Specified Drug Use Results Survey of Vesicare Tablets
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,160
- 主要终点
- Changes in OAB-q (overactive bladder questionnaire)
研究概览
简要总结
This study is to evaluate the effect of Vesicare on quality of life (QOL) in female patients.
详细描述
Overactive bladder (OAB) represents a constellation of symptoms that must include urinary urgency as an essential symptom for the diagnosis. It is usually accompanied by daytime frequency and nighttime frequency (urgency incontinence is not an essential symptom) and impairs the patient's activities of daily living and quality of life (QOL).
The objective of this survey is to confirm QOL improvement in patients treated with Vesicare (Generic Name: solifenacin succinate), with the use of OAB-q (Overactive bladder questionnaire), a questionnaire for assessment of OAB symptoms and QOL. The effect of improvement of OAB symptoms by solifenacin on QOL will also be confirmed. This survey will not include male OAB patients since many of them have benign prostatic hyperplasia as a coexisting disease and their QOL is supposed to be affected by α1-blocker treatment. To define patient's response to solifenacin in terms of QOL more clearly, this survey will include only female OAB patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Previously untreated OAB patients
- •Patients who meet the diagnostic criteria for OAB provided in the clinical guidelines for overactive bladder (patients who have urinary urgency at least once weekly as an essential symptom and at least one of the other OAB symptoms including daytime frequency, nighttime frequency, and urgency incontinence)
- •Patients who can understand and answer OAB-q (Japanese version)
- •Patients from whom data on all items concerning OABSS, OAB-q, and satisfaction score for urination can be obtained at baseline
- •Patients who are expected to be treated for at least 12 weeks
排除标准
- 未提供
研究组 & 干预措施
Vesicare group
Who receive vesicare
干预措施: Vesicare (Drug)
结局指标
主要结局
Changes in OAB-q (overactive bladder questionnaire)
时间窗: Baseline and at 12 weeks (or last observation period)
次要结局
- Changes in OABSS (overactive bladder symptom score)(Baseline and at 12 weeks (or last observation period))
- Changes in satisfaction score for urination(Baseline and at 12 weeks (or last observation period))