Comparison of Mirabegron and Tamsulosin for Ureteral Stone Expulsion

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

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

Treatments tested in this trial

  • Mirabegron
  • Tamsulosin

Treatment groups

500 Participants
are divided into 4 treatment groups