Actively Recruiting

Phase 4
Age: 18Years - 75Years
All Genders
ID07310797

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

Led by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation · Updated on 2026-06-08

500

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating four different treatment strategies to help people with ureteral stones pass them more easily. This trial compares Mirabegron alone, Tamsulosin alone, their combination, and standard conservative care. The main goal is to see which treatment leads to the highest rate of stone expulsion within four weeks, while also looking at pain levels, use of pain relief medicine, fatigue symptoms, and possible side effects like palpitations or blood pressure changes. Participants will be randomly assigned to one of four groups: one taking Mirabegron 50 mg daily, another taking Tamsulosin 0.4 mg daily, a third group taking both medications daily, and a fourth group receiving standard care with pain control through NSAIDs or other analgesics as needed. Treatment lasts up to four weeks, during which symptoms and safety are monitored closely. During the study, participants will have their stone expulsion status checked along with assessments of pain intensity using a visual scale, fatigue symptoms, and total pain medication taken. Researchers will also record any adverse events throughout the treatment period. The study helps provide options for managing ureteral stones using medical expulsive therapy over a one-month period.

CONDITIONS

Brief Title

Comparison of Mirabegron and Tamsulosin for Ureteral Stone Expulsion

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 75 years, including both males and females
  • Confirmed unilateral ureteral stone diagnosed by CT, renal sonography, or KUB radiography
  • Stone size between 4 mm and 10 mm located in the upper, middle, or lower ureter
  • Presence of renal colic or hematuria with normal kidney function (eGFR > 60 mL/min/1.73m²)
Not Eligible

You will not qualify if you...

  • Presence of urinary tract infection
  • Multiple or bilateral ureteral stones
  • Ureteral stones not visible on KUB radiography (radiolucent stones)
  • Pregnant or breastfeeding women
  • Severe hydronephrosis
  • Significant renal insufficiency (eGFR < 30 mL/min/1.73m² or Serum Creatinine > 2 mg/dL)
  • Uncontrolled high blood pressure or major heart disease
  • Refusal of Medical Expulsive Therapy (MET)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey: What to Expect

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 4 weeks

Participants receive assigned medication or standard conservative management to facilitate ureteral stone expulsion and improve clinical symptoms.

Weekly visits for up to 4 weeks

Trial Site Locations

Total: 1 location

1

Taipei Tzu Chi Hospital

New Taipei City, Taiwan, 231

Actively Recruiting

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Research Team

S

Shu-Yu Wu, Doctor of Medicine

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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Frequently Asked Questions

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