Health TrialsbyHealthPanel

Comparison of Mirabegron and Tamsulosin for Ureteral Stone Expulsion

ConditionUreteral Calculi
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTaipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Urinary tract infection (UTI).

Multiple or bilateral ureteral stones.

Ureteral stones not visible on KUB radiography (radiolucent stones).

Pregnant or lactating women.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mirabegron

    Drug

    50 mg tablet orally once daily.

  • Tamsulosin

    Drug

    0.4 mg tablet orally once daily.

Treatment groups

500 Participants
are divided into 4 treatment groups
Group A: Group A: MirabegronExperimental treatment 1 intervention
Group B: Group B: TamsulosinActive comparator 1 intervention
Group C: Group C: CombinationExperimental treatment 2 interventions
Group D: Group D: Standard of CareNo intervention 0 interventions

Trial outcomes

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.

Time frame
Up to 4 weeks

Secondary outcomes

1

Time to Stone Expulsion

The number of days from randomization to the confirmation of complete stone expulsion.

Time frame
Up to 4 weeks
2

Change in Pain Intensity

Assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain).

Time frame
Baseline and up to 4 weeks
3

Total Analgesic Consumption

The total amount of analgesic medication (e.g., NSAIDs, Tramadol, Acetaminophen) consumed by the participant to control pain.

Time frame
Up to 4 weeks
4

Change in Fatigue Symptoms

Assessed using the Fatigue Symptom Inventory (FSI) to measure the intensity and interference of fatigue.

Time frame
Baseline and up to 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Lead sponsor

Source ClinicalTrials.gov
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