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

NCT02744430 | Completed Phase 2 Results FDA Drug

• 1 other identifier: H-38959
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Ureteral Obstruction; Flank Pain

Keywords

Medical expulsive therapy; ureteral stone; stent pain

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Secondary Outcomes (1)

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

  2 months

Study Arms (2)

Arm 1 - Active

ACTIVE COMPARATOR

Mirabegron 50 mg orally once every 24 hours starting immediately

Drug: Mirabegron

Arm 2 - Placebo

PLACEBO COMPARATOR

Placebo orally once every 24 hours starting immediately

Other: Placebo

Interventions

Mirabegron 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.

Also known as: Myrbetriq

Arm 1 - Active

Placebo 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.

Arm 2 - Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Ben Taub General Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Ureteral Obstruction; Flank Pain; Ureterolithiasis

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urolithiasis

Results Point of Contact

• Title: Perla Ramirez
• Organization: Baylor College of Medicine

Perla.Ramirez@bcm.edu

713-798-8514

Study Officials

• Wesley A. Mayer, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 20, 2016
• Study Start: July 22, 2017
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: April 26, 2022
• Results First Posted: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)