NCT02744430

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ureteral Obstruction
• Flank Pain

Interventions

Type	Name	Description
DRUG	Mirabegron	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.
OTHER	Placebo	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.

Timeline

• Start date: 2017-07-22
• Primary completion: 2019-10-31
• Completion: 2019-10-31
• First posted: 2016-04-20
• Last updated: 2022-04-26
• Results posted: 2022-04-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study