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

NCT ID: NCT02744430

Last Updated: 2022-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-22
• Study Completion Date: 2019-10-31

Brief 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.

Detailed 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.

Conditions

Ureteral Obstruction; Flank Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Arm 1 - Active

Mirabegron 50 mg orally once every 24 hours starting immediately

Group Type: ACTIVE_COMPARATOR

Mirabegron

Intervention Type: DRUG

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.

Arm 2 - Placebo

Placebo orally once every 24 hours starting immediately

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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.

Interventions

Mirabegron

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 Type: DRUG

Placebo

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 Type: OTHER

Other Intervention Names

Myrbetriq

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Wesley Adam Mayer

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wesley A. Mayer, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Ben Taub General Hospital

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Consent form

View Document

Document Type: Informed Consent Form: Consent Form

View Document

Other Identifiers

H-38959

Identifier Type: -

Identifier Source: org_study_id