Postmarketing Observational Study of Tolterodine Treatment on Overactive Bladder in Real Life Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11,157
- 主要终点
- Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).
研究概览
简要总结
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Package Insert (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.
详细描述
All the subjects whom an investigator prescribes the first Detrusitol Capsule should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects intend to treat their overactive bladder who are prescribed Detrusitol Capsule by their physicians.
排除标准
- •Subjects who have been prescribed Detrusitol Capsule before.
研究组 & 干预措施
Tolterodine tartrate.
Subjects taking Tolterodine tartrate.
干预措施: Tolterodine tartrate (Drug)
结局指标
主要结局
Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).
时间窗: 12 weeks
All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
Number of Participants Which Was Evaluated as "Degree of Satisfaction".
时间窗: 12 week
Participant satisfaction was evaluated by investigators based on questioning the participants at the end of observation period using choices: Satisfied, Dissatisfied, Neither of the above.
Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study.
时间窗: 12 week
Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, etc, at the end of observation period.
Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period.
时间窗: 12 week
The Treatment Related Adverse Events (TRAEs) at the end of observation period with an incidence of 1% or higher.
次要结局
- Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs(12 week)
- Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies(12 week)
- Risk Factors for the Proportion of Responders of Tolterodine-Gender(12 week)
- Risk Factors for the Proportion of Responders of Tolterodine-Complications(12 week)
- Risk Factors for the Proportion of Responders of Tolterodine-Age(12 week)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy(12 week)
- Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants(12 week)
- Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder(12 week)
- Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency(12 week)
- Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep)(12 week)
- Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day(12 week)
- Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment(12 week)