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.
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.
Study Type
OBSERVATIONAL
Enrollment
11,157
Detrusitol Capsule 2mg and 4mg, depending on the Investigator prescription.Frequency and duration are according to Package Insert as follows.
Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).
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.
Time frame: 12 weeks
Number of Participants Which Was Evaluated as "Degree of Satisfaction".
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.
Time frame: 12 week
Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study.
Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, etc, at the end of observation period.
Time frame: 12 week
Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period.
The Treatment Related Adverse Events (TRAEs) at the end of observation period with an incidence of 1% or higher.
Time frame: 12 week
Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs
Number of participants with responders of tolterodine to determine whether with or without concomitant drugs is significant risk factor.
Time frame: 12 week
Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies
Number of participants with responders of tolterodine to determine whether with or without Non-drug therapies is significant risk factor.
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Time frame: 12 week
Risk Factors for the Proportion of Responders of Tolterodine-Gender
Number of participants with responders of tolterodine to determine whether male or female is significant risk factor.
Time frame: 12 week
Risk Factors for the Proportion of Responders of Tolterodine-Complications
Number of participants with responders of tolterodine to determine whether with or without complications is significant risk factor.
Time frame: 12 week
Risk Factors for the Proportion of Responders of Tolterodine-Age
Number of participants with responders of tolterodine to determine whether \<65 years or \>=65 years is significant risk factor.
Time frame: 12 week
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy
Number of participants with Treatment Related Adverse Events (TRAEs) of tolterodine to determine whether with or without comorbidity of benign prostatic hypertrophy (BPH) is significant risk factor.
Time frame: 12 week
Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants
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. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.
Time frame: 12 week
Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder
Number of participants with responders of tolterodine to determine whether mild, moderate or severe is significant risk factor.
Time frame: 12 week
Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency
Number of participants with responders of tolterodine to determine whether with or without Urinary urgency is significant risk factor.
Time frame: 12 week
Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep)
Number of participants with responders of tolterodine to determine the Number of urinations per day (during sleep) is significant risk factor.
Time frame: 12 week
Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day
Number of participants with responders of tolterodine to determine the Number of urinary incontinence episodes per day is significant risk factor.
Time frame: 12 week
Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment
Number of participants with response to tolterodine to determine whether with or without previous treatment is significant risk factor.
Time frame: 12 week