Comparison of Mirabegron and Tamsulosin for Ureteral Stone Expulsion

NCT07310797 | Not Yet Recruiting Phase 4

• 2 other identifiers: 14-IRB074TCRD-TPE-115-35
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Ureteral Calculi

Keywords

Mirabegron; Tamsulosin; Medical Expulsive Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time to Stone Expulsion

  Up to 4 weeks

• Change in Pain Intensity

  Baseline and up to 4 weeks

• Total Analgesic Consumption

  Up to 4 weeks

• Change in Fatigue Symptoms

  Baseline and up to 4 weeks

• Incidence of Adverse Events

  Up to 4 weeks

Study Arms (4)

Group A: Mirabegron

EXPERIMENTAL

Patients receive Mirabegron 50 mg daily.

Drug: Mirabegron

Group B: Tamsulosin

ACTIVE COMPARATOR

Patients receive Tamsulosin 0.4 mg daily.

Drug: Tamsulosin

Group C: Combination

EXPERIMENTAL

Patients receive Mirabegron 50mg and Tamsulosin 0.4mg daily.

Drug: Mirabegron; Drug: Tamsulosin

Group D: Standard of Care

NO INTERVENTION

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

Interventions

Mirabegron DRUG

50 mg tablet orally once daily.

Group A: Mirabegron; Group C: Combination

Tamsulosin DRUG

0.4 mg tablet orally once daily.

Group B: Tamsulosin; Group C: Combination

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age and Sex: Adult patients aged 18 to 75 years, inclusive of both males and females.
• Diagnosis: Unilateral ureteral stone confirmed by Computed Tomography (CT), Renal Sonography, or Kidney-Ureter-Bladder (KUB) radiography.
• Stone Characteristics: Stone size between 4 mm and 10 mm; located in the upper (proximal), middle, or lower (distal) ureter.
• Symptoms and Renal Function: Presence of renal colic or hematuria, with no severe renal insufficiency (eGFR \> 60 mL/min/1.73m²).

You may not qualify if:

• Urinary tract infection (UTI).
• Multiple or bilateral ureteral stones.
• Ureteral stones not visible on KUB radiography (radiolucent stones).
• Pregnant or lactating women.
• Severe hydronephrosis.
• Renal insufficiency (defined as eGFR \< 30 mL/min/1.73m² or Serum Creatinine \> 2 mg/dL).
• Uncontrolled hypertension or major cardiovascular disease.
• Patients who refuse Medical Expulsive Therapy (MET).

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead

Study Sites (1)

Taipei Tzu Chi Hospital

New Taipei City, 231, Taiwan

Location

MeSH Terms

Conditions

Ureteral Calculi

Interventions

mirabegron; Tamsulosin

Condition Hierarchy (Ancestors)

Ureterolithiasis; Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Shu-Yu Wu, MD

  Taichung Tzu Chi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu-Yu Wu, Doctor of Medicine

CONTACT

+886-2-6628-9779; nobookrain2014@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Model Details: Participants are randomly assigned to one of four parallel treatment groups.

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)