Comparison of Mirabegron and Tamsulosin for Ureteral Stone Expulsion

Buddhist Tzu Chi Medical Foundation

Status and phase: Not yet enrolling; Phase 4

Conditions: Ureteral Calculi

Treatments: Drug: Tamsulosin; Drug: Mirabegron

Study type: Interventional

Funder types: Other

Identifiers

NCT07310797

14-IRB074

TCRD-TPE-115-35 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 4 patient groups

Group A: Mirabegron

Experimental group

Description:

Patients receive Mirabegron 50 mg daily.

Treatment:

Drug: Mirabegron

Group B: Tamsulosin

Active Comparator group

Description:

Patients receive Tamsulosin 0.4 mg daily.

Treatment:

Drug: Tamsulosin

Group C: Combination

Experimental group

Description:

Patients receive Mirabegron 50mg and Tamsulosin 0.4mg daily.

Treatment:

Drug: Mirabegron

Drug: Tamsulosin

Group D: Standard of Care

No Intervention group

Description:

Patients receive standard conservative management (symptomatic control with NSAIDs/analgesics on demand).