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临床试验/NCT00985387
NCT00985387已完成不适用

Persistence of Solifenacin Treatment in Overactive Bladder Patients in Real Life Practice: A 12-month, Prospective, Multicenter, Open-label, Observational Study

Astellas Pharma Inc0 个研究点目标入组 1,215 人开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
1,215
主要终点
percentage of patients who are maintaining solifenacin treatment

研究概览

简要总结

The purpose of the study is to assess patient's persistency in maintaining solifenacin treatment for overactive bladder.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Overactive bladder symptoms lasting for more than 3 months
  • The question 3 score of the overactive bladder symptom score(OABSS)≥ 2 and the sum score of OABSS ≥ 3
  • Symptoms of urinary urgency defined as a level of 1 to 2 in a 3-point Urgency Perception Scale (UPS)

排除标准

  • Any condition that would contraindicate their usage of anticholinergic treatment, including: urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis
  • Symptomatic acute urinary tract infection (UTI)
  • Diagnosed or suspected of interstitial cystitis
  • Treatment with anticholinergic drugs for over 3 months within 12 months prior to the study
  • Pregnant or nursing women
  • Treatment within the 14 days before the study or expected to initiate treatment during the study with any anticholinergic drugs other than solifenacin or treatment for overactive bladder with other drugs
  • Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion

研究组 & 干预措施

Solifenacin treatment

Male and female OAB patients who were treated with solifenacin

干预措施: Solifenacin (Drug)

结局指标

主要结局

percentage of patients who are maintaining solifenacin treatment

时间窗: Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12

次要结局

  • percentage of patients who discontinued solifenacin treatment(Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12)
  • percentage of patients who switched to other OAB medication(Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12)

研究者

申办方类型
Industry
责任方
Sponsor

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