Clinical trial NCT02744430: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ureteral Obstruction
Flank Pain
Keywords: Medical expulsive therapy
ureteral stone
stent pain
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

  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

Primary outcomes:
measure: Spontaneous Stone Passage Using Fisher's Exact Test
timeFrame: 30 days
Secondary outcomes:
measure: Comparison of Pain Levels Between Treatment Groups Using the Wong-Baker Pain Rating Scale
timeFrame: 2 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Wesley A. Mayer, MD
role: PRINCIPAL_INVESTIGATOR
References: