Pilot Study: Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women, an Open Label Study With Dose Escalation
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The number of pain motivated voids per 24 hours.
研究概览
简要总结
The specific purpose of this study is to provide objective data in prospective open label design (n=40) to support the use of Mirabegron as a treatment for pain related urinary frequency and urgency. Women with bladder pain have a poor response to traditional anticholinergic therapy for their symptoms of frequency and urgency.
详细描述
Hypothesis: Mirabegron is effective in reducing symptoms in women with pain related urinary frequency and urgency.
Specific Aims:
- To measure the efficacy of Mirabegron in the treatment of frequency and urgency, using voiding diaries.
- To measure the number of patients with a 50% or greater reduction in frequency and urgency, using voiding diaries.
- To measure the number of patients with a 50% or greater reduction in bladder pain as measured in the O'Leary-Sant (OLS) IC symptom and problem, and the Lowell Parsons Pelvic Pain and Urgency/Frequency (PUF) patient symptom scale.
Intervention/Project goal: Treatment with Mirabegron 25mg for 4 weeks with an option for dose escalation to 50mg. Duration of study 12 weeks.
Inclusion criteria: Women between the ages of 18 and 89 with complaints of pain related urinary frequency are eligible to participate in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English-speaking women
- •Age: 18 and 89 years
- •Pain related urinary frequency or urgency associated with >70% of voids. With a minimum of 7 pain motivated voids in 24 hours.
- •Bladder capacity: > 300 ml
- •Urinary frequency: 10 or more voids in 24/hours on voiding diary
排除标准
- •Severe Liver disease: Child-Pugh class c
- •Severe Kidney disease: GFR<30
- •Elevated blood pressure > 160/95 (in package insert bp >180/110)
- •Pregnant, will become pregnant, or are nursing during the study
- •History of recurrent urinary tract infection: 3 or more culture proven urinary tract infections in the past 12 months. An active urinary tract infection.
- •Tachycardia: pulse > 100, or any other history of arrhythmia
- •Intense urge: bladder volumes of <150 ml on cystometry
- •Presently on study drug mirabegron; patient must be willing to participate in a 30 day washout period to be eligible for inclusion
- •Medications: metoprolol, desipramine, digoxin, propafenone, thioridazine, flecainide, warfarin
- •Pain medications: no dose changes in narcotic or non-steroidal medications while on study. Patient must be on a stable medication dose for at least 30 days prior to the screening visit.
- •Neurogenic pain medications such as gabapentin or amitriptyline: no dose changes while on study. Patient must be on a stable medication dose for at least 30 days prior to the screening visit.
- •Anticholinergic medications for incontinence: no dose changes while on study. Patient must be on a stable medication dose for at least 30 days prior to the screening visit.
研究组 & 干预措施
Mirabegron 25 mg or 50 mg
干预措施: Mirabegron (Drug)
结局指标
主要结局
The number of pain motivated voids per 24 hours.
时间窗: 12 weeks
次要结局
- The Mean change in global urinary symptoms based upon scores from the Urgency Severity and Impact Questionnaire (USIQ)(12 weeks)
- The mean change in the Patient Perception of Bladder Condition (PPBC)(12 weeks)
- The mean change from baseline to end of study in the daily average number of voids(12 weeks)
研究者
Tova Ablove
Principal Investigator
State University of New York at Buffalo