Phase 2
N=33
Mirabegron as Medical Expulsive Therapy (MET) for Ureteral Stones and Ureteral Stent Pain
Ureteral Obstruction · Flank Pain
Bottom Line
View on ClinicalTrials.gov: NCT02744430 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Spontaneous Stone Passage Using Fisher's Exact Test — 8; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mirabegron (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Spontaneous Stone Passage Using Fisher's Exact Test |
8; 5 | — |
| SECONDARY Comparison of Pain Levels Between Treatment Groups Using the Wong-Baker Pain Rating Scale |
0.21; 0.19 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02744430). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.