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

Phase 2

Completed

• Conditions: Flank Pain; Ureteral Obstruction
• Interventions: Other: Placebo; Drug: Mirabegron

• Registration Number: NCT02744430
• Lead Sponsor: Baylor College of Medicine

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.

Study Timeline

• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-20
• Study Start: 2017-07-22
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Results First Submitted: 2020-10-02
• Status Verified: 2022-04
• Results First Submitted QC: 2022-04-04
• Last Update Submitted: 2022-04-04
• Results First Posted: 2022-04-26
• Last Update Posted: 2022-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2 - Placebo	Placebo	Placebo orally once every 24 hours starting immediately
Arm 1 - Active	Mirabegron	Mirabegron 50 mg orally once every 24 hours starting immediately

Primary Outcome Measures

Name	Time	Method
Spontaneous Stone Passage Using Fisher's Exact Test	30 days	The primary outcome was stone passage rate at 30-days defined by either imaging (CT or Renal Ultrasound/KUB) or identification of stone using a straining device.

Secondary Outcome Measures

Name	Time	Method
Comparison of Pain Levels Between Treatment Groups Using the Wong-Baker Pain Rating Scale	2 months	Pain measures between treatment groups will be measured daily for each patient by using the Wong-Baker Pain Rating Scale. The Questionnaire will be observed in patients who require surgical intervention, and will be observed during study visit. A general linear model will be used to compare Wong-Baker pain scores between the treated and placebo groups. The model will also be used to explore associations between pain scores and demographic or clinical characteristics adjusting for treatment group.

Trial Locations

Locations (1)

Ben Taub General Hospital; 🇺🇸 Houston, Texas, United States