Comparison of Mirabegron and Tamsulosin for Ureteral Stone Expulsion

A Randomized Controlled Trial Comparing Mirabegron and Tamsulosin for Ureteral Stone Expulsion and Clinical Symptom Improvement

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ureteral Calculi
• Intervention / Treatment: Drug: Mirabegron; Drug: Tamsulosin

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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Shu-Yu Wu, Doctor of Medicine; Phone Number: 60146 +886-2-6628-9779; Email: nobookrain2014@gmail.com

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 231
    • Taipei Tzu Chi Hospital
    • Contact: Shu-Yu Wu, MD; Phone Number: 60146 +886-2-6628-9779; Email: nobookrain2014@gmail.com
    • Contact: WAN-LING YOUNG, Bachelor of Science in Nursing; Phone Number: 64124 +886-2-6628-9779; Email: lisayoung1345@gmail.com
    • Principal Investigator: Shu-Yu Wu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: Mirabegron; Patients receive Mirabegron 50 mg daily.	Drug: Mirabegron; 50 mg tablet orally once daily.
Active Comparator: Group B: Tamsulosin; Patients receive Tamsulosin 0.4 mg daily.	Drug: Tamsulosin; 0.4 mg tablet orally once daily.
Experimental: Group C: Combination; Patients receive Mirabegron 50mg and Tamsulosin 0.4mg daily.	Drug: Mirabegron; 50 mg tablet orally once daily.; Drug: Tamsulosin; 0.4 mg tablet orally once daily.
No Intervention: Group D: Standard of Care; Patients receive standard conservative management (symptomatic control with NSAIDs/analgesics on demand).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Stone Expulsion	The number of days from randomization to the confirmation of complete stone expulsion.	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).	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.	Up to 4 weeks
Change in Fatigue Symptoms	Assessed using the Fatigue Symptom Inventory (FSI) to measure the intensity and interference of fatigue.	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.	Up to 4 weeks

Collaborators and Investigators

• Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Investigators: Principal Investigator: Shu-Yu Wu, MD, Taichung Tzu Chi Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Mirabegron; Tamsulosin; Medical Expulsive Therapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Ureteral Diseases; Pathological Conditions, Signs and Symptoms; Ureterolithiasis; Ureteral Calculi; Sulfur Compounds; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amides; Benzene Derivatives; Benzenesulfonamides; Sulfonamides; Sulfones; Tamsulosin; mirabegron
• Other Study ID Numbers: 14-IRB074; TCRD-TPE-115-35 (Other Grant/Funding Number: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No