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)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Spontaneous Stone Passage Using Fisher's Exact Test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm 1 - Active
Mirabegron 50 mg orally once every 24 hours starting immediately
干预措施: Mirabegron (Drug)
Arm 2 - Placebo
Placebo orally once every 24 hours starting immediately
干预措施: Placebo (Other)
结局指标
主要结局
Spontaneous Stone Passage Using Fisher's Exact Test
时间窗: 30 days
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.
次要结局
- Comparison of Pain Levels Between Treatment Groups Using the Wong-Baker Pain Rating Scale(2 months)
研究者
Wesley Adam Mayer
Assistant Professor
Baylor College of Medicine