At a glance
ClinicalIndex Comparison Record- ✓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
- ✓Willingness to follow-up in Urology Clinic in approximately 30 days and undergo ureteroscopic extraction if stone does not pass
- ✕Age less than 18 years
- ✕Multiple stones or solitary kidney or horseshoe kidney
- ✕History of ureteral surgery or previous endoscopic procedure
- ✕Allergy to mirabegron
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Mirabegron and Placebo for Ureteral Obstruction and Flank Pain. Completed, enrolled 33 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.