Expulsion | Up to 4 weeks | The number of days from randomization to the confirmation of complete stone expulsion. |
| Change in Pain Intensity | Baseline and up to 4 weeks | Assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). |
| Total Analgesic Consumption | Up to 4 weeks | The total amount of analgesic medication (e.g., NSAIDs, Tramadol, Acetaminophen) consumed by the participant to control pain. |
| Change in Fatigue Symptoms | Baseline and up to 4 weeks | Assessed using the Fatigue Symptom Inventory (FSI) to measure the intensity and interference of fatigue. |
| Incidence of Adverse Events | Up to 4 weeks | Number of participants with treatment-related adverse events, such as palpitations, hypotension, dizziness, and headache. |
Countries
Taiwan
Contacts
CONTACTShu-Yu Wu, Doctor of Medicine
PRINCIPAL_INVESTIGATORShu-Yu Wu, MD
Taichung Tzu Chi Hospital
Outcome results
None listed