JPRN-UMIN000012804已完成未知
Mirabegron,beta-3 adrenoceptor agonist, Evaluate on efficacy, tolerability and QOL,in female overactive bladder with nocturia - Mirabegron,beta-3 adrenoceptor agonist, Evaluate on efficacy, tolerability and QOL,in female overactive bladder with nocturia (METEOR STUDY)
-QOL Study Group0 个研究点目标入组 100 人开始时间: 2014年1月10日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 50years-old 至 ot applicable（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •(1)Patients with a history of hypersensitivity to mirabegron (2)Patients with a severe heart disease [Mirabegron might worsen the heart disease since some adverse reactions such as heart rate elevation by mirabegron have been reported] (3)Patients on medication with anti-arrhythmics, such as flecainide acetate or propafenone hydrochloride (4)Patients with long QT syndrome (5)Patients prone to occur arrhythmia such as severe bradycardia or acute myocardial ischemia (6)Patients who were taking anticholinergic drugs to treat OAB less than 3 months before study participation (7)Patients with hypokalemia (8)Patients with difficult-to-control hypertension (systolic blood pressure >=180 mmHg or diastolic blood pressure >=110 mmHg, in a seated position) (9)Patients with severe liver dysfunction (10)Patients with renal failure (11)Patients with glaucoma (12)Patients with urination difficulty (13)Patients with anuresis (14)Patients whose residual urinary volume during the observational period is more than 100 mL (15)Patients under treatment with placement of catheter or intermittent self-catheterization (16)Patients whose urinary volume is more than 40mL/kg a day on average (17)Patients complicated with urinary infection, urinary lithiasis or interstitial cystitis (18)Patients complicated with bladder tumor (19)Patients undergone surgical operation that might affect their urinary function within 6 months prior to study participation (20)Patients who received non-drug therapy such as electrical stimulation (low-frequency therapy and magnetic stimulation, for example), biofeedback procedure, bladder training or pelvic floor muscle exercise within 6 months prior to initiation of the observational period (21)Patients complied with/or with a history of mood disorder, psychoneurotic disorder or schizophrenia (22)Patients considered as ineligible for this study by the investigator for other reasons
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