Mirabegron as Medical Expulsive Therapy (MET) for Ureteral Stones and Ureteral Stent Pain
Condition: Ureteral Obstruction; Flank Pain
MeSH terms: Ureteral Calculi; Ureterolithiasis; Ureteral Obstruction; Flank Pain
Intervention: Mirabegron; Placebo
Intervention description: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet.; Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet.
Intervention MeSH terms: Mirabegron
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Medical expulsive therapy; ureteral stone; stent pain

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.
    

Eligibility 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