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

Primary Purpose

Ureteral Obstruction, Flank Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mirabegron
Placebo
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ureteral Obstruction focused on measuring Medical expulsive therapy, ureteral stone, stent pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ben Taub General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm 1 - Active

Arm 2 - Placebo

Arm Description

Mirabegron 50 mg orally once every 24 hours starting immediately

Placebo orally once every 24 hours starting immediately

Outcomes

Primary Outcome Measures

Spontaneous Stone Passage Using Fisher's Exact Test
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

Comparison of Pain Levels Between Treatment Groups Using the Wong-Baker Pain Rating Scale
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.

Full Information

First Posted
April 12, 2016
Last Updated
April 4, 2022
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02744430
Brief Title
Mirabegron as Medical Expulsive Therapy (MET) for Ureteral Stones and Ureteral Stent Pain
Official Title
A Double Blind Placebo Control Trial of Mirabegron for Medical Expulsive Therapy and to Manage Stent Pain for Ureteral Stones(Protocol # 01-16-20-02)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 22, 2017 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteral Obstruction, Flank Pain
Keywords
Medical expulsive therapy, ureteral stone, stent pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 - Active
Arm Type
Active Comparator
Arm Description
Mirabegron 50 mg orally once every 24 hours starting immediately
Arm Title
Arm 2 - Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo orally once every 24 hours starting immediately
Intervention Type
Drug
Intervention Name(s)
Mirabegron
Other Intervention Name(s)
Myrbetriq
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.
Intervention Type
Other
Intervention Name(s)
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.
Primary Outcome Measure Information:
Title
Spontaneous Stone Passage Using Fisher's Exact Test
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Comparison of Pain Levels Between Treatment Groups Using the Wong-Baker Pain Rating Scale
Description
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.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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: Positive nitrites White blood cell count greater than 15/hpf (high powered field) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wesley A. Mayer, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ben Taub General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be published in a aggregate format after completion of study.

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

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