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

Baylor College of Medicine

Status and phase: Completed; Phase 2

Conditions: Ureteral Obstruction; Flank Pain

Treatments: Drug: Mirabegron; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02744430

H-38959

Details and patient eligibility

About

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.

Full description

The study will be a prospective randomized double-blind placebo-controlled trial of mirabegron for medical expulsive therapy (MET) in patients with a CT scan-proven ureteral stone between 4 to 10 mm undergoing expectant management. Subjects will be distributed at a 1:1 ratio between the control and treatment groups. The treatment group will receive mirabegron and the control groups will receive a placebo. Both groups will receive analgesics and hydration will be recommended. All subjects will then be followed for 30 days to determine the proportion of subjects with spontaneous passage. Patients will record narcotic usage and pain scores during this time. If there is stone persistence in the ureter based on imaging (CT scan of the abdomen and pelvis versus renal ultrasound plus KUB), then the patient will undergo ureteroscopy with stent placement. In these patients, treatment will continue while the stent is in place and patients will fill out a validated questionnaire regarding stent pain.

Enrollment: 33 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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33 participants in 2 patient groups, including a placebo group

Arm 1 - Active

Active Comparator group

Description:

Mirabegron 50 mg orally once every 24 hours starting immediately

Treatment:

Drug: Mirabegron

Arm 2 - Placebo

Placebo Comparator group

Description:

Placebo orally once every 24 hours starting immediately

Treatment:

Other: Placebo