Mirabegron as Medical Expulsive Therapy (MET) for Ureteral Stones and Ureteral Stent Pain

• Status: Completed
• Trial end date: 2019-10-31
• Target enrollment: 0
• Participant gender: All

Summary

The study will be a prospective randomized double-blind placebo-controlled trial of mirabegron for medical expulsive therapy (MET) in patients with a CT (Computed Tomography) scan-proven ureteral stone between 4 to 10 mm undergoing expectant management.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Treatments: Mirabegron

Criteria

Inclusion Criteria:

• Single unilateral ureteral calculus 4 to 10 mm visible on CT scan within the ureter

• Serum creatinine within normal range

• Ability to tolerate oral fluids and oral pain medication

• Able to make informed medical decisions regarding consent

• Willingness to follow-up in the Urology Clinic in approximately 30 day

• Willing to undergo ureteroscopic extraction should the stone not pass in this time period

Exclusion Criteria:

• Adults unable to consent

• Age less than 18

• Multiple stones

• Solitary kidney

• Horseshoe kidney

• On immunosuppressant therapy

• On digoxin

• Uncontrolled hypertension (Systolic blood pressure > 170, diastolic blood pressure > 110)

• History of ureteral surgery or previous endoscopic procedure

• Allergy to mirabegron

• Current calcium antagonist or corticosteroid or tamsulosin usage

• Patients already taking a beta-adrenergic agonist medication

• Renal insufficiency [Glomerular Filtration Rate (GFR) less than 60]

• Patients with Childs B and C liver failure

• Signs of infection i. Temperature greater than 38 degrees Celsius ii. Urinalysis with any of the following positive:

1. Positive nitrites

2. White blood cell count greater than 15/hpf (high powered field)

3. Positive urine culture [defined as a single isolated bacterial species population of greater than 100,000 Colony Forming Units (CFU)]

• Patients with chronic pain already undergoing treatment with narcotic medications

• Pregnant women and nursing mothers

• Prisoners

• No working phone number